A study published in this month's issue of the Journal of Periodontology found that subjects with periodontitis who were exposed to secondhand smoke were more likely to develop bone loss, the number one cause of tooth loss.
Researchers studied rats that were induced with periodontal disease. One group was not exposed to cigarette smoke while the other two groups were exposed to either 30 days of smoke inhalation produced by non-light cigarettes (cigarettes containing higher tar, nicotine and carbon monoxide levels) or light cigarettes (cigarettes containing lower tar, nicotine and carbon monoxide levels). Results showed that bone loss was greater in the subjects exposed to secondhand smoke regardless of if it was smoke from light or non-light cigarettes than those who were exposed to no smoke at all.
"Previous clinical research has proven a strong positive correlation between smoking and gum disease. However, this study is unique in that it evaluated the impact of secondhand smoke on periodontitis," explained study author Getulio da R. Nogueira-Filho, DDS.
"This study really drives home the fact that even if you don't smoke the effects of secondhand smoke can be devastating. Part of maintaining a healthy lifestyle should include avoiding smoke filled places such as nightclubs, bars and even some restaurants," said Preston D. Miller, Jr., DDS and AAP president. "The Academy applauds the cities that are taking steps to make their hospitality industries smoke free so all patrons can enjoy not only a good time but also good overall health."
Cigarette smoking may be the major preventable risk factor for periodontal disease. To asses your oral health, take the AAP's online test to assess your gum disease risk. A referral to a periodontist in your area and free brochure samples including Periodontal Diseases: What You Need to Know and Tobacco and Periodontal Diseases: Targeting Tobacco Use are available by calling 800-FLOSS-EM (800-356-7736) or visiting the AAP's Web site at perio.
Click here for more about the links between smoking and periodontal disease please located on the AAP Web site.
The American Academy of Periodontology is an 8,000-member association of dental professionals specializing in the prevention, diagnosis and treatment of diseases affecting the gums and supporting structures of the teeth and in the placement and maintenance of dental implants. Periodontics is one of nine dental specialties recognized by the American Dental Association.
NOTE: A copy of the Journal of Periodontology article "Low-and high-yield cigarette smoke inhalations potentiates bone loss during ligature-induced periodontitis" is available online for $20.00 at joponline/. A study abstract is also available online.
Contact: Kerry Gutshall
American Academy of Periodontology
суббота, 30 апреля 2011 г.
пятница, 29 апреля 2011 г.
Men, Young Adults Tend To Downplay Osteoporosis Risk
Young adults and men do not see themselves as susceptible to osteoporosis, according to a new study. In their minds, the risk of suffering from what many consider an older woman's disease seems distant or slim. The problem: They are missing preventive measures that if taken now, could decrease their future danger of developing the disease.
In the study of 300 Canadian men and women, researchers found significant age and gender differences in how people perceived their susceptibility to osteoporosis. Specifically, middle-aged and older women scored significantly higher than younger participants and men, suggesting that older women believe they are at greater risk.
"The low scores among younger people raise concerns for the approaching epidemic," said Shanthi Johnson, Ph.D., lead study author and a professor at University of Regina. "Given the aging population and the growing percentage of older women within that population, osteoporosis should receive more recognition."
The study appears in the October issue of the journal Health Education & Behavior.
According to Osteoporosis Canada, the disease is a debilitating one that weakens bones and increases the risk of fractures. Twenty percent of those who experience osteoporosis-based hip fractures die; another 50 percent suffer permanent disabilities.
While the disease does strike twice as many older women as it does men, men are also susceptible to osteoporosis. Because people can change their habits to lower their risk, researchers are looking at people's beliefs in order to develop and target prevention programs to the particular needs of each demographic.
The best defense against the disease is building strong bones in childhood and young adulthood. Anybody can reduce their risk, however, by eating a well-balanced diet that is high in calcium and vitamin D and by participating in weight-bearing exercises or sports.
In the study, motivation to take preventive action and the perceived seriousness of the disease were similar across all age and gender groups low suggesting that people are not aware of the serious consequences of osteoporosis and that younger men and women are unlikely to change their behavior unless they change their beliefs.
Karen Chapman-Novakofski, Ph.D., at the University of Illinois at Champaign-Urbana, is encouraged that the susceptibility scores in Johnson's study show some progress in awareness. "Years ago," she said, "we found that younger women thought older women should know more about the condition and that older women thought it was too late for them, and that younger women should know more."
Health Education & Behavior, a peer-reviewed journal of the Society for Public Health Education (SOPHE), publishes research on critical health issues for professionals in the implementation and administration of public health information programs. For information, contact Elaine Auld at (202) 408-9804.
Johnson CS, et al. Osteoporosis health beliefs among younger and older men and women. Health Education & Behavior 34(5), 2008.
Health Behavior News Service
Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210
Washington, DC 20009
United States
hbns
In the study of 300 Canadian men and women, researchers found significant age and gender differences in how people perceived their susceptibility to osteoporosis. Specifically, middle-aged and older women scored significantly higher than younger participants and men, suggesting that older women believe they are at greater risk.
"The low scores among younger people raise concerns for the approaching epidemic," said Shanthi Johnson, Ph.D., lead study author and a professor at University of Regina. "Given the aging population and the growing percentage of older women within that population, osteoporosis should receive more recognition."
The study appears in the October issue of the journal Health Education & Behavior.
According to Osteoporosis Canada, the disease is a debilitating one that weakens bones and increases the risk of fractures. Twenty percent of those who experience osteoporosis-based hip fractures die; another 50 percent suffer permanent disabilities.
While the disease does strike twice as many older women as it does men, men are also susceptible to osteoporosis. Because people can change their habits to lower their risk, researchers are looking at people's beliefs in order to develop and target prevention programs to the particular needs of each demographic.
The best defense against the disease is building strong bones in childhood and young adulthood. Anybody can reduce their risk, however, by eating a well-balanced diet that is high in calcium and vitamin D and by participating in weight-bearing exercises or sports.
In the study, motivation to take preventive action and the perceived seriousness of the disease were similar across all age and gender groups low suggesting that people are not aware of the serious consequences of osteoporosis and that younger men and women are unlikely to change their behavior unless they change their beliefs.
Karen Chapman-Novakofski, Ph.D., at the University of Illinois at Champaign-Urbana, is encouraged that the susceptibility scores in Johnson's study show some progress in awareness. "Years ago," she said, "we found that younger women thought older women should know more about the condition and that older women thought it was too late for them, and that younger women should know more."
Health Education & Behavior, a peer-reviewed journal of the Society for Public Health Education (SOPHE), publishes research on critical health issues for professionals in the implementation and administration of public health information programs. For information, contact Elaine Auld at (202) 408-9804.
Johnson CS, et al. Osteoporosis health beliefs among younger and older men and women. Health Education & Behavior 34(5), 2008.
Health Behavior News Service
Center for the Advancement of Health, 2000 Florida Ave. NW, Ste. 210
Washington, DC 20009
United States
hbns
четверг, 28 апреля 2011 г.
Elderly Falls Cut By 11 Percent With Education And Intervention
Commonly viewed as an inevitable consequence of aging and often ignored in clinical practice, falls among the elderly were cut by 11 percent when researchers at Yale School of Medicine used a combination of fall prevention educational campaigns and interventions aimed at encouraging clinicians to incorporate fall-risk assessment and management into their practices.
Published in the July 17 New England Journal of Medicine, the study also found that the fall prevention programs resulted in almost 10 percent fewer fall-related hip fractures and head injuries among the elderly, who receive their care from a broad range of health providers in the intervention area.
The study was conducted by Mary E. Tinetti, M.D., the Gladys Phillips Crofoot Professor of Medicine, epidemiology and public health and investigative medicine at Yale School of Medicine, and colleagues.
It is the first study to examine the effects of fall prevention strategies when used by clinicians who care for the elderly. Previous trials studied fall prevention carried out by researchers, not by elderly patients' own health providers. The study targeted primary care physicians, rehabilitation specialists (physical and occupational therapists), home care nurses, hospital emergency room staff and other clinicians and providers.
Tinetti and her team compared the rates of serious fall injury and health care related to falls among people age 70 and older in two regions of Connecticut. For four years, health care providers in the greater Hartford region were contacted as part of a multi-component program targeting poor balance, vision loss, medication use, improper footwear, and blood pressure drops upon standing. Clinicians were encouraged to cut medications and increase physical therapy referrals among other proven fall prevention strategies. About 3,000 clinicians, administrators and policy experts in this region also received fall prevention information in the form of brochures, seminars, posters and patient education materials. Those in the Southern Connecticut region followed the usual care practice.
"The 11 percent difference translates into about 1,800 fewer injuries, less discomfort and disability for the elderly and about $21 million less in health care costs in the region where the interventions took place, compared with the usual-care region," said Tinetti. "The data show that fall risk assessment and management can be embedded into practice. We weren't expecting such great results because it can be difficult to adapt new strategies into patient care. We are now looking at ways to make these interventions and strategies available to the rest of the state and country."
In past studies, Tinetti and her team identified effective strategies to prevent falls but she said they have been underutilized. "Falling doesn't have to be an inevitable part of age because it is preventable," she said.
Fall-related injuries are among the most common, disabling and expensive health conditions experienced by older adults. Falls account for 10 percent of emergency department visits and 6 percent of hospitalizations among those over age 65. Falls can also lead to functional decline, placement in a nursing home and restricted activity.
The study was supported by a grant from the Donaghue Foundation and by the Yale Pepper Center from the National Institute on Aging.
Other authors on the study include Dorothy I. Baker, Mary King, M.D., Margaret Gottschalk, Terrence E. Murphy, Denise Acampora, Bradley P. Carlin, Linda Leo-Summers and Heather G. Allore.
Citation: New England Journal of Medicine, Vol. 359 No. 3 (July 17, 2008)
yale
Published in the July 17 New England Journal of Medicine, the study also found that the fall prevention programs resulted in almost 10 percent fewer fall-related hip fractures and head injuries among the elderly, who receive their care from a broad range of health providers in the intervention area.
The study was conducted by Mary E. Tinetti, M.D., the Gladys Phillips Crofoot Professor of Medicine, epidemiology and public health and investigative medicine at Yale School of Medicine, and colleagues.
It is the first study to examine the effects of fall prevention strategies when used by clinicians who care for the elderly. Previous trials studied fall prevention carried out by researchers, not by elderly patients' own health providers. The study targeted primary care physicians, rehabilitation specialists (physical and occupational therapists), home care nurses, hospital emergency room staff and other clinicians and providers.
Tinetti and her team compared the rates of serious fall injury and health care related to falls among people age 70 and older in two regions of Connecticut. For four years, health care providers in the greater Hartford region were contacted as part of a multi-component program targeting poor balance, vision loss, medication use, improper footwear, and blood pressure drops upon standing. Clinicians were encouraged to cut medications and increase physical therapy referrals among other proven fall prevention strategies. About 3,000 clinicians, administrators and policy experts in this region also received fall prevention information in the form of brochures, seminars, posters and patient education materials. Those in the Southern Connecticut region followed the usual care practice.
"The 11 percent difference translates into about 1,800 fewer injuries, less discomfort and disability for the elderly and about $21 million less in health care costs in the region where the interventions took place, compared with the usual-care region," said Tinetti. "The data show that fall risk assessment and management can be embedded into practice. We weren't expecting such great results because it can be difficult to adapt new strategies into patient care. We are now looking at ways to make these interventions and strategies available to the rest of the state and country."
In past studies, Tinetti and her team identified effective strategies to prevent falls but she said they have been underutilized. "Falling doesn't have to be an inevitable part of age because it is preventable," she said.
Fall-related injuries are among the most common, disabling and expensive health conditions experienced by older adults. Falls account for 10 percent of emergency department visits and 6 percent of hospitalizations among those over age 65. Falls can also lead to functional decline, placement in a nursing home and restricted activity.
The study was supported by a grant from the Donaghue Foundation and by the Yale Pepper Center from the National Institute on Aging.
Other authors on the study include Dorothy I. Baker, Mary King, M.D., Margaret Gottschalk, Terrence E. Murphy, Denise Acampora, Bradley P. Carlin, Linda Leo-Summers and Heather G. Allore.
Citation: New England Journal of Medicine, Vol. 359 No. 3 (July 17, 2008)
yale
среда, 27 апреля 2011 г.
CONMED Corporation To Present At The Canaccord Adams Small Cap Orthopedics Conference On Tuesday, March 4, 2008
CONMED Corporation (Nasdaq: CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in The Canaccord Adams Small Cap Orthopedics Conference on Tuesday, March 4, 2008 at 1:30 PM Pacific time. The event will be held in San Francisco at the Mission Bay Conference Center.
Mr. Joseph J. Corasanti, President and Chief Executive Officer of CONMED, will discuss the Company's business. The live webcast of CONMED's presentation will be available at conmed in the Investor Relations - Events Calendar section of the website and will be available for replay through March 11, 2008.
CONMED Profile
CONMED is a medical technology company with an emphasis on surgical devices and equipment for minimally invasive procedures and patient monitoring. The Company's products serve the clinical areas of sports medicine-arthroscopy, powered surgical instruments, electrosurgery, cardiac monitoring disposables, endosurgery and endoscopic technologies. Surgeons and physicians in a variety of specialties including orthopedics, general surgery, gynecology, neurosurgery, and gastroenterology use the Company's medical devices. Headquartered in Utica, New York, the Company's 3,200 employees distribute its products worldwide from several manufacturing locations.
Forward Looking Information
Certain statements made in the presentation may constitute forward-looking statements. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company's performance on a going-forward basis. They will be based upon management's expectations and involve risks and uncertainties which could cause actual results, performance or trends, to differ materially from those expressed in the forward-looking statements therein or in previous disclosures. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management's expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct. In addition to general industry and economic conditions, factors that could cause actual results to differ materially from those discussed in the forward-looking statements include, but are not limited to: (i) the failure of any one or more of management's assumptions to prove to be correct; (ii) the risks relating to forward-looking statements discussed in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and Quarterly Reports on Form 10-Q; (iii) cyclical purchasing patterns from customers, end-users and dealers; (iv) timely release of new products, and acceptance of such new products by the market; (v) the introduction of new products by competitors and other competitive responses; (vi) the possibility that any new acquisition (and its integration) or other transaction may require the Company to reconsider its financial assumptions and goals/targets; (vii )increasing costs for raw material, transportation, or litigation; and/or (viii) the Company's ability to devise and execute strategies to respond to market conditions.
CONMED Corporation
Mr. Joseph J. Corasanti, President and Chief Executive Officer of CONMED, will discuss the Company's business. The live webcast of CONMED's presentation will be available at conmed in the Investor Relations - Events Calendar section of the website and will be available for replay through March 11, 2008.
CONMED Profile
CONMED is a medical technology company with an emphasis on surgical devices and equipment for minimally invasive procedures and patient monitoring. The Company's products serve the clinical areas of sports medicine-arthroscopy, powered surgical instruments, electrosurgery, cardiac monitoring disposables, endosurgery and endoscopic technologies. Surgeons and physicians in a variety of specialties including orthopedics, general surgery, gynecology, neurosurgery, and gastroenterology use the Company's medical devices. Headquartered in Utica, New York, the Company's 3,200 employees distribute its products worldwide from several manufacturing locations.
Forward Looking Information
Certain statements made in the presentation may constitute forward-looking statements. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company's performance on a going-forward basis. They will be based upon management's expectations and involve risks and uncertainties which could cause actual results, performance or trends, to differ materially from those expressed in the forward-looking statements therein or in previous disclosures. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management's expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct. In addition to general industry and economic conditions, factors that could cause actual results to differ materially from those discussed in the forward-looking statements include, but are not limited to: (i) the failure of any one or more of management's assumptions to prove to be correct; (ii) the risks relating to forward-looking statements discussed in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and Quarterly Reports on Form 10-Q; (iii) cyclical purchasing patterns from customers, end-users and dealers; (iv) timely release of new products, and acceptance of such new products by the market; (v) the introduction of new products by competitors and other competitive responses; (vi) the possibility that any new acquisition (and its integration) or other transaction may require the Company to reconsider its financial assumptions and goals/targets; (vii )increasing costs for raw material, transportation, or litigation; and/or (viii) the Company's ability to devise and execute strategies to respond to market conditions.
CONMED Corporation
вторник, 26 апреля 2011 г.
Vitamin D Deficiency Puts IBD Patients At Greater Risk Of Osteoporosis
Vitamin D deficiency puts patients with Inflammatory Bowel Disease (IBD) at greater risk of osteoporosis, osteopenia and an overall higher rate of abnormal bone density, according to the results of a new study unveiled today at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio, Texas.
The study, "Vitamin D Deficiency and Abnormal DEXA Scans in Inflammatory Bowel Disease Patients," found that of the 161 IBD patients in the cohort, reduction in bone density with a diagnosis of osteoporosis or osteopenia was found in 22 percent of these patients, 50 percent of whom were under age 50.
IBD is a fairly common condition affecting more than one million people in the United States. The number of IBD patients is split equally between those with Crohn's disease and those with ulcerative colitis. Children and adults with IBD between the ages of 10 and 70 participated in the prospective study between 2008 and 2010. Vitamin D deficiency was defined as Vitamin D 25-hydroxy levels less than 30ng/mL. DEXA scan results were considered abnormal if osteopenia and osteoporosis were found.
