Women with postmenopausal osteoporosis prefer new once monthly to weekly treatment, study

Main Category: Bones / Orthopaedics
Article Date: 02 Oct 2005 - 0:00 PST

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Over 70% of postmenopausal women with osteoporosis* who expressed a preference, preferred once-monthly Bonviva, finding it more convenient than a once-weekly treatment. This is according to new data presented at the 27th Annual Meeting of the American Society for Bone Mineral Research (ASBMR).1

Patient preference for once-monthly oral bisphosphonate Bonviva® 150mg (ibandronic acid) was clearly demonstrated in results from the BALTO study (Bonviva ALendronate Trial in Osteoporosis), The BALTO study is one of the few studies with a specific objective to compare patient preference for osteoporosis therapy within a clinical trial setting.1

BALTO examined the treatment preferences of 342 women and found that, of the 93% who expressed a preference, 71.4% preferred treatment with Bonviva taken once a month and 74.6% found it more convenient than Fosamax® (alendronate sodium) taken weekly. The study authors conclude that a less frequent dosing regimen may help patients stay on their osteoporosis treatment for longer.1

This is particularly important as many patients find osteoporosis therapy inconvenient, which may help to explain why up to two-thirds of patients stop taking their osteoporosis treatment within a year, 2 foregoing the bone building benefits these drugs can only provide over time.3

Poor adherence has a negative effect on treatment outcomes including lower gains in bone mineral density (BMD),4,5 smaller decreases in the rate of bone turnover4 and a significantly greater risk of fractures.6

Professor Jean-Yves Reginster, Professor of Epidemiology, Public Health & Health Economics, University of Liege, Belgiumcommented on the findings: "We know from previous studies that less frequent dosing regimens have a positive impact on patient adherence to bisphosphonate treatments. The BALTO study shows women actually prefer a once-monthly treatment to a weekly and find it more convenient."

*Who had tried both monthly and weekly treatments

Additional Study confirms longer term efficacy of once-monthly Bonviva

Also at ASBMR, 2-year data from MOBILE (Monthly Oral iBandronate In LadiEs) were presented for the first time in the US.7 Results confirmed that 150mg Bonviva, taken as one tablet per month, was proven statistically superior to once daily oral Bonviva in increasing spine and hip bone mineral density (a method used by physicians to assess the strength of the bones) over the two year period. 7 In an earlier study, the once daily dose was known to provide a reduction in the occurrence of new vertebral fractures (the most frequent observed fractures in patients suffering from osteoporosis) of 62% over three years.4 Vertebral fractures are the most frequently observed fractures in patients suffering from osteoporosis.

Professor Reginster added: "In addition, 2-year data from the MOBILEstudy mean doctors can be reassured the first once-monthly bisphosphonate, ibandronate, is at least as effective as the daily dose and is well-tolerated. These findings are exciting as we now have a new treatment regimen to offer patients, which may lead to improved adherence and therefore, better treatment outcomes."

Philip Sambrook, Professor of Rheumatology at Universityof Sydneyand RoyalNorthShoreHospital, Sydney, Australiasaid: "These new data confirm that ibandronate is an effective addition to the options available for the treatment of osteoporosis - a debilitating condition that affects 1 in 3 women over 50 worldwide. As physicians, we should remember that patient preference is an important factor in adherence to therapy and it should be considered when making prescribing decisions."

The once-monthly formulation was also found to be well tolerated, with very low withdrawals due to adverse events.8 No meaningful difference in the incidence of adverse events was found between once daily and once monthly Bonviva. 8

Major Head to Head Trial Announced

Also at ASBMR the study design for MOTION (Monthly Oral Therapy with Ibandronate for Osteoporosis iNtervention), was presented for the first time.9 This is an ongoing, large-scale clinical trial involving 1,900 patients that, for the first time, directly compares the relative efficacy and safety of Bonviva (ibandronate), the first once-monthly oral bisphosphonate against a weekly osteoporosis treatment alendronate.9 Head to head trials are conducted to compare the established efficacy of one treatment versus another. Physicians can compare treatments directly and evaluate whether a medicine is comparable or different based on the same criteria.

About BALTO

BALTO is a six-month, prospective, randomized, open-label 2 sequence, 2 period, crossover trial that included 342 women with postmenopausal osteoporosis who took once-monthly oral Bonviva and once-weekly oral alendronate (70 mg) at separate times of the study. By the end of the trial, the majority of women reporting a preference preferred the once-monthly Bonviva regimen (71.4 percent). Of those reporting on convenience, 74.6 percent found the monthly Bonviva dose more convenient than weekly alendronate.

