Once-Monthly Bonviva(R), An Important Advance In The Treatment Of Postmenopausal Osteoporosis

Data presented this week at the 33rd European Symposium on Calcified Tissues (ECTS) adds to the growing body of evidence that the only once-monthly bisphosphonate, Bonviva(R) (ibandronic acid), is proving to be an important step forwards in the treatment of osteoporosis. The data being presented at the ECTS meeting supports existing evidence in showing that Bonviva:


-- is highly effective1

-- is well-tolerated2

-- has a convenient once monthly dosing schedule that is preferred by women, which may therefore help them to stay on therapy3



Bonviva's benefit of less frequent dosing (compared to weekly bisphosphonates) has the potential to play a significant role to play in helping women with postmenopausal osteoporosis stay on their treatment. This is of particular importance as adherence to treatment is a major problem in the management of osteoporosis, with more than 50% of patients on a once-weekly bisphosphonate stopping treatment within a year.4,5 'Real life' efficacy can only be truly achieved if postmenopausal patients continue to take an effective treatment for a long period of time.



The Growing Body of Evidence



Bonviva, efficacy in osteoporosis with only one tablet once a month


Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62% in patients with postmenopausal osteoporosis.6 New analyses from the MOBILE 2-year (Monthly Oral iBandronate In LadiEs) study, presented at the 33rd European Symposium on Calcified Tissues (ECTS), confirm once-monthly Bonviva is highly effective at increasing lumbar spine and hip bone mineral density (BMD), an accepted surrogate for fracture risk reduction.1




Bonviva - a well-tolerated treatment option


Associated side effects are one of the main reasons patients stop taking their osteoporosis treatment.7 MOBILE showed that two years treatment with Bonviva once monthly was not associated with an increased incidence of upper gastrointestinal (GI) adverse events versus the daily dose. In addition, data showed there was no evidence that treatment led to an increased withdrawal due to upper GI adverse events compared to the 2.5mg daily regimen over two-years.2



Patient preference for once monthly dosing


Patient preference is becoming increasingly recognised as an important factor in ensuring treatment is taken for the long term as prescribed. Also presented at ECTS, the results of the BALTO II (Bonviva ALendronate Trial in Osteoporosis) multi-centre clinical study suggest that once-monthly bisphosphonate dosing has the potential to improve adherence, with over 70% of postmenopausal women with osteoporosis* preferring a once-monthly bisphosphonate, finding it more convenient than a once-weekly option.3
















BALTO II examined the treatment preferences of 321 women with postmenopausal osteoporosis in centres across the US and Europe and of the 93% who expressed a preference, * 70.6% preferred treatment with Bonviva taken once a month and 76.6% found it more convenient than weekly alendronate. 3 In the study, the most common reason women gave for their preference was that one tablet a month is easier to follow for a long time.3



Helping women to stay on therapy


Also at ECTS, the study design for PERSIST (PERsistence Study of Ibandronate verSus alendronaTe) was presented for the first time. This is a six-month prospective, randomised, open label, multicentre study of over 1,000 women with postmenopausal osteoporosis.8 PERSIST uses a study design that is as close to 'real life' as possible, with patients given prescriptions by their GP and required to visit the local pharmacist to receive the medication, as happens in normal practice.8 The results from the PERSIST trial will show whether patients on a monthly treatment programme stay on treatment longer than those taking a weekly option.



*who had tried both monthly and weekly treatments and who had expressed a preference




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.6


-- 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. Stone M, Henson J, Stakkesatd JA, Hughes C, Mairon N, et al. Once-monthly ibandronate dosing is more effective than daily dosing for improving bone mineral density: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.

2. Delmas PD, Stone M, Stakkestad JA, Leigh C, Hiltbrunner V et al. Upper gastrointestinal safety and tolerability profile of once-monthly oral ibandronate: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.

3. 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.

4. 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.

5. Cramer J, Amonkar MM, Hebborn A and Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? Journal Bone Mineral Research 2004; 19 Suppl 1: S448

6. 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.

7. IPSOS Health, European Survey of Physicians and women with osteoporosis, January-April 2005. Sponsored by Roche/GSK.

8. Cooper, A.L (on behalf of the PERSIST Study Investigators). Rationale and design of the PERSIST study (PERsistence Study of Ibandronate verSus alendronaTe). Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.


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