"IBD patients with an abnormal bone density exam had a significantly higher rate of Vitamin D deficiency than those who had normal DEXA scans," said Dr. Bincy P. Abraham, Assistant Professor of Medicine, Baylor College of Medicine and Director, Baylor Clinic Inflammatory Bowel Disease Program.
Dr. Abraham, who presented the findings, said that previous research has suggested a high prevalence of osteoporosis and overall abnormal bone density in IBD patients that is likely caused by corticosteroid use and excess of inflammatory cytokines, as well as from calcium and Vitamin D malabsorption.
"We aimed to determine the association between Vitamin D deficiency and abnormal bone density in IBD patients," said Dr. Abraham.
According the study, Crohn's disease patients with Vitamin D deficiency were four times more likely to have a higher rate of abnormal bone density exams compared to patients with ulcerative colitis.
"This finding is not surprising since Crohn's disease usually affects the small intestine, which is the part of the gut that absorbs the most nutrients," said Dr. Abraham. "The widespread malabsorption in Crohn's disease does not occur in ulcerative colitis, which involves only the colon."
However, both Crohn's disease and ulcerative colitis patients diagnosed with osteoporosis had a significantly higher rate of Vitamin D deficiency irrespective of prednisone intake, according to the study.
"Abnormal bone density was relatively high among our IBD patients with Vitamin D deficiency irrespective to age, gender or corticosteroid use that would place them at a significantly higher risk of having an abnormal DEXA result," said Dr. Abraham. "It remains important for those caring for IBD patients to evaluate for Vitamin D nutritional deficiency and for its potential consequence of osteopenia or osteoporosis."
Source:
American College of Gastroenterology
The study, "Vitamin D Deficiency and Abnormal DEXA Scans in Inflammatory Bowel Disease Patients," found that of the 161 IBD patients in the cohort, reduction in bone density with a diagnosis of osteoporosis or osteopenia was found in 22 percent of these patients, 50 percent of whom were under age 50.
IBD is a fairly common condition affecting more than one million people in the United States. The number of IBD patients is split equally between those with Crohn's disease and those with ulcerative colitis. Children and adults with IBD between the ages of 10 and 70 participated in the prospective study between 2008 and 2010. Vitamin D deficiency was defined as Vitamin D 25-hydroxy levels less than 30ng/mL. DEXA scan results were considered abnormal if osteopenia and osteoporosis were found.
"IBD patients with an abnormal bone density exam had a significantly higher rate of Vitamin D deficiency than those who had normal DEXA scans," said Dr. Bincy P. Abraham, Assistant Professor of Medicine, Baylor College of Medicine and Director, Baylor Clinic Inflammatory Bowel Disease Program.
Dr. Abraham, who presented the findings, said that previous research has suggested a high prevalence of osteoporosis and overall abnormal bone density in IBD patients that is likely caused by corticosteroid use and excess of inflammatory cytokines, as well as from calcium and Vitamin D malabsorption.
"We aimed to determine the association between Vitamin D deficiency and abnormal bone density in IBD patients," said Dr. Abraham.
According the study, Crohn's disease patients with Vitamin D deficiency were four times more likely to have a higher rate of abnormal bone density exams compared to patients with ulcerative colitis.
"This finding is not surprising since Crohn's disease usually affects the small intestine, which is the part of the gut that absorbs the most nutrients," said Dr. Abraham. "The widespread malabsorption in Crohn's disease does not occur in ulcerative colitis, which involves only the colon."
However, both Crohn's disease and ulcerative colitis patients diagnosed with osteoporosis had a significantly higher rate of Vitamin D deficiency irrespective of prednisone intake, according to the study.
"Abnormal bone density was relatively high among our IBD patients with Vitamin D deficiency irrespective to age, gender or corticosteroid use that would place them at a significantly higher risk of having an abnormal DEXA result," said Dr. Abraham. "It remains important for those caring for IBD patients to evaluate for Vitamin D nutritional deficiency and for its potential consequence of osteopenia or osteoporosis."
Source:
American College of Gastroenterology
понедельник, 25 апреля 2011 г.
Little League Elbow: Is Your Child At Risk?
"Over the top!", "Don't Aim!", "Push off the rubber!" If these phrases are all too familiar to you while at a ball game, they could be causing more harm than good. Sports Medicine specialist, Raphael Longobardi, MD of the University Orthopaedic Center in Hackensack, NJ, is seeing more athletes, younger than ever before, coming in with overuse injuries, particularly "Little League elbow" due to the pressures of pitching and the increase of organized sports beyond a regular season.
"Little League Elbow is an injury to the growth plate inside the elbow joint, most commonly due to excessive throwing. The age group most affected is anywhere from ages 10-15, primarily ages 12-14. The combination of joint being immature, and the increased competition and intensity level at that age, definitely increases the chances of injury to the growth plate in the elbow, and sometimes causing it to separate. In some cases, if not detected early, can lead to surgery," explains Dr. Longobardi. "Although the symptoms gradually build up, the elbow eventually becomes sore to the touch. The most characteristic symptom is when the player experiences pain with throwing the ball, decreased velocity or distance, and sometimes diminished effectiveness. A clinical exam and an x-ray will confirm the diagnosis."
While there are many age guidelines to follow in regards to pitching and throwing, coaches and parents need to be aware of proper ways to prevent overuse injuries including, but not limited to, proper warm ups (stretching, running and easy, gradual throwing); a trained teacher or coach to help supervise a team; and for parents, a loss of enthusiasm by your child or continuous rubbing of the a sore area, could be warning signs of pain. Dr. Longobardi adds, "Ignoring these signs and symptoms can dramatically affect a child's chances to continue playing baseball or softball. If an injury is overlooked today, it can result in future damage that could be more difficult to correct."
Dr. Longobardi, a graduate of New York University School of Medicine and member of the American Academy of Orthopaedic Surgeons and numerous other medical associations, is an Assistant Professor of Clinical Orthopaedic Surgery at NYU Medical Center and has been honored by the Lillian S. Lusskin Orthopaedic Foundation for Excellence in Teaching. He is affiliated with Hackensack Medical Center, Holy Name Hospital and New York University Medical Center and the Hospital for Joint Diseases in New York City. Dr. Longobardi has also served as Team Physician to the Florida Marlins Baseball Team, the U.S. Tennis Association, the NY/NJ MetroStars Soccer Team, the New York Islanders Hockey Team, and numerous other professional and collegiate sports teams.
University Orthopaedic Center
"Little League Elbow is an injury to the growth plate inside the elbow joint, most commonly due to excessive throwing. The age group most affected is anywhere from ages 10-15, primarily ages 12-14. The combination of joint being immature, and the increased competition and intensity level at that age, definitely increases the chances of injury to the growth plate in the elbow, and sometimes causing it to separate. In some cases, if not detected early, can lead to surgery," explains Dr. Longobardi. "Although the symptoms gradually build up, the elbow eventually becomes sore to the touch. The most characteristic symptom is when the player experiences pain with throwing the ball, decreased velocity or distance, and sometimes diminished effectiveness. A clinical exam and an x-ray will confirm the diagnosis."
While there are many age guidelines to follow in regards to pitching and throwing, coaches and parents need to be aware of proper ways to prevent overuse injuries including, but not limited to, proper warm ups (stretching, running and easy, gradual throwing); a trained teacher or coach to help supervise a team; and for parents, a loss of enthusiasm by your child or continuous rubbing of the a sore area, could be warning signs of pain. Dr. Longobardi adds, "Ignoring these signs and symptoms can dramatically affect a child's chances to continue playing baseball or softball. If an injury is overlooked today, it can result in future damage that could be more difficult to correct."
Dr. Longobardi, a graduate of New York University School of Medicine and member of the American Academy of Orthopaedic Surgeons and numerous other medical associations, is an Assistant Professor of Clinical Orthopaedic Surgery at NYU Medical Center and has been honored by the Lillian S. Lusskin Orthopaedic Foundation for Excellence in Teaching. He is affiliated with Hackensack Medical Center, Holy Name Hospital and New York University Medical Center and the Hospital for Joint Diseases in New York City. Dr. Longobardi has also served as Team Physician to the Florida Marlins Baseball Team, the U.S. Tennis Association, the NY/NJ MetroStars Soccer Team, the New York Islanders Hockey Team, and numerous other professional and collegiate sports teams.
University Orthopaedic Center
воскресенье, 24 апреля 2011 г.
BioMimetic Therapeutics, Inc. Closes Enrollment With 436 Patients In North American Pivotal Study For Augment™ Bone Graft
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced that as of December 31, 2008, 436 patients were enrolled in the Company's North American pivotal clinical study for its lead orthopedic product candidate Augment™ Bone Graft. Enrollment is now closed in this study to assess the safety and efficacy of Augment for the treatment of foot and ankle fusions as compared to autograft, the current gold standard for bone grafting in this type of surgery. The study was designed to enroll 396 patients, however enrollment in the trial continued through December 31 to accommodate those additional patients who had already been consented into the study and scheduled for surgery.
"A strong acceleration of enrollment in the fourth quarter enabled the completion of enrollment in December," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "We are gratified by the surgeons' commitment and confidence, and as a result, we expect to be able to file the clinical data with the FDA in the fourth quarter of this year as the last element of our modular PMA filing. The other two sections of the PMA, the pre-clinical and the quality/manufacturing sections, are on schedule to be filed this spring allowing time for the Agency to review these data in advance of the clinical data. I want to once again acknowledge the ongoing efforts of our clinical investigators for their considerable work on the study."
The North American pivotal study is designed as a randomized controlled non-inferiority trial comparing Augment to autograft, with the two treatments randomized 2:1, respectively. The primary endpoint of the study is the percent of patients fused, as measured by CT scans, at six months. Secondary endpoints include clinical assessment, plain film radiographic evaluation and several functional and pain assessments. The evaluation of all CT scans and X-rays will be done by a blinded, independent radiologist, who will assess the key parameters of radiographic fusion (bone healing).
On another important issue, the Company also announced today that the United States Patent Office issued patent number 7,473,678 entitled "Platelet-Derived Growth Factor Compositions and Methods of Use Thereof." Although the Company previously announced that this patent would expire in 2024, as part of the issuance process, a term extension was granted by the Patent Office that will provide the Company protection for its Augment product line, as well as certain other PDGF product formulations, until at least June 2025.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is developing and commercializing bio-active recombinant protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S®, as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing with its product candidates Augment and Augment Injectable in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the arm. The Company's previously approved product and lead product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.
GEM 21S® is the registered trademark of Luitpold Pharmaceuticals, Inc., who now owns and markets that product.
BioMimetic Therapeutics
"A strong acceleration of enrollment in the fourth quarter enabled the completion of enrollment in December," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "We are gratified by the surgeons' commitment and confidence, and as a result, we expect to be able to file the clinical data with the FDA in the fourth quarter of this year as the last element of our modular PMA filing. The other two sections of the PMA, the pre-clinical and the quality/manufacturing sections, are on schedule to be filed this spring allowing time for the Agency to review these data in advance of the clinical data. I want to once again acknowledge the ongoing efforts of our clinical investigators for their considerable work on the study."
The North American pivotal study is designed as a randomized controlled non-inferiority trial comparing Augment to autograft, with the two treatments randomized 2:1, respectively. The primary endpoint of the study is the percent of patients fused, as measured by CT scans, at six months. Secondary endpoints include clinical assessment, plain film radiographic evaluation and several functional and pain assessments. The evaluation of all CT scans and X-rays will be done by a blinded, independent radiologist, who will assess the key parameters of radiographic fusion (bone healing).
On another important issue, the Company also announced today that the United States Patent Office issued patent number 7,473,678 entitled "Platelet-Derived Growth Factor Compositions and Methods of Use Thereof." Although the Company previously announced that this patent would expire in 2024, as part of the issuance process, a term extension was granted by the Patent Office that will provide the Company protection for its Augment product line, as well as certain other PDGF product formulations, until at least June 2025.
About BioMimetic Therapeutics
BioMimetic Therapeutics, Inc. is developing and commercializing bio-active recombinant protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S®, as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing with its product candidates Augment and Augment Injectable in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the arm. The Company's previously approved product and lead product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.
GEM 21S® is the registered trademark of Luitpold Pharmaceuticals, Inc., who now owns and markets that product.
BioMimetic Therapeutics
TransPharma Announces Successful Results Of A Phase 1 Clinical Trial Of ViaDerm-Calcitonin For The Treatment Of Musculoskeletal Disorders
TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.
The Phase I study was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ViaDerm-Calcitonin in 12 postmenopausal women treated with 4 different transdermal Calcitonin doses (60-300 mcg) compared to 100IU of Miacalcin, the subcutaneous injected form of the Calcitonin.
Study results demonstrated a clear PK dose response corresponding to the escalating doses of the ViaDerm-Calcitonin patches. Furthermore, a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin. All doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.
Calcitonin is commercially available in subcutaneous, intramuscular and nasal routes for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget's disease. Calcitonin is a very safe drug that has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.
"We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications."
About the Self Applied ViaDerm Drug Delivery System
TransPharma's ViaDerm drug delivery system incorporates a handheld electronic device, which creates microscopic passageways through the outer layer of the skin allowing for transdermal delivery of a wide variety of drugs from a patch. The system provides a cost-effective, easy-to-use, virtually pain-free, self-administered solution that enables the safe, reproducible and accurate delivery of a broad range of product candidates, including hydrophilic small molecule such as peptides and proteins.
About Osteoarthritis
Osteoarthritis is a degenerative joint disease involving gradual degradation of joints. Symptoms may include joint pain, tenderness, stiffness, locking of the joint and swelling. When bone surfaces become less well protected by the loss of cartilage, the bone may be damaged, leading to the various Osteoarthritis symptoms, and a decreased quality of life. In severe cases the joint might need replacement surgery. Osteoarthritis is the leading cause of chronic disability, affecting nearly 27 million people and totaling $60 billion annually in related healthcare costs in the U.S. alone.
About Musculoskeletal Pain
Non-malignant musculoskeletal pain is the most common clinical symptom that causes patients to seek medical attention and is the major cause of disability in the world. Musculoskeletal pain can arise from a variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery, low back pain, and bone fracture. The musculoskeletal market is the sixth largest therapeutic category by sales.
Source:
TransPharma Medical
View drug information on Miacalcin.
The Phase I study was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ViaDerm-Calcitonin in 12 postmenopausal women treated with 4 different transdermal Calcitonin doses (60-300 mcg) compared to 100IU of Miacalcin, the subcutaneous injected form of the Calcitonin.
Study results demonstrated a clear PK dose response corresponding to the escalating doses of the ViaDerm-Calcitonin patches. Furthermore, a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin. All doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.
Calcitonin is commercially available in subcutaneous, intramuscular and nasal routes for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget's disease. Calcitonin is a very safe drug that has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.
"We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications."
About the Self Applied ViaDerm Drug Delivery System
TransPharma's ViaDerm drug delivery system incorporates a handheld electronic device, which creates microscopic passageways through the outer layer of the skin allowing for transdermal delivery of a wide variety of drugs from a patch. The system provides a cost-effective, easy-to-use, virtually pain-free, self-administered solution that enables the safe, reproducible and accurate delivery of a broad range of product candidates, including hydrophilic small molecule such as peptides and proteins.
About Osteoarthritis
Osteoarthritis is a degenerative joint disease involving gradual degradation of joints. Symptoms may include joint pain, tenderness, stiffness, locking of the joint and swelling. When bone surfaces become less well protected by the loss of cartilage, the bone may be damaged, leading to the various Osteoarthritis symptoms, and a decreased quality of life. In severe cases the joint might need replacement surgery. Osteoarthritis is the leading cause of chronic disability, affecting nearly 27 million people and totaling $60 billion annually in related healthcare costs in the U.S. alone.
About Musculoskeletal Pain
Non-malignant musculoskeletal pain is the most common clinical symptom that causes patients to seek medical attention and is the major cause of disability in the world. Musculoskeletal pain can arise from a variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery, low back pain, and bone fracture. The musculoskeletal market is the sixth largest therapeutic category by sales.
Source:
TransPharma Medical
View drug information on Miacalcin.
суббота, 23 апреля 2011 г.
Sedentary High School Girls Are At Significant Risk For Future Osteoporosis
Significant numbers of female high school athletes and non athletes suffer from one or more components of the female athlete triad, a combination of three conditions that can lead to cardiovascular disease, according to a new study by Medical College of Wisconsin researchers in Milwaukee.
The study results were presented at the American College of Sports Medicine at Indianapolis, by Anne Z. Hoch, D.O., associate professor of orthopedic surgery and physical medicine and rehabilitation at the Medical College, and director of the Froedtert & Medical College Sports Medicine Program. She is also a member of the Medical College's Cardiovascular Center.
Dr. Hoch found that 78 percent of female high school athletes and 65 percent of female high school non-athletes display one or more components of the female athlete triad. The triad is a combination of three conditions low energy availability, menstrual abnormalities and low bone mineral density that often leads to the same steroid and hormonal profiles as postmenopausal women.
