Women With Osteoporosis Prefer One Tablet Per Month, Study Shows

New US and European clinical data, presented for the first time at the Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), reveal more than 70% of postmenopausal women with osteoporosis* preferred a once-monthly bisphosphonate, finding it more convenient than a once-weekly option.(1)



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. (1) This finding is important as staying on treatment is a major issue in the management of osteoporosis - up to 60% of patients taking a once-weekly bisphosphonate stop treatment within a year, (2-5) so missing out on the bone building benefits these drugs can only provide over time. The authors conclude that a less frequent dosing regimen may help patients stay on their osteoporosis treatment for longer,(1) which ultimately should reduce the risk of fracture.(6) With the number of osteoporotic fractures in Europe estimated at 3.79 million,(7) improvements in the management of this disease are essential.



Commenting on the results, Dr Peyman Hadji, lead author and Head of the Department of Endocrinology, Osteoporosis and Reproductive Medicine at Philipps-University of Marburg, Germany said: "While we have a range of treatments shown to be effective in clinical studies, they only work if they are taken on a consistent and ongoing basis. From these data, it seems the majority of women with postmenopausal osteoporosis prefer to take just 12 tablets a year rather than 52. The main reason for their choice is that a monthly regimen is easier to follow for a long time. This study suggests that once-monthly dosing has the potential to enhance therapeutic adherence and improve overall treatment effectiveness in osteoporosis - welcome news for physicians."



Poor adherence has a negative effect on treatment outcomes. It leads to a significantly greater risk of fractures,(6,8) and smaller changes in both bone mineral density (BMD)(9,10) and the rate of bone turnover.(9)



Bonviva® has shown a reduction in the occurrence of new vertebral fractures of 62% over three years (11) and, as the first and only once monthly oral treatment for postmenopausal osteoporosis, 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) Vertebral fractures are the most frequently observed fractures in patients suffering from osteoporosis.



The BALTO (Bonviva ALendronate Trial in Osteoporosis) II study, presented at the Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Vienna, was conducted in centres across the US and Europe and examined the treatment preferences of 321 women with postmenopausal osteoporosis. 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 Fosamax® (alendronate sodium) taken weekly.(1)
















Elisabeth Steinm?ller, one of the women who took part in the study, said: "Many people don't appreciate how difficult it can be living with osteoporosis. I know it's important that I take my treatment but it can be hard. It's not as easy as just swallowing a tablet, because of the strict requirements that have to be followed, like staying upright and fasting. I preferred the once-monthly option as it was more convenient, and ultimately means I'm less likely to give up and stop altogether."



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



About BALTO II


BALTO II is a six-month, prospective, randomised, open-label crossover trial that included 321 women with postmenopausal osteoporosis who took both once-monthly oral Bonviva and once-weekly oral alendronate (70 mg) at separate times during the study. As is standard practice, the physicians involved in the study were aware of existing clinical data for both study medications and were therefore able to ensure all patients enrolled were suitable for either medicine. By the end of the trial, the majority of women reporting a preference (n = 299) chose the once monthly Bonviva regimen (70.6%). Of those reporting on convenience, 76.6% found the monthly Bonviva dose more convenient than weekly alendronate.



About Bonviva


-- Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 12,000 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.


-- Studies specifically designed to demonstrate reductions in non-vertebral or femoral neck fractures have not been conducted with Bonviva.


-- 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 Swissmedic approval in August 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. gsk




References

1. Hadji P, Benhamou C-L, Devas V, Masanauskaite D, Barrett-Connor E. Women With Postmenopausal Osteoporosis Prefer Once-Monthly Oral Ibandronate to Weekly Oral Alendronate: Results of BALTO II. Abstract presented at 6th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, Vienna, Austria 15-18 March 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. Fardellone P, Gaudin AF, Cotte FE, Lafuma A, Marchand C et al. Comparison of the persistence of daily and weekly bisphosphonates in French female patients treated for osteoporosis. Poster presented at presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA 23-27 September 2005.

4. Bartl R, Goette S, Hadji P, Hammerschmidt T. Persistence and compliance with daily and weekly-administered bisphosphonates for osteoporosis treatment in Germany. Poster presented at 5th European Congress on Clinical and Economic Aspects of Osteoporosis and Ostheoarthritis,16-19 March 2005, Rome, Italy.

5. 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.

6. 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)

7. Kanis JA and Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005; 16:229.

8. 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.

9. Eastell R, Garnero P, Vrijens B, van de Langedjc L, Pols, AP. et al. Influence of Patient Compliance with Risedronate Therapy on Bone Turnover Marker and Bone Mineral Density Response: The IMPACT Study. Calcif Tissue Int 2003;72:408.

10. Data on file, NDC Health Study. (Ref. 161-011), Hoffman-La Roche Inc, Nutley, NJ.

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.