More Osteoporosis Patients Stay On Treatment With Effective Once-Monthly Bonviva(R) Treatment Programme Versus Weekly Alendronate

New data from a 6 month clinical trial shows that women with postmenopausal osteoporosis have a 47% improvement in persistence with the once-monthly Bonviva treatment programme* compared with weekly alendronate.1



This finding is important as staying on treatment is a major issue in the management of osteoporosis - over half of patients taking a once-weekly bisphosphonate stop treatment within a year,2,3 missing out on the bone strengthening benefits these drugs can only provide over time. Patients who do not stay on treatment are more likely to break bones 4,5,6,7 which has a significant impact on their quality of life and can lead to increased hospitalisation rates and elevated costs for medical services.8



Bonviva is a potent and highly effective bisphosphonate that only has to be taken as one tablet, once a month. It is a major advance in the management of postmenopausal osteoporosis, as women gain all the bone strengthening benefits of bisphosphonates with a convenient once-a-month pill.9,10



Commenting on the results, PERSIST Lead Investigator Dr Alun Cooper said: "This novel clinical trial evaluates, for the first time, how the right treatment strategies can make it easier for women to stay on therapy. The results of this trial mark an important step forward in the treatment of osteoporosis - as we saw with the introduction of weekly treatments over daily, less frequent dosing is crucial in helping patients stay on therapy. The monthly regimen will help physicians to ensure their patients stay on therapy and get the bone strengthening benefits of their treatment."



PERSIST (PERsistence Study of Ibandronate verSus alendronaTe), presented at the International Osteoporosis Foundation World Congress on Osteoporosis (IOF WCO) in Toronto, Canada, was a large, randomised, multicentre study involving over 1,000 postmenopausal women in the United Kingdom.1 It was designed to investigate whether patients on the once monthly Bonviva programme stayed on treatment longer than those taking a weekly option.



Commenting on these latest results, Professor Dieter Felsenberg, a leading world authority on osteoporosis from the Center of Muscle and Bone Research at the Free University of Berlin, Germany said: "Osteoporosis is a disease which affects the whole skeleton. Bisphosphonates, the most widely prescribed treatment for this condition, are well known as a highly effective class of medicines because they strengthen bones, reducing the risk of fracture. However, they rely on patients taking them consistently and for the long term.



He continued: "The results of recent, robust studies show women with postmenopausal osteoporosis not only prefer an effective monthly option to a weekly one, but are also significantly more likely to stay on their treatment, and get the full fracture-preventing benefits of the class, if they are taking Bonviva."
















Previous robust clinical studies have shown more than 70% of women with postmenopausal osteoporosis preferred a once-monthly treatment regimen, finding it more convenient than a once-weekly option.9,10 These studies, combined with the results of PERSIST, show that women with postmenopausal osteoporosis prefer, and are more likely to stay on the once-monthly Bonviva programme.



Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62%.11 Bonviva also has proven superior efficacy in increasing spine and hip bone mineral density (a method used by physicians to assess osteoporosis and the accepted way to measure risk of fracture), compared with once-daily Bonviva.12



Bonviva is approved in over 60 countries around the world for the treatment of postmenopausal osteoporosis.



*The PERSIST (PERsistence Study of Ibandronate versus alendrontaTe) study was designed to replicate real life' as closely as possible. In the UK, patients prescribed Bonviva have access to a patient support programme (PSP), which is offered as part of the current prescribing practice. PSPs were therefore offered to patients participating in the PERSIST study.




About PERSIST


PERSIST was a six-month prospective, randomised, open label, multicentre study of 1,076 women with post-menopausal osteoporosis. The Bonviva once-monthly treatment programme comprises Bonviva 150mg and the option of a patient support programme (PSP). The patient support programme was comprised of a welcome pack, a once monthly call, and a quarterly newsletter.



Patients were randomly allocated to one of two treatment groups:


-- Group A: Once-monthly oral ibandronate (150mg) treatment programme (with a PSP offered to the patient)


-- Group B: Once-weekly oral alendronate (70mg)



PERSIST used a study design that is as close to 'real life' as possible. For example, patients were given prescriptions by their GP, and then visited the local pharmacist to receive the medication, as happens in normal practice. The participating healthcare professionals (GPs, nurses and pharmacists) were also instructed not to do anything extra or different to encourage patients to return for their repeat prescriptions.



About Bonviva


-- Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.


-- Once-monthly Bonviva is indicated for the treatment of osteoporosis in postmenopausal women. It works by reducing elevated bone turnover, increasing bone mineral density and reducing the incidence of vertebral fractures.


-- Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.11


-- Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.


-- Once-monthly oral Bonviva received European Union approval in September 2005 and Swiss medic approval in August 2005. Once monthly Boniva (the brand name in the US) received FDA approval in March 2005.



Roche/GSK Collaboration


In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.



About Roche


Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).



About GSK


GSK, one of the world's leading research-based pharmaceutical and healthcare
companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.



All trademarks used or mentioned in this release are legally protected.



Roche Healthkiosk, Osteoporosis:

health-kiosk.ch/start_osteo.htm

GSK website:

gsk



References



1. Cooper, A.L (on behalf of the PERSIST Study Investigators). Improved patient persistence on once-monthly dosing regime plus patient support compared with a weekly dosing regime. Abstract presented at the IOF World Congress on Osteoporosis, Canada 2-6 June 2006.



2. Cowell W, Fulford-Smith A, Poultney S. Adherence with bisphosphonate treatment for osteoporosis in UK patients. Poster presented the second joint meeting of the European Calcified Tissue Society and the International Bone Mineral Society, Geneva, 25-29 June 2005.



3. Cramer J, Amonkar M, Hebborn A, Altman R. Compliance and Persistence with Bisphosphonate Dosing Regimens Among Women with Postmenopausal Osteoporosis. Current Medical Research and Opinions 2005; 21(9): 1453-60.



4. Sebaldt R, Shane LG, Pham BZ, Cook RJ, Thabane L. et al. Impact of non-compliance and non-persistence with daily bisphosphonates on longer-term effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. J Bone Miner Res 2004;19 (Suppl. 1): (Abstract M423)



5. Siris E, Rosen CJ, Harris ST, Abbott TA, Barr CE, Silverman S. Adherence to bisphosphonate therapy: relationship to bone fractures at 24 months in women with postmenopausal osteoporosis. Abstract 397, oral and poster presentation at: Sixth International Symposium on Osteoporosis, National Osteoporosis Foundation, April 7, 2005, Washington, DC



6. Goettsch et al. Risk for osteoporotic fractures is reduced in persistent bisphosphonate users. J Bone Miner Res 2005;20(Suppl. 1):S278 (Abstract SU388)


7. Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 2004;15:1003-8.



8. Kanis JA, Delmas P, Burckhardt P, et al. (1997) Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int1997; 7:390.



9. Emkey R, Binkley N, Seidman L, et al. BALTO I: Women Treatment for Osteoporosis Rate Preference and Convenience for Once-Monthly Ibandronate versus Once-Weekly Alendronate. Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA 23-27 September 2005.



10. Benhamou C-L, Licata AA, Devas V, Masanauskaite D, Hadji P. Patient preference for once-monthly oral ibandronate and weekly oral alendronate in postmenopausal osteoporosis: the BALTO study. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.



11. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research 2004;19(8):1241-49.



12. McClung MR, Drezner MK, Reginster J-Y, Bolognese M, Hughes C et al. Once-Monthly Oral Ibandronate Is At Least As Effective As Daily Oral Ibandronate In Postmenopausal Osteoporosis: 2-Year Findings from MOBILE . Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA 23 - 27 September 2005.


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