"We are concerned that non athletic girls have some of the same components of the female athlete triad as athletes and are in fact at greater risk for low bone density," says Dr. Hoch. "These young women are under great pressure to conform to society's standards of body image. In an effort to lose weight, they are restricting their caloric intake and adapting unhealthy nutrition habits."
The study, conducted at Froedtert Hospital, examined eighty varsity athletes and eighty non-athletes at an all-girls school in Milwaukee. Ninety-three percent of non-athletes were found to have calcium deficiencies, compared to 74 percent of athletes.
"Most important and alarming is that 30 percent of the non athletes versus 16 percent of athletes were found to have low bone mineral density putting them at greater risk for developing osteoporosis earlier in life," says Dr. Hoch.
Both groups showed little difference in low energy availability, with 39 percent of non-athletes and 36 percent of athletes reporting this condition.
The athletes reported 33 percent more menstrual abnormalities than the non-athletes. Women who have normal periods, and hence normal estrogen levels, are less likely to display changes in the function of the layer of cells that line the interior of blood vessels, called the endothelium.
"Change in endothelial function is the seminal event in cardiovascular disease," says Dr. Hoch.
Dr. Hoch began her studies in the late 1990s to see if young women who have menstrual abnormalities as a result of participating in intense sports are likely to develop cardiovascular disease similar to that seen in postmenopausal women. She and her colleagues were able to show that young women who had the triad also had early vascular change that is a precursor to cardiovascular disease.
"We not only need to educate athletes about the consequences of the triad, now we must educate all students about the harmful effects of a restrictive diet in the adolescent period," says Dr. Hoch.
The study was funded in part by a grant from the General Clinical Research Center, which has evolved into the Clinical and Translational Science Institute; the Medical College's Cardiovascular Center; and the Steve Cullen Run and Walk.
Other Medical College researchers included Guillermo Carrere, M.D., professor of radiology; Charles Wilson, Ph.D., associate professor of radiology; David Gutterman, M.D., Northwestern Mutual Professor in Cardiology and senior associate dean for research, and Jane Schimke, clinical research coordinator in orthopedic surgery.
Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
United States
mcw
The study results were presented at the American College of Sports Medicine at Indianapolis, by Anne Z. Hoch, D.O., associate professor of orthopedic surgery and physical medicine and rehabilitation at the Medical College, and director of the Froedtert & Medical College Sports Medicine Program. She is also a member of the Medical College's Cardiovascular Center.
Dr. Hoch found that 78 percent of female high school athletes and 65 percent of female high school non-athletes display one or more components of the female athlete triad. The triad is a combination of three conditions low energy availability, menstrual abnormalities and low bone mineral density that often leads to the same steroid and hormonal profiles as postmenopausal women.
"We are concerned that non athletic girls have some of the same components of the female athlete triad as athletes and are in fact at greater risk for low bone density," says Dr. Hoch. "These young women are under great pressure to conform to society's standards of body image. In an effort to lose weight, they are restricting their caloric intake and adapting unhealthy nutrition habits."
The study, conducted at Froedtert Hospital, examined eighty varsity athletes and eighty non-athletes at an all-girls school in Milwaukee. Ninety-three percent of non-athletes were found to have calcium deficiencies, compared to 74 percent of athletes.
"Most important and alarming is that 30 percent of the non athletes versus 16 percent of athletes were found to have low bone mineral density putting them at greater risk for developing osteoporosis earlier in life," says Dr. Hoch.
Both groups showed little difference in low energy availability, with 39 percent of non-athletes and 36 percent of athletes reporting this condition.
The athletes reported 33 percent more menstrual abnormalities than the non-athletes. Women who have normal periods, and hence normal estrogen levels, are less likely to display changes in the function of the layer of cells that line the interior of blood vessels, called the endothelium.
"Change in endothelial function is the seminal event in cardiovascular disease," says Dr. Hoch.
Dr. Hoch began her studies in the late 1990s to see if young women who have menstrual abnormalities as a result of participating in intense sports are likely to develop cardiovascular disease similar to that seen in postmenopausal women. She and her colleagues were able to show that young women who had the triad also had early vascular change that is a precursor to cardiovascular disease.
"We not only need to educate athletes about the consequences of the triad, now we must educate all students about the harmful effects of a restrictive diet in the adolescent period," says Dr. Hoch.
The study was funded in part by a grant from the General Clinical Research Center, which has evolved into the Clinical and Translational Science Institute; the Medical College's Cardiovascular Center; and the Steve Cullen Run and Walk.
Other Medical College researchers included Guillermo Carrere, M.D., professor of radiology; Charles Wilson, Ph.D., associate professor of radiology; David Gutterman, M.D., Northwestern Mutual Professor in Cardiology and senior associate dean for research, and Jane Schimke, clinical research coordinator in orthopedic surgery.
Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
United States
mcw
пятница, 22 апреля 2011 г.
Daniel J. Berry, MD, Named President Of The American Academy Of Orthopaedic Surgeons
Orthopaedic surgeon Daniel J. Berry, MD, became the president of the Board of Directors of the American Academy of Orthopaedic Surgeons (AAOS) at the organization's 2011 Annual Meeting in San Diego.
"We (orthopaedic surgeons) must constantly renew our knowledge foundation with the incredible opportunities provided by almost instant access to orthopaedic information - such as the Academy's own OrthoPortal. I will look for us all to work together to seize the opportunities promised by these new communication channels to provide education and information to our members and to the public," said Dr. Berry.
Dr. Berry said he and the leaders on the AAOS Board of Directors have identified several topics of priority for the coming year, including quality initiatives, evidence-based practice initiatives, continuing a path of fiscal responsibility and finding innovative ways to refresh, reinforce and deliver learning and continuing education initiatives.
Active in the AAOS since 1998, Dr. Berry has served on numerous committees and task forces, including the American Joint Replacement Registry (AJRR) and the CME Courses Committee. He most recently served as vice president (2010) and second vice president (2009) of the Academy. He also held the position of president of the American Association of Hip and Knee Surgeons (AAHKS) and held previous leadership roles for the American Board of Orthopaedic Surgery (ABOS), the Hip Society and the Mid America Orthopaedic Association.
A graduate of Dartmouth College and Harvard Medical School, Dr. Berry completed orthopaedic surgery residencies at Harvard, Brigham and Women's Hospital and Massachusetts General Hospital. He completed his fellowship at Mayo Clinic in Rochester, Minnesota. Currently, he serves as professor of orthopaedics, College of Medicine at Mayo Clinic and chair in the Department of Orthopaedic Surgery at Mayo Clinic.
"This is a remarkable time in American medicine and together with my colleagues on the Board, we will adjust to the new demands of healthcare that insist that we demonstrate - as everyone must in this new global economy - the value and the quality of our work. In orthopaedics, we have significant data and anecdotal evidence that our work has a dramatic and positive effect on our patients' lives, but we will continue to find ways to measure the outcomes and long-term effect of our work," Berry remarked.
An orthopaedic surgeon and researcher, Dr. Berry has received numerous honors and accolades including awards for clinical research from the Hip Society, the Knee Society, the AAHKS, and the Orthopedic Research and Education Foundation (OREF). He is the author or co-author of more than 130 peer-reviewed publications and 60 book chapters. Dr. Berry has made scientific presentations at hundreds of regional, national and international meetings.
"My predecessor, John Callaghan, MD (the Academy's immediate past president) has done an excellent job as president and one of the many things he did that I admired was seek a variety of perspectives in a fair and determined effort to build organizational consensus. That is exactly what I believe this role should do for the Academy. The president should help the organization respond to the needs of the patient population and the AAOS membership in a responsible, responsive way," said Berry.
"Dan is not only one of the great researchers in orthopaedics, he also is an incredibly organized, thoughtful and considerate voice on our board. Dan's diplomacy, commitment and capacity to envision successful outcomes is extremely important to our board's collective commitment," stated John Tongue, MD, first vice president of the AAOS. "I enjoy working alongside Dan in our continued service to the membership."
When not working on Academy business, seeing patients or in the operating room, Dr. Berry enjoys the outdoors and traveling. He is an avid fly fisherman and downhill and cross country skier. He also greatly enjoys time with his wife, Camilla, and children, Charlotte and John.
Source:
American Academy of Orthopaedic Surgeons (AAOS)
"We (orthopaedic surgeons) must constantly renew our knowledge foundation with the incredible opportunities provided by almost instant access to orthopaedic information - such as the Academy's own OrthoPortal. I will look for us all to work together to seize the opportunities promised by these new communication channels to provide education and information to our members and to the public," said Dr. Berry.
Dr. Berry said he and the leaders on the AAOS Board of Directors have identified several topics of priority for the coming year, including quality initiatives, evidence-based practice initiatives, continuing a path of fiscal responsibility and finding innovative ways to refresh, reinforce and deliver learning and continuing education initiatives.
Active in the AAOS since 1998, Dr. Berry has served on numerous committees and task forces, including the American Joint Replacement Registry (AJRR) and the CME Courses Committee. He most recently served as vice president (2010) and second vice president (2009) of the Academy. He also held the position of president of the American Association of Hip and Knee Surgeons (AAHKS) and held previous leadership roles for the American Board of Orthopaedic Surgery (ABOS), the Hip Society and the Mid America Orthopaedic Association.
A graduate of Dartmouth College and Harvard Medical School, Dr. Berry completed orthopaedic surgery residencies at Harvard, Brigham and Women's Hospital and Massachusetts General Hospital. He completed his fellowship at Mayo Clinic in Rochester, Minnesota. Currently, he serves as professor of orthopaedics, College of Medicine at Mayo Clinic and chair in the Department of Orthopaedic Surgery at Mayo Clinic.
"This is a remarkable time in American medicine and together with my colleagues on the Board, we will adjust to the new demands of healthcare that insist that we demonstrate - as everyone must in this new global economy - the value and the quality of our work. In orthopaedics, we have significant data and anecdotal evidence that our work has a dramatic and positive effect on our patients' lives, but we will continue to find ways to measure the outcomes and long-term effect of our work," Berry remarked.
An orthopaedic surgeon and researcher, Dr. Berry has received numerous honors and accolades including awards for clinical research from the Hip Society, the Knee Society, the AAHKS, and the Orthopedic Research and Education Foundation (OREF). He is the author or co-author of more than 130 peer-reviewed publications and 60 book chapters. Dr. Berry has made scientific presentations at hundreds of regional, national and international meetings.
"My predecessor, John Callaghan, MD (the Academy's immediate past president) has done an excellent job as president and one of the many things he did that I admired was seek a variety of perspectives in a fair and determined effort to build organizational consensus. That is exactly what I believe this role should do for the Academy. The president should help the organization respond to the needs of the patient population and the AAOS membership in a responsible, responsive way," said Berry.
"Dan is not only one of the great researchers in orthopaedics, he also is an incredibly organized, thoughtful and considerate voice on our board. Dan's diplomacy, commitment and capacity to envision successful outcomes is extremely important to our board's collective commitment," stated John Tongue, MD, first vice president of the AAOS. "I enjoy working alongside Dan in our continued service to the membership."
When not working on Academy business, seeing patients or in the operating room, Dr. Berry enjoys the outdoors and traveling. He is an avid fly fisherman and downhill and cross country skier. He also greatly enjoys time with his wife, Camilla, and children, Charlotte and John.
Source:
American Academy of Orthopaedic Surgeons (AAOS)
четверг, 21 апреля 2011 г.
Negative Effects On Bones After Weight Loss Persist Through Weight Maintenance
When a person is losing a significant amount of weight, they expect to notice changes in their body. However, they may overlook changes happening in their bones. During weight loss through calorie-restricted diets, bones are being remodeled - breaking down old bone and forming new bone - at an accelerated rate. At the same time, bone density is decreasing, causing increased fragility. In a new study, a University of Missouri researcher and collaborators at the University of Kansas found that the potentially harmful effects of weight loss on bone persist during weight maintenance following moderate weight loss.
Researchers examined protein markers of bone breakdown and formation in 37 obese, middle-aged adults who lost 20 percent of their body weight through a severe calorie-restricted diet. Protein markers, which are released during bone breakdown and formation, are used as indirect indicators of bone remodeling. During the 3-month weight-loss phase, bone remodeling was elevated, and bone formation and breakdown were imbalanced as a result of a low energy intake. After weight loss phase, bone remodeling remained elevated during the 9-month weight maintenance phase, but bone formation and breakdown appeared to be balanced.
"When people increased their calorie intake after weight loss, the bone remodeling markers did not respond and remained above what they were before weight loss," said Pam Hinton, associate professor of nutritional sciences in the MU College of Human Environmental Sciences. "However unlike the weight loss phase, it appeared that bone breakdown and bone formation were balanced. Rapid rates of bone remodeling, regardless of the balance of breakdown and formation, can increase bone fragility."
Hinton found that a greater reduction in body weight resulted in a greater increase in bone breakdown. Having a low-carbohydrate or a low-fat diet during the weight maintenance phase had no effect on bone remodeling in the participants. Hinton also found that gender, hormone replacement therapy and menopausal status did not affect changes in bone remodeling markers and body weight. Previous studies have reported elevated bone formation and breakdown and decreased bone mass after modest weight reduction in a 6 to 12 month period, Hinton said.
"From this study alone, it is impossible to determine the consequences of accelerated bone remodeling during weight maintenance," Hinton said. "Because bone strength adapts to match skeletal load, body weight is one of the strongest predictors of bone mass. People planning on losing a significant amount of weight should consider incorporating high-impact weight-bearing physical activity into their exercise routine and consuming adequate calcium to improve bone health."
Source: Kelsey Jackson
University of Missouri-Columbia
Researchers examined protein markers of bone breakdown and formation in 37 obese, middle-aged adults who lost 20 percent of their body weight through a severe calorie-restricted diet. Protein markers, which are released during bone breakdown and formation, are used as indirect indicators of bone remodeling. During the 3-month weight-loss phase, bone remodeling was elevated, and bone formation and breakdown were imbalanced as a result of a low energy intake. After weight loss phase, bone remodeling remained elevated during the 9-month weight maintenance phase, but bone formation and breakdown appeared to be balanced.
"When people increased their calorie intake after weight loss, the bone remodeling markers did not respond and remained above what they were before weight loss," said Pam Hinton, associate professor of nutritional sciences in the MU College of Human Environmental Sciences. "However unlike the weight loss phase, it appeared that bone breakdown and bone formation were balanced. Rapid rates of bone remodeling, regardless of the balance of breakdown and formation, can increase bone fragility."
Hinton found that a greater reduction in body weight resulted in a greater increase in bone breakdown. Having a low-carbohydrate or a low-fat diet during the weight maintenance phase had no effect on bone remodeling in the participants. Hinton also found that gender, hormone replacement therapy and menopausal status did not affect changes in bone remodeling markers and body weight. Previous studies have reported elevated bone formation and breakdown and decreased bone mass after modest weight reduction in a 6 to 12 month period, Hinton said.
"From this study alone, it is impossible to determine the consequences of accelerated bone remodeling during weight maintenance," Hinton said. "Because bone strength adapts to match skeletal load, body weight is one of the strongest predictors of bone mass. People planning on losing a significant amount of weight should consider incorporating high-impact weight-bearing physical activity into their exercise routine and consuming adequate calcium to improve bone health."
Source: Kelsey Jackson
University of Missouri-Columbia
среда, 20 апреля 2011 г.
BioMarin Announces Program For BMN-111 For The Treatment Of Achondroplasia
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia. BioMarin plans to file an IND in the fourth quarter of 2011 and to initiate a Phase 1 clinical trial by the first quarter of 2012.
BMN-111, for the treatment of achondroplasia, is an analog of C-type Natriuretic Peptide (CNP), a small cyclic peptide that is a positive regulator of bone growth. It is produced and has a receptor in the growth plate, and along with the fibroblast growth factor receptor 3 (FGFR3), regulates normal bone growth. In addition to short stature, there are complications in achondroplasia that are related to bone compression (e.g. foramen magnum narrowing, spinal stenosis, upper respiratory narrowing) of nervous tissues or other tissues.
"This program is a perfect fit in our growing pipeline. It is an unmet medical need in an orphan disease population and can leverage our expertise in biologic manufacturing," said Hank Fuchs, M.D., Executive Vice President and Chief Medical Officer of BioMarin. "Proof-of-concept studies demonstrate that CNP can reverse the achondroplastic phenotype in mice. Additionally, in both mice and primates, BMN-111 was able to penetrate the growth plate and accelerate growth at hemodynamically acceptable doses. We have a proven track record of expeditiously bringing life-altering therapeutics to patients and are determined to do the same with this program. We look forward to updating you on advancements in this and other programs in our product pipeline."
Additional details of the achondroplasia program, along with an overview of BioMarin's product portfolio and advancements in the research and development pipeline will be provided today at BioMarin's R&D Day program in New York City.
About Achondroplasia
Achondroplasia is caused by an autosomal dominant activating mutation in the fibroblast growth factor receptor 3 (FGFR3) gene, a negative regulator of bone growth. Eighty percent of cases are the result of a spontaneous mutation, and ninety-eight percent of those cases have a G380R mutation. Achondroplasia is the most common form of human dwarfism and is characterized by failure of normal conversion of cartilage into bone. Clinical manifestations of the disease include short stature, craniomedullary compression, apnea, bowed legs, frontal bossing and midface hypoplasia, permanent sway of the lower back, spinal stenosis, recurrent ear infections and obesity.
The rate of incidence of achondroplasia is one in 15,000 to one in 40,000 live births, with approximately 18,000 to 24,000 patients in the U.S. and Europe combined.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of its program for achondroplasia, and expectations regarding filings with regulatory agencies. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results of current and planned clinical trials related to the peptide therapeutic for achondroplasia; the content and timing of decisions by the U.S. Food and Drug Administration and other regulatory agencies, particularly with respect to the peptide therapeutic for achondroplasia, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2009 Annual Report on Form 10- K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.
Firdapse™ is a trademark of BioMarin Huxley Ltd.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
Source: BioMarin Pharmaceutical Inc
View drug information on Aldurazyme; Kuvan; Naglazyme.
BMN-111, for the treatment of achondroplasia, is an analog of C-type Natriuretic Peptide (CNP), a small cyclic peptide that is a positive regulator of bone growth. It is produced and has a receptor in the growth plate, and along with the fibroblast growth factor receptor 3 (FGFR3), regulates normal bone growth. In addition to short stature, there are complications in achondroplasia that are related to bone compression (e.g. foramen magnum narrowing, spinal stenosis, upper respiratory narrowing) of nervous tissues or other tissues.
"This program is a perfect fit in our growing pipeline. It is an unmet medical need in an orphan disease population and can leverage our expertise in biologic manufacturing," said Hank Fuchs, M.D., Executive Vice President and Chief Medical Officer of BioMarin. "Proof-of-concept studies demonstrate that CNP can reverse the achondroplastic phenotype in mice. Additionally, in both mice and primates, BMN-111 was able to penetrate the growth plate and accelerate growth at hemodynamically acceptable doses. We have a proven track record of expeditiously bringing life-altering therapeutics to patients and are determined to do the same with this program. We look forward to updating you on advancements in this and other programs in our product pipeline."
Additional details of the achondroplasia program, along with an overview of BioMarin's product portfolio and advancements in the research and development pipeline will be provided today at BioMarin's R&D Day program in New York City.
About Achondroplasia
Achondroplasia is caused by an autosomal dominant activating mutation in the fibroblast growth factor receptor 3 (FGFR3) gene, a negative regulator of bone growth. Eighty percent of cases are the result of a spontaneous mutation, and ninety-eight percent of those cases have a G380R mutation. Achondroplasia is the most common form of human dwarfism and is characterized by failure of normal conversion of cartilage into bone. Clinical manifestations of the disease include short stature, craniomedullary compression, apnea, bowed legs, frontal bossing and midface hypoplasia, permanent sway of the lower back, spinal stenosis, recurrent ear infections and obesity.
The rate of incidence of achondroplasia is one in 15,000 to one in 40,000 live births, with approximately 18,000 to 24,000 patients in the U.S. and Europe combined.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of its program for achondroplasia, and expectations regarding filings with regulatory agencies. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the results of current and planned clinical trials related to the peptide therapeutic for achondroplasia; the content and timing of decisions by the U.S. Food and Drug Administration and other regulatory agencies, particularly with respect to the peptide therapeutic for achondroplasia, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2009 Annual Report on Form 10- K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.
Firdapse™ is a trademark of BioMarin Huxley Ltd.
Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
Source: BioMarin Pharmaceutical Inc
View drug information on Aldurazyme; Kuvan; Naglazyme.
вторник, 19 апреля 2011 г.
Latest research and emerging treatments for osteoporosis focus of NYAS conference
Recently, the US Surgeon General issued a report emphasizing the need to recognize osteoporosis as a public health
hazard. It is fortuitous that, in recent years, the use of advanced molecular technologies, including transgenesis, gene
knockout, and gene array have greatly expanded our understanding of how our bones and joints are affected by aging, health
and disease. Researchers have gained a better understanding of the precise pathways through which new and old bones are
repaired and remodeled. Clearer too are the basic biological properties of the skeleton and how it responds to hormonal,
cytokine, and mechanical stimulation.
How are these exciting new studies opening the doors to novel cellular and molecular targets for future drug development?
What are the latest and emerging therapies for osteoporosis?
To highlight the latest research on osteoporosis and the effect of health, disease and aging on skeletal development, the New
York Academy of Sciences is sponsoring a conference, Skeletal Development and Remodeling in Health, Disease and Aging on May
18-21 at the Hatch Auditorium in the Guggenheim Pavilion at The Mount Sinai Medical Center.
The conference will be divided into five broad themes:
-- skeletal development and repair
-- molecular endocrinology of bone
-- bone cell biology
-- conservation of skeletal integrity
-- current and emerging therapies for osteoporosis.
Each section will offer participants to engage in a focused discussion within each category.
The Keynote Speakers are: Harvey V. Fineberg, President of the Institute of Medicine of the National Academies; Henry
Kronenberg, Massachusetts General Hospital and Harvard Medical School; David L. Lacey, Amgen, Inc.; Bjorn Olsen, Harvard
Medical School; Dame Julia Polak, Imperial College; Graham Russell, University of Oxford; Allen M. Spiegel, NIDDK, National
Institutes of Health; and Steven L. Teitelbaum, Washington University School of Medicine Dr. Mone Zaidi, Mount Sinai School
of Medicine, New York, is Scientific Director and Program Chair of the conference.
"This conference will bring together international experts who will focus on the mechanisms underlying the genesis of
osteoporosis and help translate new research findings into novel therapeutic strategies," said Dr. Zaidi. "Research into
osteoporosis has blossomed during the last decade and this calls for a concerted effort by investigators to help disseminate
the results and create new options for future patient-related research."
The proceedings of this conference will be published in the Annals of the New York Academy of Sciences.
For a preview of the conference, visit nyas/ebriefreps/splash.asp?intEBriefID=398
Founded in 1817, the New York Academy of Science is an independent nonprofit organization of more than 22,000 members
worldwide dedicated to serving science, technology, and society.
Contact: Jennifer Tang
jtangnyas
212-838-0230 x257
New York Academy of Sciences
nyas
hazard. It is fortuitous that, in recent years, the use of advanced molecular technologies, including transgenesis, gene
knockout, and gene array have greatly expanded our understanding of how our bones and joints are affected by aging, health
and disease. Researchers have gained a better understanding of the precise pathways through which new and old bones are
repaired and remodeled. Clearer too are the basic biological properties of the skeleton and how it responds to hormonal,
cytokine, and mechanical stimulation.
How are these exciting new studies opening the doors to novel cellular and molecular targets for future drug development?
What are the latest and emerging therapies for osteoporosis?
To highlight the latest research on osteoporosis and the effect of health, disease and aging on skeletal development, the New
York Academy of Sciences is sponsoring a conference, Skeletal Development and Remodeling in Health, Disease and Aging on May
18-21 at the Hatch Auditorium in the Guggenheim Pavilion at The Mount Sinai Medical Center.
The conference will be divided into five broad themes:
-- skeletal development and repair
-- molecular endocrinology of bone
-- bone cell biology
-- conservation of skeletal integrity
-- current and emerging therapies for osteoporosis.
Each section will offer participants to engage in a focused discussion within each category.
The Keynote Speakers are: Harvey V. Fineberg, President of the Institute of Medicine of the National Academies; Henry
Kronenberg, Massachusetts General Hospital and Harvard Medical School; David L. Lacey, Amgen, Inc.; Bjorn Olsen, Harvard
Medical School; Dame Julia Polak, Imperial College; Graham Russell, University of Oxford; Allen M. Spiegel, NIDDK, National
Institutes of Health; and Steven L. Teitelbaum, Washington University School of Medicine Dr. Mone Zaidi, Mount Sinai School
of Medicine, New York, is Scientific Director and Program Chair of the conference.
"This conference will bring together international experts who will focus on the mechanisms underlying the genesis of
osteoporosis and help translate new research findings into novel therapeutic strategies," said Dr. Zaidi. "Research into
osteoporosis has blossomed during the last decade and this calls for a concerted effort by investigators to help disseminate
the results and create new options for future patient-related research."
The proceedings of this conference will be published in the Annals of the New York Academy of Sciences.
For a preview of the conference, visit nyas/ebriefreps/splash.asp?intEBriefID=398
Founded in 1817, the New York Academy of Science is an independent nonprofit organization of more than 22,000 members
worldwide dedicated to serving science, technology, and society.
Contact: Jennifer Tang
jtangnyas
212-838-0230 x257
New York Academy of Sciences
nyas
понедельник, 18 апреля 2011 г.
News From The Journal Of Clinical Investigation: Nov. 8, 2010
ONCOLOGY: An Enigma for tumor suppression
One of the most well studied suppressors of tumor formation and development is the protein p53. A team of researchers, led by Dong-Soo Im, at the Korea Research Institute of Bioscience and Biotechnology, South Korea, has now provided new insight into how levels of this protein are regulated in human cell lines. Specifically, the team identified a mechanism by which the protein Enigma promotes p53 degradation. Among the several lines of evidence that this mechanism has a role in tumor development and progression was the observation that Enigma promoted human cancer cell line survival and resistance to chemotherapy by suppressing p53-induced cell death in a mouse xenograft model. The authors therefore suggest that Enigma could be new therapeutic target for selective activation of the tumor suppressor p53.
TITLE: Enigma negatively regulates p53 through MDM2 and promotes tumor cell survival in mice
DERMATOLOGY: Improving wound healing in diabetes
Individuals with diabetes are at increased risk of wounds not healing properly, and this leads to over 72,000 amputations each year. Impaired generation of new blood vessels at the wound site is a key factor behind poor wound healing in these patients. This in turn is in part because cells responsible for making new blood vessel-lining cells (endothelial progenitor cells) are functionally impaired. A team of researchers, led by Alex Chen, at the University of Pittsburgh School of Medicine, Pittsburgh, has now identified a reason why endothelial progenitor cells are defective in diabetic mice.
In the study, endothelial progenitor cells were found to express decreased levels of the protein manganese superoxide dismutase and this reduced their ability to contribute to new blood vessel generation, thereby impairing wound healing. Importantly, gene therapy to replace manganese superoxide dismutase in endothelial progenitor cells from diabetic mice improved their wound healing functionality. The authors therefore suggest that a similar gene therapy approach may be of benefit to patients with diabetes.
TITLE: Manganese superoxide dismutase expression in endothelial progenitor cells accelerates wound healing in diabetic mice
MUSCLE BIOLOGY: A complement to muscle wasting
Individuals with mutations in their dysferlin gene develop one of a group of muscle-wasting diseases sometimes referred to as dysferlinopathies. The exact mechanism(s) underlying the muscle wasting in these individuals is not completely understood. Now, a team of researchers, led by Kevin Campbell, at The University of Iowa, Iowa City, has identified a role for a component of the immune system that is involved in promoting inflammation (specifically, the complement system) in the muscle disease experienced by mice that lack dysferlin and thereby model dysferlinopathies. Among the several lines of evidence generated to support this conclusion was the observation that genetic manipulation of dysferlin-deficient mice such that the lacked the central complement protein C3 ameliorated the muscle wasting observed in dysferlin-deficient mice. These data lead the authors to suggest that targeting the complement system might provide a way to treat dysferlinopathies.
TITLE: Genetic ablation of complement C3 attenuates muscle pathology in dysferlin-deficient mice
PULMONARY BIOLOGY: Explaining a key aspect of an inherited lung disease
Some individuals inherit a defect in production of the protein alpha-1 antitrypsin (AAT). This causes a chronic lung disease that is characterized by excessive numbers of immune cells known as neutrophils in the lungs. A team of researchers, led by Emer Reeves, at the Royal College of Surgeons in Ireland, has now identified two mechanisms explaining why human neutrophils accumulate in the lungs of individuals with an AAT deficiency, something previously unknown. Of clinical interest, AAT augmentation therapy counteracted these mechanisms, providing insight into why it works to reduce the lung disease associated with AAT deficiency.
TITLE: alpha-1 Antitrypsin regulates human neutrophil chemotaxis induced by soluble immune complexes and IL-8
HEMATOLOGY: Rescuing red blood cell production after a bone marrow transplant
Bone marrow transplantation is used to treat some forms of cancer and some other diseases that affect blood cells. One complication after a bone marrow transplant is anemia, i.e., low levels of red blood cells. Robert Paulson and colleagues, at Pennsylvania State University, University Park, have now identified a pathway responsible for the production of new red blood cells shortly after bone marrow transplantation in mice. Specifically, they find that signaling initiated by the protein BMP4 promotes the development of red blood cell precursors in the spleen. These cells act to produce red blood cells in the immediate aftermath of bone marrow transplantation and function until the bone marrow transplant has taken hold and can take over the job of generating red blood cells. The authors point out that it might be possible to promote red blood cell production by targeting the BMP4 signaling pathway but that it will be necessary to determine whether or not this pathway functions in humans before its real clinical impact is known.
TITLE: Murine erythroid short-term radioprotection requires a BMP4-dependent, self-renewing population of stress erythroid progenitors
Source:
Karen Honey
Journal of Clinical Investigation
One of the most well studied suppressors of tumor formation and development is the protein p53. A team of researchers, led by Dong-Soo Im, at the Korea Research Institute of Bioscience and Biotechnology, South Korea, has now provided new insight into how levels of this protein are regulated in human cell lines. Specifically, the team identified a mechanism by which the protein Enigma promotes p53 degradation. Among the several lines of evidence that this mechanism has a role in tumor development and progression was the observation that Enigma promoted human cancer cell line survival and resistance to chemotherapy by suppressing p53-induced cell death in a mouse xenograft model. The authors therefore suggest that Enigma could be new therapeutic target for selective activation of the tumor suppressor p53.
TITLE: Enigma negatively regulates p53 through MDM2 and promotes tumor cell survival in mice
DERMATOLOGY: Improving wound healing in diabetes
Individuals with diabetes are at increased risk of wounds not healing properly, and this leads to over 72,000 amputations each year. Impaired generation of new blood vessels at the wound site is a key factor behind poor wound healing in these patients. This in turn is in part because cells responsible for making new blood vessel-lining cells (endothelial progenitor cells) are functionally impaired. A team of researchers, led by Alex Chen, at the University of Pittsburgh School of Medicine, Pittsburgh, has now identified a reason why endothelial progenitor cells are defective in diabetic mice.
In the study, endothelial progenitor cells were found to express decreased levels of the protein manganese superoxide dismutase and this reduced their ability to contribute to new blood vessel generation, thereby impairing wound healing. Importantly, gene therapy to replace manganese superoxide dismutase in endothelial progenitor cells from diabetic mice improved their wound healing functionality. The authors therefore suggest that a similar gene therapy approach may be of benefit to patients with diabetes.
TITLE: Manganese superoxide dismutase expression in endothelial progenitor cells accelerates wound healing in diabetic mice
MUSCLE BIOLOGY: A complement to muscle wasting
Individuals with mutations in their dysferlin gene develop one of a group of muscle-wasting diseases sometimes referred to as dysferlinopathies. The exact mechanism(s) underlying the muscle wasting in these individuals is not completely understood. Now, a team of researchers, led by Kevin Campbell, at The University of Iowa, Iowa City, has identified a role for a component of the immune system that is involved in promoting inflammation (specifically, the complement system) in the muscle disease experienced by mice that lack dysferlin and thereby model dysferlinopathies. Among the several lines of evidence generated to support this conclusion was the observation that genetic manipulation of dysferlin-deficient mice such that the lacked the central complement protein C3 ameliorated the muscle wasting observed in dysferlin-deficient mice. These data lead the authors to suggest that targeting the complement system might provide a way to treat dysferlinopathies.
TITLE: Genetic ablation of complement C3 attenuates muscle pathology in dysferlin-deficient mice
PULMONARY BIOLOGY: Explaining a key aspect of an inherited lung disease
Some individuals inherit a defect in production of the protein alpha-1 antitrypsin (AAT). This causes a chronic lung disease that is characterized by excessive numbers of immune cells known as neutrophils in the lungs. A team of researchers, led by Emer Reeves, at the Royal College of Surgeons in Ireland, has now identified two mechanisms explaining why human neutrophils accumulate in the lungs of individuals with an AAT deficiency, something previously unknown. Of clinical interest, AAT augmentation therapy counteracted these mechanisms, providing insight into why it works to reduce the lung disease associated with AAT deficiency.
TITLE: alpha-1 Antitrypsin regulates human neutrophil chemotaxis induced by soluble immune complexes and IL-8
HEMATOLOGY: Rescuing red blood cell production after a bone marrow transplant
Bone marrow transplantation is used to treat some forms of cancer and some other diseases that affect blood cells. One complication after a bone marrow transplant is anemia, i.e., low levels of red blood cells. Robert Paulson and colleagues, at Pennsylvania State University, University Park, have now identified a pathway responsible for the production of new red blood cells shortly after bone marrow transplantation in mice. Specifically, they find that signaling initiated by the protein BMP4 promotes the development of red blood cell precursors in the spleen. These cells act to produce red blood cells in the immediate aftermath of bone marrow transplantation and function until the bone marrow transplant has taken hold and can take over the job of generating red blood cells. The authors point out that it might be possible to promote red blood cell production by targeting the BMP4 signaling pathway but that it will be necessary to determine whether or not this pathway functions in humans before its real clinical impact is known.
TITLE: Murine erythroid short-term radioprotection requires a BMP4-dependent, self-renewing population of stress erythroid progenitors
Source:
Karen Honey
Journal of Clinical Investigation
воскресенье, 17 апреля 2011 г.
Foot Pain As A Result Of Gardening, By Board-Certified Podiatrist
Many gardeners will experience foot pain this season as a result of overlooking the needs of their feet. But a few minutes of preparation and good common sense can keep gardeners comfortable all season.
"Gardening is an exertive weight-bearing activity and should be considered a sport rather than a passive hobby," said Dr. Paul R. Kasdan, a board-certified podiatrist and medical director for OurHealthNetwork. "As with any sport, one should make sure to wear appropriate foot gear, and to properly stretch before engaging in the activity."
During weight-bearing activities or sports, the feet play an important role in supporting weight, balancing stance to reduce falls, and movement. They also act as shock absorbers. Foot problems commonly associated with weight-bearing activities like gardening are usually due to wearing inappropriate footgear, or the lack of proper warm-up exercises.
"To always be pain-free, the feet must be encased in the proper shoes and socks. If the shoes do not provide proper support and cushioning, then the feet lose efficiency and problems eventually occur," Dr. Kasdan said.
Here are a few of Dr. Kasdan's shoe and sock recommendations:
- A rounded-toe shoe with a deep toe box helps prevent pain due to corns and bunions, ripped and black toenails, toe blisters, and ingrown toenails.
- soles prevent bruises when stepping on stones, and they provide good shock absorption for the entire body.
- Loose socks with mild elastic compression at the top will ensure good circulation to the feet.
- Socks made of a lycra and cotton blend are very efficient at keeping the feet cool and wicking sweat off the feet.
Before doing any work in the garden, take a few minutes to stretch your feet. Get ready for physical exertion!
Dr. Kasdan recommends two exercises:
1. Lunge exercise to stretch the Achilles Tendon: Facing a wall, stand about three feet out and lean onto the surface with arms shoulder-width apart. Keeping your back straight, move your right foot toward the wall until it is about one-and-one-half feet away. With your left foot straight, bend the right foot until you feel a stretch in the Achilles Tendon. Hold this position for 15 seconds and repeat with other leg. Repeat several times.
2. Ankle rotation: Sitting on a chair, extend your right foot and rotate your toes toward you. Hold for five seconds. Then to the right, down and to the left, holding each position for five seconds. Rotate your ankle in a complete circle. Do this for one to two minutes with each foot.
"We recommend this warm-up routine for our patients that garden and have found it to be effective in preventing symptoms associated with 'out of shape' feet," Dr. Kasdan said.
Gardeners are also encouraged to give their feet attention at the end of the day. To prevent additional foot problems, Dr. Kasdan advises his patients to wash their feet well and examine them for blisters, sores and inflamed areas. Should these conditions arise, treat them immediately with first-aid cream, or see a podiatrist. More information about these conditions and more than 50 other conditions that commonly affect the feet and ankles is available at OurHealthNetwork.
Also, remove the inner-soles of shoes and let them dry out. With more than 250,000 sweat glands in each foot, feet are among the most perspiring parts of the body. In one day, the feet can produce more than a pint of sweat.
Foot Problems which May Be Associated with Gardening:
Bruised toenails and ingrown toenails may be due to:
1. stubbing a toe or dropping a heavy object on it.
2. wearing a shoe that is too short.
3. wearing a shoe with a shallow or narrow toe box (the area where the toes sit in a shoe is called the toe box). When the toe box is too shallow or too narrow, the toenail/toenails will rub against the top or sides of the toe box, and may become bruised or ingrown.
4. cutting the toenails too short or rounded may produce ingrown toenails (the nails should be cut straight across, and always let them be a comfortable length).
5. kneeling for long periods of time will put abnormal pressure on the toes and toenails; this may cause bruising.
6. socks act as a cushion and reduce friction on the toes and feet. Not wearing socks allows the toenails to be exposed to unnecessary friction; this may cause bruising.
Swelling may be due to:
1. gravity is the most common cause of swelling of the feet and ankles. When the legs are in a dependent position (standing or sitting), gravity pulls blood and our lymph fluids down to our feet and ankles. This swelling can be reduced with the use of compression or support stockings.
2. socks which have elastic on the ankles may cause swelling by restricting the normal flow of blood and lymph fluids.
3. uncontrolled high blood pressure.
4. high heat and humidity. If you are working in this type of climate, then take frequent "cooling breaks," and sit with your legs elevated.
5. too much salt can cause water retention and swelling of the feet and ankles.
Foot and toe cramps may be caused by:
1. kneeling for long periods of time. This may reduce circulation to the feet and toes by constricting blood vessels, causing muscles to become oxygen starved, and this leads to cramps (muscle spasms). Getting up frequently and walking will help to prevent this.
2. socks and shoes that are too constrictive may cause cramps for the same reason. Make sure that the elastic on your socks is not too constrictive. Make sure that shoes are the right size.
3. being "out of shape" and stressing leg and foot muscles for long periods of time may cause cramps. Gardening is exertive. Build-up the time you spend gardening gradually, and stretch your legs often.
Throbbing and aching feet may be caused by:
1. too much weight-bearing activity for you, either due to physical problems (overweight, age, illness, etc.) or "being out of shape."
2. worn down shoes, or shoes that do not fit properly.
3. foot pathology such as bunions, hammertoes, heel spurs, etc.
More information about these conditions and more than 50 other conditions that commonly affect the feet and ankles is available at OurHealthNetwork.
OurHealthNetwork
"Gardening is an exertive weight-bearing activity and should be considered a sport rather than a passive hobby," said Dr. Paul R. Kasdan, a board-certified podiatrist and medical director for OurHealthNetwork. "As with any sport, one should make sure to wear appropriate foot gear, and to properly stretch before engaging in the activity."
During weight-bearing activities or sports, the feet play an important role in supporting weight, balancing stance to reduce falls, and movement. They also act as shock absorbers. Foot problems commonly associated with weight-bearing activities like gardening are usually due to wearing inappropriate footgear, or the lack of proper warm-up exercises.
"To always be pain-free, the feet must be encased in the proper shoes and socks. If the shoes do not provide proper support and cushioning, then the feet lose efficiency and problems eventually occur," Dr. Kasdan said.
Here are a few of Dr. Kasdan's shoe and sock recommendations:
- A rounded-toe shoe with a deep toe box helps prevent pain due to corns and bunions, ripped and black toenails, toe blisters, and ingrown toenails.
- soles prevent bruises when stepping on stones, and they provide good shock absorption for the entire body.
- Loose socks with mild elastic compression at the top will ensure good circulation to the feet.
- Socks made of a lycra and cotton blend are very efficient at keeping the feet cool and wicking sweat off the feet.
Before doing any work in the garden, take a few minutes to stretch your feet. Get ready for physical exertion!
Dr. Kasdan recommends two exercises:
1. Lunge exercise to stretch the Achilles Tendon: Facing a wall, stand about three feet out and lean onto the surface with arms shoulder-width apart. Keeping your back straight, move your right foot toward the wall until it is about one-and-one-half feet away. With your left foot straight, bend the right foot until you feel a stretch in the Achilles Tendon. Hold this position for 15 seconds and repeat with other leg. Repeat several times.
2. Ankle rotation: Sitting on a chair, extend your right foot and rotate your toes toward you. Hold for five seconds. Then to the right, down and to the left, holding each position for five seconds. Rotate your ankle in a complete circle. Do this for one to two minutes with each foot.
"We recommend this warm-up routine for our patients that garden and have found it to be effective in preventing symptoms associated with 'out of shape' feet," Dr. Kasdan said.
Gardeners are also encouraged to give their feet attention at the end of the day. To prevent additional foot problems, Dr. Kasdan advises his patients to wash their feet well and examine them for blisters, sores and inflamed areas. Should these conditions arise, treat them immediately with first-aid cream, or see a podiatrist. More information about these conditions and more than 50 other conditions that commonly affect the feet and ankles is available at OurHealthNetwork.
Also, remove the inner-soles of shoes and let them dry out. With more than 250,000 sweat glands in each foot, feet are among the most perspiring parts of the body. In one day, the feet can produce more than a pint of sweat.
Foot Problems which May Be Associated with Gardening:
Bruised toenails and ingrown toenails may be due to:
1. stubbing a toe or dropping a heavy object on it.
2. wearing a shoe that is too short.
3. wearing a shoe with a shallow or narrow toe box (the area where the toes sit in a shoe is called the toe box). When the toe box is too shallow or too narrow, the toenail/toenails will rub against the top or sides of the toe box, and may become bruised or ingrown.
4. cutting the toenails too short or rounded may produce ingrown toenails (the nails should be cut straight across, and always let them be a comfortable length).
5. kneeling for long periods of time will put abnormal pressure on the toes and toenails; this may cause bruising.
6. socks act as a cushion and reduce friction on the toes and feet. Not wearing socks allows the toenails to be exposed to unnecessary friction; this may cause bruising.
Swelling may be due to:
1. gravity is the most common cause of swelling of the feet and ankles. When the legs are in a dependent position (standing or sitting), gravity pulls blood and our lymph fluids down to our feet and ankles. This swelling can be reduced with the use of compression or support stockings.
2. socks which have elastic on the ankles may cause swelling by restricting the normal flow of blood and lymph fluids.
3. uncontrolled high blood pressure.
4. high heat and humidity. If you are working in this type of climate, then take frequent "cooling breaks," and sit with your legs elevated.
5. too much salt can cause water retention and swelling of the feet and ankles.
Foot and toe cramps may be caused by:
1. kneeling for long periods of time. This may reduce circulation to the feet and toes by constricting blood vessels, causing muscles to become oxygen starved, and this leads to cramps (muscle spasms). Getting up frequently and walking will help to prevent this.
2. socks and shoes that are too constrictive may cause cramps for the same reason. Make sure that the elastic on your socks is not too constrictive. Make sure that shoes are the right size.
3. being "out of shape" and stressing leg and foot muscles for long periods of time may cause cramps. Gardening is exertive. Build-up the time you spend gardening gradually, and stretch your legs often.
Throbbing and aching feet may be caused by:
1. too much weight-bearing activity for you, either due to physical problems (overweight, age, illness, etc.) or "being out of shape."
2. worn down shoes, or shoes that do not fit properly.
3. foot pathology such as bunions, hammertoes, heel spurs, etc.
More information about these conditions and more than 50 other conditions that commonly affect the feet and ankles is available at OurHealthNetwork.
OurHealthNetwork
суббота, 16 апреля 2011 г.
World's Largest Clinical Trial Into Rare Bone Cancer 'Well Underway' Conference Hears
The world’s largest study aimed at improving the treatment of a rare type of bone cancer that mainly affects children and young adults is well underway, an international conference was told.
The EURAMOS clinical trial, which involves a collaboration across 11 European countries, as well as the US and Canada, is on course to recruit some 1400 patients over the next few years to improve treatment for osteosarcoma, the most common bone cancer in children.
Doctors and scientists meeting at a conference in Stuttgart, Germany last week (30 November-2 December 2006) heard that recruitment for the trial was on track, with some 335 patients so far being treated within the trial.
The conference, вЂ˜Pan European Sarcoma Trials’ moving forward in a climate of increasing economic and regulatory pressure’, represented a unique gathering of experts in the field of the type of cancer called sarcomas.
Professor Stefan Bielack, the co-ordinator of the EURAMOS trial, told the meeting, “While sarcomas are rare, accounting for less than one per cent of all cancers, they are some of the most frequent that occur in childhood and adolescence. Treatment is complex and collaboration between many centres and different countries is crucial.”
The EURAMOS study brings together three existing European collaborations that are examining treatments for sarcomas, and one North American group. EURAMOS - an acronym for the European and American Osteosarcoma Study Group - is being funded through the European Science Foundation’s EUROCORES (European Collaborative Research) programme on pan-European Clinical Trials (ECT).
People with osteosarcoma are usually first given chemotherapy before the tumour is surgically removed, followed by another course of chemotherapy. The effect of the initial course of chemotherapy can vary however; in some cases there is a good response and in others a poor response. This can have a bearing on the ultimate outcome of the treatment, with poor responders to the initial course of chemotherapy tending to have a worse chance of surviving the disease. The EURAMOS trial will examine a different treatment regime for вЂ˜poor responders’ to see if survival rates can be improved.
The Stuttgart conference, attended by nearly 200 delegates from across the world, heard that new regulations governing clinical trials, introduced by the European Union, had caused difficulties but in the case of EURAMOS these hurdles had successfully been cleared. The clinical trials directive introduced by the EU and aimed at harmonising administrative provisions governing clinical trials across the Union and introducing greater protection for patients had unwittingly created a number of obstacles to establishing non-commercial clinical trials.
“Unfortunately the type of trials that we undertake to improve therapies using existing drugs now fall under the same regulations as trials by the pharmaceutical industry investigating novel agents,” said Professor Bielack. “This has created many legal and bureaucratic difficulties, especially in setting up trials across national boundaries. It has also made trials far more expensive than in the past.”
Dr Kathy Pritchard-Jones, President-elect of SIOP Europe, the European branch of the International Society of Paediatric Oncology, said, “The aims of the EU’s clinical trials directive are entirely laudable, but there have been unforeseen consequences that have led to delays in establishing trials. And while there is no doubt that clinical trials are now better constructed under the new regime, we do need a more rational approach to a number of aspects of non-commercial clinical trials.”
Dr Heribert Jürgens, immediate past-president of the German Society for Paediatric Oncology and Haematology, told the conference, “The EU regulations were designed to promote better research and protect the subjects. We have to accept and apply them, and establish centralised structures and standardised procedures.”
The issue of the use of medicines in paediatric clinical trials was also discussed. Professor Paolo Paolucci, chairman of the Therapeutic Expert Group in Oncology of the Taskforce in Europe for Drug Development for the Young (TEDDY), said, “The objectives of the EU directive are important to increase development of medicines in children.” TEDDY’s role is to promote the availability of safe and effective medicines for children in Europe by integrating existing expertise and good practice. As a вЂ˜network of excellence’ it has more than 100 doctors and scientists with an interest in sarcomas, Professor Paolucci said.
The conference also heard of many new advances in the diagnosis and treatment of sarcomas, from molecular genetic techniques to determine precisely which type of cancer was present, to the latest radiotherapy technologies and new methods for removing secondary tumours from the lung with lasers. The conference was also told how as survival rates for sarcomas continue to improve, issues of quality of life of patients are becoming increasingly important, while remaining challenging to quantify precisely and objectively.
Dr Mariana Resnicoff, co-ordinator of the ESF EUROCORES programme in medical sciences, said that the conference had demonstrated the importance of pan-European collaborations in academic trials aimed at developing new modalities in the treatment of sarcoma. Dr Resnicoff added, “EURAMOS has succeeded in overcoming the hurdles imposed by the implementation of the EU Clinical Trials Directive and the experience gathered throughout the launch of this trial can be used as a model to pave the way for further pan-European academic clinical trials in the future.”
The European Science Foundation (ESF) provides a platform for its Member Organisations to advance European research and explore new directions for research at the European level. Established in 1974 as an independent non-governmental organisation, the ESF currently serves 78 Member Organisations across 30 countries.
The European Science Foundation
The EURAMOS clinical trial, which involves a collaboration across 11 European countries, as well as the US and Canada, is on course to recruit some 1400 patients over the next few years to improve treatment for osteosarcoma, the most common bone cancer in children.
Doctors and scientists meeting at a conference in Stuttgart, Germany last week (30 November-2 December 2006) heard that recruitment for the trial was on track, with some 335 patients so far being treated within the trial.
The conference, вЂ˜Pan European Sarcoma Trials’ moving forward in a climate of increasing economic and regulatory pressure’, represented a unique gathering of experts in the field of the type of cancer called sarcomas.
Professor Stefan Bielack, the co-ordinator of the EURAMOS trial, told the meeting, “While sarcomas are rare, accounting for less than one per cent of all cancers, they are some of the most frequent that occur in childhood and adolescence. Treatment is complex and collaboration between many centres and different countries is crucial.”
The EURAMOS study brings together three existing European collaborations that are examining treatments for sarcomas, and one North American group. EURAMOS - an acronym for the European and American Osteosarcoma Study Group - is being funded through the European Science Foundation’s EUROCORES (European Collaborative Research) programme on pan-European Clinical Trials (ECT).
People with osteosarcoma are usually first given chemotherapy before the tumour is surgically removed, followed by another course of chemotherapy. The effect of the initial course of chemotherapy can vary however; in some cases there is a good response and in others a poor response. This can have a bearing on the ultimate outcome of the treatment, with poor responders to the initial course of chemotherapy tending to have a worse chance of surviving the disease. The EURAMOS trial will examine a different treatment regime for вЂ˜poor responders’ to see if survival rates can be improved.
The Stuttgart conference, attended by nearly 200 delegates from across the world, heard that new regulations governing clinical trials, introduced by the European Union, had caused difficulties but in the case of EURAMOS these hurdles had successfully been cleared. The clinical trials directive introduced by the EU and aimed at harmonising administrative provisions governing clinical trials across the Union and introducing greater protection for patients had unwittingly created a number of obstacles to establishing non-commercial clinical trials.
“Unfortunately the type of trials that we undertake to improve therapies using existing drugs now fall under the same regulations as trials by the pharmaceutical industry investigating novel agents,” said Professor Bielack. “This has created many legal and bureaucratic difficulties, especially in setting up trials across national boundaries. It has also made trials far more expensive than in the past.”
Dr Kathy Pritchard-Jones, President-elect of SIOP Europe, the European branch of the International Society of Paediatric Oncology, said, “The aims of the EU’s clinical trials directive are entirely laudable, but there have been unforeseen consequences that have led to delays in establishing trials. And while there is no doubt that clinical trials are now better constructed under the new regime, we do need a more rational approach to a number of aspects of non-commercial clinical trials.”
Dr Heribert Jürgens, immediate past-president of the German Society for Paediatric Oncology and Haematology, told the conference, “The EU regulations were designed to promote better research and protect the subjects. We have to accept and apply them, and establish centralised structures and standardised procedures.”
The issue of the use of medicines in paediatric clinical trials was also discussed. Professor Paolo Paolucci, chairman of the Therapeutic Expert Group in Oncology of the Taskforce in Europe for Drug Development for the Young (TEDDY), said, “The objectives of the EU directive are important to increase development of medicines in children.” TEDDY’s role is to promote the availability of safe and effective medicines for children in Europe by integrating existing expertise and good practice. As a вЂ˜network of excellence’ it has more than 100 doctors and scientists with an interest in sarcomas, Professor Paolucci said.
The conference also heard of many new advances in the diagnosis and treatment of sarcomas, from molecular genetic techniques to determine precisely which type of cancer was present, to the latest radiotherapy technologies and new methods for removing secondary tumours from the lung with lasers. The conference was also told how as survival rates for sarcomas continue to improve, issues of quality of life of patients are becoming increasingly important, while remaining challenging to quantify precisely and objectively.
Dr Mariana Resnicoff, co-ordinator of the ESF EUROCORES programme in medical sciences, said that the conference had demonstrated the importance of pan-European collaborations in academic trials aimed at developing new modalities in the treatment of sarcoma. Dr Resnicoff added, “EURAMOS has succeeded in overcoming the hurdles imposed by the implementation of the EU Clinical Trials Directive and the experience gathered throughout the launch of this trial can be used as a model to pave the way for further pan-European academic clinical trials in the future.”
The European Science Foundation (ESF) provides a platform for its Member Organisations to advance European research and explore new directions for research at the European level. Established in 1974 as an independent non-governmental organisation, the ESF currently serves 78 Member Organisations across 30 countries.
The European Science Foundation
Judicial Review On NICE Guidance For The Primary And Secondary Prevention Of Postmenopausal Osteoporosis (TAG 160 And 161)
Following the announcement by the High Court that NICE must reconsider the current TAG 160 and 161 for the primary and secondary prevention of postmenopausal osteoporosis (following the appeal by Servier Laboratories), Procter & Gamble Pharmaceuticals (P&GP) issue the following statement.
Within the scope of its guidance (TAG 160 and 161), which, following the outcome of the judicial review, will now be reconsidered but will not necessarily change, NICE recommended a range of treatment options. These were: alendronate first line, risedronate and etidronate as the first alternative treatment options, followed by strontium ranelate, raloxifene and teriparatide (secondary prevention only) by taking into consideration both the clinical efficacy and the acquisition costs of the treatmentsi.
P&GP welcomed the recommendation of risedronate as one of the first alternative treatment options to generic alendronate, given its proven fracture protection at all key osteoporotic sitesii,iii,iv,v,vi and favourable tolerability profile for postmenopausal osteoporosis patients who are intolerant to alendronatevii. TAGs 160 and 161 remain in force until they are confirmed or revised.
P&GP also acknowledge the concerns with the NICE TAG 160 and 161 due to the complexity of its clinical implementation. The High Court has announced that the guidance should be reviewed as a result of the cost economic data on which the guidance was based, not being shared transparently amongst stakeholders.
A pragmatic approach to prescribing based on individual patient needs is required. By balancing the overall proven efficacy profiles of the drugs with their proven cost effectiveness, the treatment pathways recommended in the NICE TAGs can still be useful until such time as this guidance is confirmed or revised.
Oral bisphosphonate treatments are the most used pharmacological intervention for osteoporosis, with alendronate and risedronate as the most commonly prescribed treatments in the UKviii. There are differences between oral bisphosphonates, such as chemical structure, tolerability profiles and proven fracture protection efficacy at vertebral, hip and other non-vertebral sites that need to be considered when making prescribing choicesix.
About Procter & Gamble Pharmaceuticals [NYSE:PG]
Procter & Gamble Pharmaceuticals has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late-1960s.
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Crest®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®, Vicks®, Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®, Fairy®, Ace®, Lenor®, M. Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®, Eukanuba®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit pg for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit pgpharma
Forward Looking Statements
For P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are based on financial data, market assumptions and business plans available only as of the time the statements are made, which may become out of date or incomplete. We assume no obligation to update any forward-looking statement as a result of new information, future events or other factors. Forward-looking statements are inherently uncertain, and investors must recognize that events could differ significantly from our expectations. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the Company has chosen to focus; (2) the ability to successfully execute, manage and integrate key acquisitions and mergers, including (i) the Domination and Profit Transfer Agreement with Wella, and (ii) the Company's merger with The Gillette Company, and to achieve the cost and growth synergies in accordance with the stated goals of these transactions; (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability, patent, and intellectual property matters as well as those related to the integration of Gillette and its subsidiaries), and to resolve pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the Company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), debt, interest rate and commodity cost exposures; (8) the ability to manage continued global political and/or economic uncertainty and disruptions, especially in the Company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage competitive factors, including prices, promotional incentives and trade terms for products; (10) the ability to obtain patents and respond to technological advances attained by competitors and patents granted to competitors; (11) the ability to successfully manage increases in the prices of raw materials used to make the Company's products; (12) the ability to stay close to consumers in an era of increased media fragmentation; and (13) the ability to stay on the leading edge of innovation and maintain a positive reputation on our brands. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Procter & Gamble Pharmaceuticals
View drug information on Actonel; Asacol.
Within the scope of its guidance (TAG 160 and 161), which, following the outcome of the judicial review, will now be reconsidered but will not necessarily change, NICE recommended a range of treatment options. These were: alendronate first line, risedronate and etidronate as the first alternative treatment options, followed by strontium ranelate, raloxifene and teriparatide (secondary prevention only) by taking into consideration both the clinical efficacy and the acquisition costs of the treatmentsi.
P&GP welcomed the recommendation of risedronate as one of the first alternative treatment options to generic alendronate, given its proven fracture protection at all key osteoporotic sitesii,iii,iv,v,vi and favourable tolerability profile for postmenopausal osteoporosis patients who are intolerant to alendronatevii. TAGs 160 and 161 remain in force until they are confirmed or revised.
P&GP also acknowledge the concerns with the NICE TAG 160 and 161 due to the complexity of its clinical implementation. The High Court has announced that the guidance should be reviewed as a result of the cost economic data on which the guidance was based, not being shared transparently amongst stakeholders.
A pragmatic approach to prescribing based on individual patient needs is required. By balancing the overall proven efficacy profiles of the drugs with their proven cost effectiveness, the treatment pathways recommended in the NICE TAGs can still be useful until such time as this guidance is confirmed or revised.
Oral bisphosphonate treatments are the most used pharmacological intervention for osteoporosis, with alendronate and risedronate as the most commonly prescribed treatments in the UKviii. There are differences between oral bisphosphonates, such as chemical structure, tolerability profiles and proven fracture protection efficacy at vertebral, hip and other non-vertebral sites that need to be considered when making prescribing choicesix.
About Procter & Gamble Pharmaceuticals [NYSE:PG]
Procter & Gamble Pharmaceuticals has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late-1960s.
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Crest®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®, Vicks®, Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®, Fairy®, Ace®, Lenor®, M. Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®, Eukanuba®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit pg for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit pgpharma
Forward Looking Statements
For P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are based on financial data, market assumptions and business plans available only as of the time the statements are made, which may become out of date or incomplete. We assume no obligation to update any forward-looking statement as a result of new information, future events or other factors. Forward-looking statements are inherently uncertain, and investors must recognize that events could differ significantly from our expectations. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the Company has chosen to focus; (2) the ability to successfully execute, manage and integrate key acquisitions and mergers, including (i) the Domination and Profit Transfer Agreement with Wella, and (ii) the Company's merger with The Gillette Company, and to achieve the cost and growth synergies in accordance with the stated goals of these transactions; (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability, patent, and intellectual property matters as well as those related to the integration of Gillette and its subsidiaries), and to resolve pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the Company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), debt, interest rate and commodity cost exposures; (8) the ability to manage continued global political and/or economic uncertainty and disruptions, especially in the Company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage competitive factors, including prices, promotional incentives and trade terms for products; (10) the ability to obtain patents and respond to technological advances attained by competitors and patents granted to competitors; (11) the ability to successfully manage increases in the prices of raw materials used to make the Company's products; (12) the ability to stay close to consumers in an era of increased media fragmentation; and (13) the ability to stay on the leading edge of innovation and maintain a positive reputation on our brands. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Procter & Gamble Pharmaceuticals
View drug information on Actonel; Asacol.
Spinal Cord Injury More Frequent In Children with Seat Belt Injuries
Ill-fitting seatbelts raise the risk of serious injury to children involved in car accidents. And seat belt injuries should alert physicians to look for signs of more serious consequences, particularly spinal cord injury, which is not always immediately apparent.
"Unless physicians are diligent, spinal-cord injuries are hard to diagnose in children. In the event of a car accident, seat belt injuries such as bruising and tenderness should warrant a search for other injuries, including spinal-cord injury, vertebral fractures and intra-abdominal injuries. If spinal-cord injury is missed or not diagnosed early, the consequences can be devastating," said Harsh Grewal, M.D., in a report published in August issue of the Journal of Spinal Cord Medicine.
Grewal, a pediatric surgeon at Temple University School of Medicine and Hospital, and his colleagues reviewed 10 years' worth of medical literature on motor vehicle accidents and children. They found that children involved in car accidents who were inappropriately seatbelted were at higher risk for "seat-belt syndrome," a complex of injuries to the spine and abdomen. Consequently, when healthcare professionals see bruising or seat belt marks in pediatric car accident victims, they should have a high degree of suspicion about more serious injury.
Car accidents, the most common cause of injury and death in children, are also the most common cause of spinal cord injury in children and adolescents. Boys are more affected than girls, and the incidence increases with age. Children who are 4 to 8 years old are most likely to be using ill-fitting seatbelts or restraints.
Grewal recommends that an evaluation of a child or adolescent car-accident victim include a complete work-up for vertebral, spinal cord and intra-abdominal injuries. In addition to bruises or marks from the seat belt, clues of more serious injury include abdominal and/or spine tenderness, and neurological deficits. Ideal treatment of possible spinal-cord injury starts at the scene of the accident with proper stabilization and transportation of the victims. If a child with a spinal fracture has not been stabilized properly, movement can injure more tissue.
In general, seat belts and safety restraints should be adjusted according to age and weight.
For transportation safety information, visit the National Highway Traffic Safety Administration web site: nhtsa.dot/people/injury/childps/newtips/index.htm.
Source: Eryn Jelesiewicz
Temple University
"Unless physicians are diligent, spinal-cord injuries are hard to diagnose in children. In the event of a car accident, seat belt injuries such as bruising and tenderness should warrant a search for other injuries, including spinal-cord injury, vertebral fractures and intra-abdominal injuries. If spinal-cord injury is missed or not diagnosed early, the consequences can be devastating," said Harsh Grewal, M.D., in a report published in August issue of the Journal of Spinal Cord Medicine.
Grewal, a pediatric surgeon at Temple University School of Medicine and Hospital, and his colleagues reviewed 10 years' worth of medical literature on motor vehicle accidents and children. They found that children involved in car accidents who were inappropriately seatbelted were at higher risk for "seat-belt syndrome," a complex of injuries to the spine and abdomen. Consequently, when healthcare professionals see bruising or seat belt marks in pediatric car accident victims, they should have a high degree of suspicion about more serious injury.
Car accidents, the most common cause of injury and death in children, are also the most common cause of spinal cord injury in children and adolescents. Boys are more affected than girls, and the incidence increases with age. Children who are 4 to 8 years old are most likely to be using ill-fitting seatbelts or restraints.
Grewal recommends that an evaluation of a child or adolescent car-accident victim include a complete work-up for vertebral, spinal cord and intra-abdominal injuries. In addition to bruises or marks from the seat belt, clues of more serious injury include abdominal and/or spine tenderness, and neurological deficits. Ideal treatment of possible spinal-cord injury starts at the scene of the accident with proper stabilization and transportation of the victims. If a child with a spinal fracture has not been stabilized properly, movement can injure more tissue.
In general, seat belts and safety restraints should be adjusted according to age and weight.
For transportation safety information, visit the National Highway Traffic Safety Administration web site: nhtsa.dot/people/injury/childps/newtips/index.htm.
Source: Eryn Jelesiewicz
Temple University
Football Helmet Shields Can Protect Against A Kick In The Face
Researchers have determined that the two most popular brands of football helmet faceshields can withstand a hit equivalent to a kick in the face and provide that protection without disrupting players' vision.
The eye specialists at Ohio State University used an air cannon to hurl baseballs at the plastic faceshields. The impact was designed to mimic the force of a kick to the face, considered the riskiest way to sustain an eye injury in football.
The shields maintained their structural integrity after baseballs were propelled at the faceshields at velocities of up to 218 feet per second, or nearly 150 miles per hour. Measures of optical quality also showed that the curved, plastic shields do not add any corrections or distortions to players' vision.
The faceshields' protective potential bolsters an argument favoring mandatory use of the shields for college-age football players and younger, said Gregory Good, professor of clinical optometry at Ohio State and a coauthor of the study. Collegiate programs currently do not mandate their use.
"I think this would be a good idea not only from a collegiate standpoint, but all the way down to peewee football, especially for players with good vision in only one eye," Good said. "Players in the pros can make their own decisions, but it would be helpful to have coaches and managers on board to convince kids in high school and younger kids especially to wear faceshields. At that age, kids typically don't have enough experience to make a decision about safety on their own."
The research is published in a recent issue of the journal Optometry.
The study tested the two most popular collegiate and professional football helmet faceshields by manufacturers Oakley, based in Foothills Ranch, Calif., and Nike, based in Beaverton, Oregon. The companies donated faceshields for use in the study. The average cost is $45 to $50 per shield.
The researchers conducted the air cannon work at ICS Laboratories in Brunswick, Ohio. Good completed the study with Kathryn Baker, Deborah Grzybowski, William McLaughlin and Steven Katz of Ohio State's Department of Ophthalmology; Aaron Zimmerman of Ohio State's College of Optometry; and Dale Pfriem of ICS Laboratories.
Because no current performance standard exists for football helmet faceshields, the researchers used the air cannon testing method that is already approved to assess face protectors for baseball and lacrosse. The American Society for Testing and Materials sets the requirements for face and eye protection used in numerous sports.
In the study, 10 football visors from each company were struck once at numerous velocities. Two visors from each company were hit three times to evaluate the effects of repeated blows. Other faceshields were struck once in sub-freezing temperatures. None of the faceshields broke under any of the impact conditions.
The highest velocity equated to an impact force of about 2,500 Newtons, or 562 pounds of force. Previous research has reported a maximum kicking motion impact of 2,439 Newtons, or 548 pounds of force, in soccer.
The researchers determined that new football faceshields hold up solidly to high-velocity impact, but whether that strength is maintained over the duration of one or more football seasons is open to debate and is part of continuing research.
The researchers also analyzed various qualities of the curved plastic that might affect vision - such as light distribution, hazing or a prismatic effect that changes the direction of light. The shields exceeded standards related to these measures.
"Both brands are of high optical quality, and both hold up to high-velocity impact," Good said.
Though serious eye injuries in football are relatively rare, the researchers mentioned the case of Orlando Brown of the Cleveland Browns, whose eye was inadvertently hit by a referee's thrown penalty flag during a game in 1999. He missed several seasons after the injury.
A summary of National Electronic Injury Surveillance System data shows that about one-third of football-related eye injuries documented between 2002 and 2006 were caused by the football itself and almost one-fifth were from finger pokes. The data do not specify whether these injuries occurred during organized games or "street" play. Other data also show in 2000, U.S. emergency rooms treated an estimated 40,000 sports-related eye injuries.
And more than 10 years ago, the sports safety committees of the American Academy of Pediatrics and the American Academy of Ophthalmology issued a report recommending that football helmets be equipped with a polycarbonate faceshield for face and eye protection. They were responding to a 1993 report by Prevent Blindness America indicating that football was the fifth-greatest contributor to sports-related eye injuries in patients younger than 25.
Good said that rather than trying to judge players' susceptibility to eye injuries, the researchers focused on outlining the potential benefits that faceshields would provide.
But they know there is more to the story. They are following up by surveying football and equipment managers at about 120 collegiate programs in the United States to gauge player use of and attitudes about helmet faceshields. The researchers also have exposed new faceshields to three hours of sunlight per day this autumn and will retest their impact resistance after a season's worth of exposure to see if the radiation affects the faceshields' durability.
"We noticed the older faceshields we used in a pilot study didn't hold up as well, and we believe it could be because of exposure to radiation, at least in part," Good said.
None of the researchers has any financial arrangement with the companies that donated study materials.
Ohio State University
The eye specialists at Ohio State University used an air cannon to hurl baseballs at the plastic faceshields. The impact was designed to mimic the force of a kick to the face, considered the riskiest way to sustain an eye injury in football.
The shields maintained their structural integrity after baseballs were propelled at the faceshields at velocities of up to 218 feet per second, or nearly 150 miles per hour. Measures of optical quality also showed that the curved, plastic shields do not add any corrections or distortions to players' vision.
The faceshields' protective potential bolsters an argument favoring mandatory use of the shields for college-age football players and younger, said Gregory Good, professor of clinical optometry at Ohio State and a coauthor of the study. Collegiate programs currently do not mandate their use.
"I think this would be a good idea not only from a collegiate standpoint, but all the way down to peewee football, especially for players with good vision in only one eye," Good said. "Players in the pros can make their own decisions, but it would be helpful to have coaches and managers on board to convince kids in high school and younger kids especially to wear faceshields. At that age, kids typically don't have enough experience to make a decision about safety on their own."
The research is published in a recent issue of the journal Optometry.
The study tested the two most popular collegiate and professional football helmet faceshields by manufacturers Oakley, based in Foothills Ranch, Calif., and Nike, based in Beaverton, Oregon. The companies donated faceshields for use in the study. The average cost is $45 to $50 per shield.
The researchers conducted the air cannon work at ICS Laboratories in Brunswick, Ohio. Good completed the study with Kathryn Baker, Deborah Grzybowski, William McLaughlin and Steven Katz of Ohio State's Department of Ophthalmology; Aaron Zimmerman of Ohio State's College of Optometry; and Dale Pfriem of ICS Laboratories.
Because no current performance standard exists for football helmet faceshields, the researchers used the air cannon testing method that is already approved to assess face protectors for baseball and lacrosse. The American Society for Testing and Materials sets the requirements for face and eye protection used in numerous sports.
In the study, 10 football visors from each company were struck once at numerous velocities. Two visors from each company were hit three times to evaluate the effects of repeated blows. Other faceshields were struck once in sub-freezing temperatures. None of the faceshields broke under any of the impact conditions.
The highest velocity equated to an impact force of about 2,500 Newtons, or 562 pounds of force. Previous research has reported a maximum kicking motion impact of 2,439 Newtons, or 548 pounds of force, in soccer.
The researchers determined that new football faceshields hold up solidly to high-velocity impact, but whether that strength is maintained over the duration of one or more football seasons is open to debate and is part of continuing research.
The researchers also analyzed various qualities of the curved plastic that might affect vision - such as light distribution, hazing or a prismatic effect that changes the direction of light. The shields exceeded standards related to these measures.
"Both brands are of high optical quality, and both hold up to high-velocity impact," Good said.
Though serious eye injuries in football are relatively rare, the researchers mentioned the case of Orlando Brown of the Cleveland Browns, whose eye was inadvertently hit by a referee's thrown penalty flag during a game in 1999. He missed several seasons after the injury.
A summary of National Electronic Injury Surveillance System data shows that about one-third of football-related eye injuries documented between 2002 and 2006 were caused by the football itself and almost one-fifth were from finger pokes. The data do not specify whether these injuries occurred during organized games or "street" play. Other data also show in 2000, U.S. emergency rooms treated an estimated 40,000 sports-related eye injuries.
And more than 10 years ago, the sports safety committees of the American Academy of Pediatrics and the American Academy of Ophthalmology issued a report recommending that football helmets be equipped with a polycarbonate faceshield for face and eye protection. They were responding to a 1993 report by Prevent Blindness America indicating that football was the fifth-greatest contributor to sports-related eye injuries in patients younger than 25.
Good said that rather than trying to judge players' susceptibility to eye injuries, the researchers focused on outlining the potential benefits that faceshields would provide.
But they know there is more to the story. They are following up by surveying football and equipment managers at about 120 collegiate programs in the United States to gauge player use of and attitudes about helmet faceshields. The researchers also have exposed new faceshields to three hours of sunlight per day this autumn and will retest their impact resistance after a season's worth of exposure to see if the radiation affects the faceshields' durability.
"We noticed the older faceshields we used in a pilot study didn't hold up as well, and we believe it could be because of exposure to radiation, at least in part," Good said.
None of the researchers has any financial arrangement with the companies that donated study materials.
Ohio State University
Zimmer Introduces A Move Forward In Mobile Bearing Knee Design
Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH), a global leader in musculoskeletal care, launched the Zimmer NexGen LPS-Flex Mobile Bearing Knee with Prolong Highly Crosslinked Polyethylene (XLPE) in the United States. The LPS-Flex Mobile Bearing knee provides a revolutionary anteriorly-positioned pivot near the entry point of the anterior cruciate ligament (ACL), replicating the anatomic center of knee rotation.
The LPS-Flex Mobile system is backed by more than ten years of successful clinical history in Europe and Japan. Since the system's launch, more than 130,000 LPS-Flex Mobile knees have been implanted worldwide.
"Our Prolong Highly Crosslinked Polyethylene provides a number of clinical advantages, including reduced wear and delamination resistance," said Jeff McCaulley, Zimmer President, Reconstructive. "Applying this exciting material to our already successful NexGen LPS-Flex Mobile Bearing Knee System represents a major step forward in mobile bearing design."
During in vitro wear simulator testing, the LPS-Flex Mobile with Prolong Polyethylene system demonstrated an 83 percent wear reduction compared to conventional polyethylene.
Zimmer was the first company to launch XLPE over nine years ago for the NexGen Fixed Bearing system. Since its launch, the blend specifically formulated for the knee has been utilized in more than 450,000 implantations worldwide and has demonstrated an 81% (CR) and 78% (PS) wear reduction compared to conventional poly during in vitro wear simulator testing.
Source: Zimmer Holdings, Inc
The LPS-Flex Mobile system is backed by more than ten years of successful clinical history in Europe and Japan. Since the system's launch, more than 130,000 LPS-Flex Mobile knees have been implanted worldwide.
"Our Prolong Highly Crosslinked Polyethylene provides a number of clinical advantages, including reduced wear and delamination resistance," said Jeff McCaulley, Zimmer President, Reconstructive. "Applying this exciting material to our already successful NexGen LPS-Flex Mobile Bearing Knee System represents a major step forward in mobile bearing design."
During in vitro wear simulator testing, the LPS-Flex Mobile with Prolong Polyethylene system demonstrated an 83 percent wear reduction compared to conventional polyethylene.
Zimmer was the first company to launch XLPE over nine years ago for the NexGen Fixed Bearing system. Since its launch, the blend specifically formulated for the knee has been utilized in more than 450,000 implantations worldwide and has demonstrated an 81% (CR) and 78% (PS) wear reduction compared to conventional poly during in vitro wear simulator testing.
Source: Zimmer Holdings, Inc
New Technology Could Help Prevent Fractures In Humans And Horses
Researchers are developing a monitoring system similar to those used by earthquake seismologists to detect tiny cracks in bones, a technology that could help prevent fractures in humans and racehorses.The new monitoring system records "acoustic emission data," or sound waves created by the tiny bone fissures. The same sorts of acoustic emissions are used to monitor the integrity of bridges, other structures and mechanical parts like helicopter turbine blades, said Ozan Akkus, an associate professor in Purdue University's Weldon School of Biomedical Engineering.
"When a microcrack occurs in a bone it generates sound waves similar to those created by earthquakes," Akkus said. "The goal is to create a wearable device that would alert the person when a stress fracture was imminent so that they could stop rigorous physical activity long enough for the bone to heal."
Researchers at Purdue have designed wearable acoustic emission sensors, which could be used to monitor the formation of these "microcracks" in bones that can lead to hairline stress fractures unless detected in time. The technology might help prevent serious fractures in racehorses that could cause lameness and lead to more serious catastrophic bone failure.
Catastrophic injuries are rare in racehorses but still remain a major concern to horse owners and racing fans. This problem was highlighted by the recent tragedy involving this year's Kentucky Derby second-place finisher Eight Belles. The 3-year-old filly broke both ankles as she was slowing down at the end of the race and had to be euthanized. Big Brown won both the Kentucky Derby and Preakness Stakes and is favored to win the Belmont Stakes on Saturday (June 7).
"The need for new technologies to prevent stress fractures and the many other causes of catastrophic injury to racehorses is great," said Stephen Adams, a veterinarian and professor in the Purdue School of Veterinary Medicine.
"There is a huge investment in thoroughbred and standardbred horses, and a thoroughbred racehorse can cost between $4,000 to $10 million and cost thousands more each month for training. About 70 percent of young thoroughbreds develop microcracks in their cannon bones known as bucked shins. About 10 percent of horses with bucked shins will have radiographic evidence of stress fractures. One of our goals is to prevent stress fractures and curtail catastrophic fractures."
Estimated losses attributed to bone fractures in thoroughbred or standardbred horses used in the horse racing industry exceed $10 million annually.
"While it is still in the early stages, this technology holds great promise for horses," said Adams, who specializes in equine lameness and surgery and is collaborating with Akkus in testing the system on horses. "These horses are running 40 miles an hour, and if there is a microfracture in the animal there is danger it will become a catastrophic failure. Currently, microfractures are not visible on an X-ray, and we need a viable way to detect tiny fractures before they become stress fractures or catastrophic fractures."
Shane Fimbel, technology transfer manager for the Purdue Research Foundation's Office of Technology Commercialization, is working with Adams and Akkus to move the technology to the market.
"This technology is important in many ways, but in particular with horses and other animals because they cannot articulate why they are in pain," Fimbel said.
Such a technology also might protect soldiers, athletes and dancers. Akkus will be visiting West Point this summer to test the monitoring system on cadets going through basic training.
"Strenuous military exercises subject soldiers to prolonged physical activity in which relatively small forces are repeatedly exerted on bones," Akkus said. "The forces are not initially strong enough to break a bone, but it's the repetition that poses the most danger by causing microscopic cracks to accumulate over time and eventually result in stress fractures."
Depending on the service branch and type of training, 5 percent to 20 percent of U.S. basic training recruits experience stress fractures of the lower extremities, with the highest incidence in women recruits, Akkus said.
About 5 percent to 10 percent of athletes experience stress fractures.
A stress fracture occurs because cracks form when mineralized collagen fibers in bone fail, producing sound waves that cause a rippling motion on the skin's surface.
"This is the same thing that happens during an earthquake, but on a microscopic scale and at a higher frequency," Akkus said. "Instead of an earthquake-size opening, these cracks are about a tenth of a millimeter wide."
Accumulating cracks sometimes cause "spontaneous fractures" that occur without warning, afflicting the young and old alike, including athletes and elderly people suffering from osteoporosis.
A major factor in the crack formation is the dynamic process bones use to continually rebuild themselves. When bone is damaged, specialized cells bore tunnel-like holes to remove the damaged tissue and then fill in the resulting cavity with new bone.
Hard physical activity without rest increases the stress in these porous areas that are under repair.
One reason it's difficult to diagnose the hairline fractures is because they are caused by the gradual accumulation of microscopic cracks, which are not detectable with conventional imaging technologies.
"It's really hard to measure stresses in bone without cutting open the bone to study it," Akkus said. "And there is very little warning because you don't have horrible pain. You might have some discomfort, but you can keep exercising or whatever activity you are doing."
As hard as it is for humans to discern the pain due to developing stress fractures, it is relatively impossible for a horse to overtly display its discomfort, making this technology all the more valuable for equine applications.
"Ultimately, we would like to do real-time monitoring of damage activity and learn how to distinguish between a small crack and a more structurally threatening defect," Akkus said. "There are different types of cracks that occur, and it's important to be able to distinguish among them so that we can determine how serious the damage is."
To differentiate the various types of cracks, researchers are integrating "pattern recognition" software and earthquake models, working with Robert Nowak, a Purdue professor of earth and atmospheric sciences. The multidisciplinary research involves biomedical and electrical engineering, veterinary medicine, and earth and atmospheric sciences.
Bones most affected in horses are the cannon bones of the front limb, which are the equivalent of human finger bones. The most commonly affected bones in humans are those in the feet, legs and hips, particularly the ball-and-socket joints that connect the legs to the pelvis.
Researchers at Purdue and the University of Toledo have jointly filed patents on the discovery through the Purdue Research Foundation Office of Technology Commercialization.
The Purdue Research Park is part of the Purdue Research Foundation, a private, nonprofit foundation created to assist Purdue University in the area of economic development. In addition to the Purdue Research Park in West Lafayette, the foundation has established or is currently constructing technology parks in other locations around Indiana including Merrillville, New Albany and Indianapolis.
Writers: Cynthia Sequin and Emil Venere
purdue
"When a microcrack occurs in a bone it generates sound waves similar to those created by earthquakes," Akkus said. "The goal is to create a wearable device that would alert the person when a stress fracture was imminent so that they could stop rigorous physical activity long enough for the bone to heal."
Researchers at Purdue have designed wearable acoustic emission sensors, which could be used to monitor the formation of these "microcracks" in bones that can lead to hairline stress fractures unless detected in time. The technology might help prevent serious fractures in racehorses that could cause lameness and lead to more serious catastrophic bone failure.
Catastrophic injuries are rare in racehorses but still remain a major concern to horse owners and racing fans. This problem was highlighted by the recent tragedy involving this year's Kentucky Derby second-place finisher Eight Belles. The 3-year-old filly broke both ankles as she was slowing down at the end of the race and had to be euthanized. Big Brown won both the Kentucky Derby and Preakness Stakes and is favored to win the Belmont Stakes on Saturday (June 7).
"The need for new technologies to prevent stress fractures and the many other causes of catastrophic injury to racehorses is great," said Stephen Adams, a veterinarian and professor in the Purdue School of Veterinary Medicine.
"There is a huge investment in thoroughbred and standardbred horses, and a thoroughbred racehorse can cost between $4,000 to $10 million and cost thousands more each month for training. About 70 percent of young thoroughbreds develop microcracks in their cannon bones known as bucked shins. About 10 percent of horses with bucked shins will have radiographic evidence of stress fractures. One of our goals is to prevent stress fractures and curtail catastrophic fractures."
Estimated losses attributed to bone fractures in thoroughbred or standardbred horses used in the horse racing industry exceed $10 million annually.
"While it is still in the early stages, this technology holds great promise for horses," said Adams, who specializes in equine lameness and surgery and is collaborating with Akkus in testing the system on horses. "These horses are running 40 miles an hour, and if there is a microfracture in the animal there is danger it will become a catastrophic failure. Currently, microfractures are not visible on an X-ray, and we need a viable way to detect tiny fractures before they become stress fractures or catastrophic fractures."
Shane Fimbel, technology transfer manager for the Purdue Research Foundation's Office of Technology Commercialization, is working with Adams and Akkus to move the technology to the market.
"This technology is important in many ways, but in particular with horses and other animals because they cannot articulate why they are in pain," Fimbel said.
Such a technology also might protect soldiers, athletes and dancers. Akkus will be visiting West Point this summer to test the monitoring system on cadets going through basic training.
"Strenuous military exercises subject soldiers to prolonged physical activity in which relatively small forces are repeatedly exerted on bones," Akkus said. "The forces are not initially strong enough to break a bone, but it's the repetition that poses the most danger by causing microscopic cracks to accumulate over time and eventually result in stress fractures."
Depending on the service branch and type of training, 5 percent to 20 percent of U.S. basic training recruits experience stress fractures of the lower extremities, with the highest incidence in women recruits, Akkus said.
About 5 percent to 10 percent of athletes experience stress fractures.
A stress fracture occurs because cracks form when mineralized collagen fibers in bone fail, producing sound waves that cause a rippling motion on the skin's surface.
"This is the same thing that happens during an earthquake, but on a microscopic scale and at a higher frequency," Akkus said. "Instead of an earthquake-size opening, these cracks are about a tenth of a millimeter wide."
Accumulating cracks sometimes cause "spontaneous fractures" that occur without warning, afflicting the young and old alike, including athletes and elderly people suffering from osteoporosis.
A major factor in the crack formation is the dynamic process bones use to continually rebuild themselves. When bone is damaged, specialized cells bore tunnel-like holes to remove the damaged tissue and then fill in the resulting cavity with new bone.
Hard physical activity without rest increases the stress in these porous areas that are under repair.
One reason it's difficult to diagnose the hairline fractures is because they are caused by the gradual accumulation of microscopic cracks, which are not detectable with conventional imaging technologies.
"It's really hard to measure stresses in bone without cutting open the bone to study it," Akkus said. "And there is very little warning because you don't have horrible pain. You might have some discomfort, but you can keep exercising or whatever activity you are doing."
As hard as it is for humans to discern the pain due to developing stress fractures, it is relatively impossible for a horse to overtly display its discomfort, making this technology all the more valuable for equine applications.
"Ultimately, we would like to do real-time monitoring of damage activity and learn how to distinguish between a small crack and a more structurally threatening defect," Akkus said. "There are different types of cracks that occur, and it's important to be able to distinguish among them so that we can determine how serious the damage is."
To differentiate the various types of cracks, researchers are integrating "pattern recognition" software and earthquake models, working with Robert Nowak, a Purdue professor of earth and atmospheric sciences. The multidisciplinary research involves biomedical and electrical engineering, veterinary medicine, and earth and atmospheric sciences.
Bones most affected in horses are the cannon bones of the front limb, which are the equivalent of human finger bones. The most commonly affected bones in humans are those in the feet, legs and hips, particularly the ball-and-socket joints that connect the legs to the pelvis.
Researchers at Purdue and the University of Toledo have jointly filed patents on the discovery through the Purdue Research Foundation Office of Technology Commercialization.
The Purdue Research Park is part of the Purdue Research Foundation, a private, nonprofit foundation created to assist Purdue University in the area of economic development. In addition to the Purdue Research Park in West Lafayette, the foundation has established or is currently constructing technology parks in other locations around Indiana including Merrillville, New Albany and Indianapolis.
Writers: Cynthia Sequin and Emil Venere
purdue
Elsevier Expands Procedures Consult With Emergency Medicine, Orthopedics And Anesthesia Procedures
Elsevier, the leading publisher of scientific, technical and medical information products and services, has announced hat it has added three new modules to Procedures Consult™ in orthopedics, anesthesia and emergency medicine. Procedures Consult (proceduresconsult/), which Elsevier launched in July 2007 with 40 procedures in internal medicine, is an online multimedia resource that helps physicians, medical residents and students learn, perform and test their knowledge of the most frequent medical procedures. The site currently contains 140 separate procedures including actual procedure videos, text and animation.
Other unique features include highlighted patient safety guidelines consistent with standards established by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Occupational Safety and Health Administration (OSHA).
"Medical procedures are potentially high-risk situations, particularly when physicians are learning the procedure for the first or second time, or if they have not performed the procedure recently," said Jonathan Teich, MD, PhD, and Elsevier's Chief Medical Informatics Officer. "By providing immediate online access to detailed step-by-step multimedia information on procedure execution, along with indications and other considerations, Procedures Consult reduces the potential for medical errors and complications. Its ability to document procedures for residency requirements and competency tracking adds additional value for education and quality improvement."
In addition to medical students and residents, other potential users of Procedures Consult include practicing physicians, physician assistants, certified registered nurse anesthetists, operating room nurses, advanced practice nurses and respiratory therapists.
Healthcare organizations, including hospitals, medical groups and medical schools, can customize Procedures Consult to fit their needs. They can add procedure-specific alerts and links to organizational resources, such as informed consent forms, hospital standard procedures or patient education materials, while also monitoring physician test completion for credentialing compliance.
New Content
Specific content delivered in the new modules includes:
Orthopedics
39 new procedures representing over 78 surgical techniques
Provides expert video content developed in conjunction with Campbell Clinic
Text and illustration content adapted from Campbell's Operative Orthopaedics, 11th edition
Anesthesia
34 procedures, including coverage of both general and regional anesthesia
Provides content developed in conjunction with the University of Pennsylvania, Department of Anesthesia (Lee A. Fleisher, M.D., Chair)
Emergency Medicine
50 procedures covering key procedures in both emergency and internal medicine
Expert video content developed in conjunction with Gary S. Setnik, M.D., Chair, Dept. of Emergency Medicine and Todd W. Thomsen, M.D. at Mt. Auburn Hospital, an affiliate of Harvard Medical School
Text and illustration content adapted from Roberts & Hedges, Clinical Procedures in Emergency Medicine, 5th ed. (2009 publication)
An Open House event, where users can view the entire site for free, is available from April 15 - May 15, 2008. More information is available at proceduresconsult/.
About Elsevier
Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health
communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of
innovative electronic products, such as ScienceDirect (sciencedirect/), MD Consult
(mdconsult/), Scopus (info.scopus/), bibliographic databases, and online reference works.
Elsevier (elsevier/) is a global business headquartered in Amsterdam, The Netherlands
and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (reedelsevier/), a world-leading publisher and information provider. Operating in the science and medical, legal, education and
business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of
delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
Source: Tom Reller
Elsevier
Other unique features include highlighted patient safety guidelines consistent with standards established by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Occupational Safety and Health Administration (OSHA).
"Medical procedures are potentially high-risk situations, particularly when physicians are learning the procedure for the first or second time, or if they have not performed the procedure recently," said Jonathan Teich, MD, PhD, and Elsevier's Chief Medical Informatics Officer. "By providing immediate online access to detailed step-by-step multimedia information on procedure execution, along with indications and other considerations, Procedures Consult reduces the potential for medical errors and complications. Its ability to document procedures for residency requirements and competency tracking adds additional value for education and quality improvement."
In addition to medical students and residents, other potential users of Procedures Consult include practicing physicians, physician assistants, certified registered nurse anesthetists, operating room nurses, advanced practice nurses and respiratory therapists.
Healthcare organizations, including hospitals, medical groups and medical schools, can customize Procedures Consult to fit their needs. They can add procedure-specific alerts and links to organizational resources, such as informed consent forms, hospital standard procedures or patient education materials, while also monitoring physician test completion for credentialing compliance.
New Content
Specific content delivered in the new modules includes:
Orthopedics
39 new procedures representing over 78 surgical techniques
Provides expert video content developed in conjunction with Campbell Clinic
Text and illustration content adapted from Campbell's Operative Orthopaedics, 11th edition
Anesthesia
34 procedures, including coverage of both general and regional anesthesia
Provides content developed in conjunction with the University of Pennsylvania, Department of Anesthesia (Lee A. Fleisher, M.D., Chair)
Emergency Medicine
50 procedures covering key procedures in both emergency and internal medicine
Expert video content developed in conjunction with Gary S. Setnik, M.D., Chair, Dept. of Emergency Medicine and Todd W. Thomsen, M.D. at Mt. Auburn Hospital, an affiliate of Harvard Medical School
Text and illustration content adapted from Roberts & Hedges, Clinical Procedures in Emergency Medicine, 5th ed. (2009 publication)
An Open House event, where users can view the entire site for free, is available from April 15 - May 15, 2008. More information is available at proceduresconsult/.
About Elsevier
Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health
communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of
innovative electronic products, such as ScienceDirect (sciencedirect/), MD Consult
(mdconsult/), Scopus (info.scopus/), bibliographic databases, and online reference works.
Elsevier (elsevier/) is a global business headquartered in Amsterdam, The Netherlands
and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (reedelsevier/), a world-leading publisher and information provider. Operating in the science and medical, legal, education and
business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of
delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
Source: Tom Reller
Elsevier
Bone Implant Offers Hope For Skull Deformities
A synthetic bone matrix offers hope for babies born with craniosynostosis, a condition that causes the plates in the skull to fuse too soon. Implants replacing some of the infant's bone with the biodegradable matrix could eliminate some of the operations currently used to treat the condition.
"The remarkable thing about this is the finding that the composition of the matrix changes what the cells around it do. Cells begin producing natural drugs to drive bone healing in direct response to the composition of the bone matrix," said Kent Leach, professor of biomedical engineering at UC Davis.
The material is currently being tested in experiments with rats. Human trials will depend upon the success of tests in animals.
The human skull is not a smooth dome, but a patchwork of fused bones that resembles a soccer ball rather than an egg. At birth, the skull contains 45 separate pieces, joined by connective tissue, that slowly fuse together into solid bone. In most babies, this process keeps pace with brain growth, resulting in a normally shaped head.
However, one in every 2,000 babies is born with craniosynostosis, where the plates fuse and the skull becomes rigid. This leaves less room for the brain to grow, leading to developmental disabilities, and cranial and facial deformities.
In the standard surgery, surgeons remove fused bones, break them up and reposition some of the pieces along the edges to protect the brain. This usually slows the bone growth and allows the brain to grow. Nevertheless, 6 to 8 percent of babies will need a second operation and 25 percent of those will need yet a third operation.
Leach believes that the environment surrounding the cells might be sending the wrong instructions, causing cells to grow wrong. Leach's biodegradable implant is impregnated with stem cells from bone marrow and a synthetic version of hydroxyapatite, a chemical produced naturally in the body to stimulate bone growth. Once implanted, bone-forming cells enter the matrix. Leach's research with rats shows dense connective tissue, suggestive of bone formation, only eight weeks after implantation.
Leach hopes that his new matrix will encourage the growth of healthy tissue and eliminate the need for second and third surgeries. "The matrix will resorb over time, leaving only the child's own bone," he said.
Leach's work is funded by a grant from The Hartwell Foundation.
Source: Andy Fell
University of California - Davis
"The remarkable thing about this is the finding that the composition of the matrix changes what the cells around it do. Cells begin producing natural drugs to drive bone healing in direct response to the composition of the bone matrix," said Kent Leach, professor of biomedical engineering at UC Davis.
The material is currently being tested in experiments with rats. Human trials will depend upon the success of tests in animals.
The human skull is not a smooth dome, but a patchwork of fused bones that resembles a soccer ball rather than an egg. At birth, the skull contains 45 separate pieces, joined by connective tissue, that slowly fuse together into solid bone. In most babies, this process keeps pace with brain growth, resulting in a normally shaped head.
However, one in every 2,000 babies is born with craniosynostosis, where the plates fuse and the skull becomes rigid. This leaves less room for the brain to grow, leading to developmental disabilities, and cranial and facial deformities.
In the standard surgery, surgeons remove fused bones, break them up and reposition some of the pieces along the edges to protect the brain. This usually slows the bone growth and allows the brain to grow. Nevertheless, 6 to 8 percent of babies will need a second operation and 25 percent of those will need yet a third operation.
Leach believes that the environment surrounding the cells might be sending the wrong instructions, causing cells to grow wrong. Leach's biodegradable implant is impregnated with stem cells from bone marrow and a synthetic version of hydroxyapatite, a chemical produced naturally in the body to stimulate bone growth. Once implanted, bone-forming cells enter the matrix. Leach's research with rats shows dense connective tissue, suggestive of bone formation, only eight weeks after implantation.
Leach hopes that his new matrix will encourage the growth of healthy tissue and eliminate the need for second and third surgeries. "The matrix will resorb over time, leaving only the child's own bone," he said.
Leach's work is funded by a grant from The Hartwell Foundation.
Source: Andy Fell
University of California - Davis
Accurate Prediction Of Fracture Risk In Osteoporotic Women
Researchers have developed a mathematic formula to predict a woman's risk of osteoporotic fracture. The equation has proved 75 percent accurate and will allow physicians to tailor their treatment strategies to help women prevent fractures of fragile bones. The study appears in the October issue of Radiology.
"Approximately 45 percent of women have different levels of bone mineral density between their hip and their spine, leading to uncertainty as to how physicians should assess their future fracture risk," said the study's lead author, Margaret Joy Henry, B.Sc(Hons)., Ph.D., statistician in the Department of Clinical and Biomedical Sciences at The University of Melbourne, Australia. "We have derived an equation that successfully predicted 75 percent of fractures in women, two years after their initial measurements were taken."
Women with osteoporosis have brittle bones that are more likely to break as a result of a minor bump or fall. Bones affected by osteoporosis are less dense than normal bones, due to larger pores in the bone, reduced calcium levels and fewer blood vessels.
The equation developed by Dr. Henry and colleagues takes into account a variety of risk factors, not just bone mineral density. A patient's likelihood of falling, low bone mass, excess or low body weight and additional factors are combined into a single formula that can indicate to a physician how serious a woman's fracture risk may be. Treatment strategies may then be targeted on the basis of a woman's predicted outcome.
A total of 231 elderly women who had sustained a low-trauma fracture of the hip, spine, humerus or forearm during a two-year period were recruited, as well as 448 elderly women who were selected randomly and had not sustained a fracture during the same two-year period.
The equation was developed based on measurements obtained in this study population. It was then tested in a third group of women from the community, who were randomly selected to be followed for a six-year period to determine the success of the formula for predicting fractures.
By using the formula, 75 percent of fractures were successfully predicted two years after the baseline measurements were obtained. The authors also discovered that heavier body weight seemed to increase the force applied to the skeleton during a fall. Findings of most previous studies indicated that lighter body weight led to increased risk of fracture, due to lower bone mass.
Development of this formula to predict future fracture risk is important because it will allow physicians to better adapt treatment strategies for women with osteoporosis, especially by taking into consideration different bone density measurements throughout the body. A variety of treatment regimens can be used, including hormone replacement therapy, non-hormonal medicines, vitamin D and calcium supplements, and additional therapies such as calcitriol--an active form of vitamin D that improves the absorption of calcium from the digestive process.
"As the average age of the population increases, the number of fractures attributable to osteoporosis is set to increase dramatically," said Dr. Henry. "The ability to predict fracture risk, based on simple clinical measurements, will assist in targeting treatment for people at highest risk, thus helping reduce the burden of this disease."
Dr. Henry and colleagues are currently assessing risk factors in a large cohort of men to develop a similar formula for use in the male population.
Journal attribution required.
Radiology is a monthly scientific journal devoted to clinical radiology and allied sciences. The journal is edited by Anthony V. Proto, M.D., School of Medicine, Virginia Commonwealth University, Richmond, Va. Radiology is owned and published by the Radiological Society of North America, Inc. (RSNA/radiologyjnl)
The Radiological Society of North America (RSNA) is an association of more than 38,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill. (RSNA)
"Fracture Risk (FRISK) Score: Geelong Osteoporosis Study." Collaborating with Dr. Henry on this paper were Julie Anne Pasco, B.Sc(Hons)., Ph.D., Kerrie Margaret Sanders, M.Nutr., Ph.D., Geoffrey Charles Nicholson, M.B.B.S., Ph.D., F.R.A.C.P., F.R.C.P., and Mark Anthony Kotowicz, M.B.B.S., F.R.A.C.P.
Contact: Heather Babiar
Radiological Society of North America
"Approximately 45 percent of women have different levels of bone mineral density between their hip and their spine, leading to uncertainty as to how physicians should assess their future fracture risk," said the study's lead author, Margaret Joy Henry, B.Sc(Hons)., Ph.D., statistician in the Department of Clinical and Biomedical Sciences at The University of Melbourne, Australia. "We have derived an equation that successfully predicted 75 percent of fractures in women, two years after their initial measurements were taken."
Women with osteoporosis have brittle bones that are more likely to break as a result of a minor bump or fall. Bones affected by osteoporosis are less dense than normal bones, due to larger pores in the bone, reduced calcium levels and fewer blood vessels.
The equation developed by Dr. Henry and colleagues takes into account a variety of risk factors, not just bone mineral density. A patient's likelihood of falling, low bone mass, excess or low body weight and additional factors are combined into a single formula that can indicate to a physician how serious a woman's fracture risk may be. Treatment strategies may then be targeted on the basis of a woman's predicted outcome.
A total of 231 elderly women who had sustained a low-trauma fracture of the hip, spine, humerus or forearm during a two-year period were recruited, as well as 448 elderly women who were selected randomly and had not sustained a fracture during the same two-year period.
The equation was developed based on measurements obtained in this study population. It was then tested in a third group of women from the community, who were randomly selected to be followed for a six-year period to determine the success of the formula for predicting fractures.
By using the formula, 75 percent of fractures were successfully predicted two years after the baseline measurements were obtained. The authors also discovered that heavier body weight seemed to increase the force applied to the skeleton during a fall. Findings of most previous studies indicated that lighter body weight led to increased risk of fracture, due to lower bone mass.
Development of this formula to predict future fracture risk is important because it will allow physicians to better adapt treatment strategies for women with osteoporosis, especially by taking into consideration different bone density measurements throughout the body. A variety of treatment regimens can be used, including hormone replacement therapy, non-hormonal medicines, vitamin D and calcium supplements, and additional therapies such as calcitriol--an active form of vitamin D that improves the absorption of calcium from the digestive process.
"As the average age of the population increases, the number of fractures attributable to osteoporosis is set to increase dramatically," said Dr. Henry. "The ability to predict fracture risk, based on simple clinical measurements, will assist in targeting treatment for people at highest risk, thus helping reduce the burden of this disease."
Dr. Henry and colleagues are currently assessing risk factors in a large cohort of men to develop a similar formula for use in the male population.
Journal attribution required.
Radiology is a monthly scientific journal devoted to clinical radiology and allied sciences. The journal is edited by Anthony V. Proto, M.D., School of Medicine, Virginia Commonwealth University, Richmond, Va. Radiology is owned and published by the Radiological Society of North America, Inc. (RSNA/radiologyjnl)
The Radiological Society of North America (RSNA) is an association of more than 38,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill. (RSNA)
"Fracture Risk (FRISK) Score: Geelong Osteoporosis Study." Collaborating with Dr. Henry on this paper were Julie Anne Pasco, B.Sc(Hons)., Ph.D., Kerrie Margaret Sanders, M.Nutr., Ph.D., Geoffrey Charles Nicholson, M.B.B.S., Ph.D., F.R.A.C.P., F.R.C.P., and Mark Anthony Kotowicz, M.B.B.S., F.R.A.C.P.
Contact: Heather Babiar
Radiological Society of North America
Подписаться на:
Сообщения (Atom)