About MOBILE

MOBILE (Monthly Oral iBandronate In LadiEs) is a two-year, randomized, double-blind trial comparing the efficacy and safety of monthly oral doses of ibandronate (100mg on a single day; 100mg as separate 50mg doses on two consecutive days; or 150mg on a single day) versus the oral daily regimen (2.5mg), approved by the FDA and European Commission, in 1,609 women with postmenopausal osteoporosis. The primary endpoint was analysed at 1 year.

About MOTION

The MOTION trial is designed to compare the efficacy of once-monthly oral ibandronate, a potent, bisphosphonate with proven antifracture efficacy when administered with extended dosing intervals, with weekly oral alendronate. In MOTION, a randomized, double-blind, double-dummy study, almost 1,900 women with postmenopausal osteoporosis will receive either 150 mg once-monthly oral ibandronate or 70 mg once-weekly oral alendronate for one year. To maintain blinding, participants will also receive once-monthly or weekly oral placebo, plus daily calcium (500-1500 mg) and vitamin D (400 IU). The co-primary study endpoints are percent change from baseline in lumbar spine and total hip bone mineral density (BMD) at one year. Secondary endpoints include percent change in hip trochanter BMD at one year and the biochemical marker of bone turnover in a subset of patients at day seven and months three, six and 12. Statistical non-inferiority tests will explore the comparable efficacy of the two drugs. Adverse events will be monitored throughout the study.

About Bonviva

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

· Once-daily Bonviva is indicated for the treatment and prevention of osteoporosis in postmenopausal women by reduction of elevated bone turnover, increasing bone mineral density and reduction of 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.9

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

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

· Bonviva (known in the USas Boniva), was approved by the US Food and Drug Administration in March 2005. In the US, Boniva 150mg is indicated for the prevention and treatment of osteoporosis in postmenopausal women.

· Bonviva received European Union approval in September 2005 and Swissmedic approval in August 2005. In Europeand Switzerland, Bonviva 150mg is indicated for the treatment of osteoporosis in postmenopausal women.

About Post Menopausal Osteoporosis

Bone is constantly being rebuilt and goes through a balanced process of bone break-down and new bone formation. After menopause, this balance is disrupted and women loose bone faster than it is rebuilt. This imbalance can be easily measured by simple blood or urine tests. After years of bone loss, bones become brittle and more likely to break. The goal of osteoporosis treatment is to restore the bone balance hence increasing bone mass and consequently decreasing the risk of osteoporotic fractures.

· Osteoporosis affects an estimated 75 million people in Europe, USAand Japan.10

· 1/3 of women over 50 will experience osteoporotic fractures. 10

· Osteoporosis is a common and chronic condition. 10

· Like many chronic conditions, over half of all patients prescribed daily or weekly osteoporosis treatment stop taking their medicine within 12 months.2,5,11

· This insufficient adherence to treatment can result in increased risk of further fractures.5,11,12

· Taking medication less often can assist patients to stay on their therapy.11,13

· The cost to healthcare systems worldwide as a result of osteoporotic fractures is estimated to be in the billions of dollars each year.10

· The prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. 10

· An estimated 52 million women aged fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020. 10

Roche/GSK Collaboration

In December 2001, Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonivafor 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 market leader in virology. For further information http://www.roche.com

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.

Further information:

Roche Healthkiosk, Osteoporosis: health-kiosk.ch/start_osteo.htm

GSK website: http://www.gsk.com

Roche Media Relations Global Contact:
Elisabeth Day
International Communications Manager
Roche, Basel
Mobile: +41 79 597 2054

GlaxoSmithKline Contacts:
UKMedia enquiries:
Philip Thomson
(020) 8047 5502
David Mawdsley
(020) 8047 5502
Chris Hunter-Ward
(020) 8047 5502
Alice Hunt
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European Analyst/Investor enquiries:
Duncan Learmouth
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Anita Kidgell
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Jen Hill
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References

1. Emkey R, Binkley N, Seidman L, et al . BALTO I: Women Treated 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, USA23 - 27 September 2005.
2. DIN-LINK data, Compufile Ltd, January 2004. NB. Patients are excluded from the analysis at the point where they stop taking therapy altogether or have failed to comply fully.
3. Sebaldt R, Shane L, Pham B, 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)
4. Chestnut et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research, vol.10: 8, 2004
5. Data on file, NDC Health Study. (Ref. 161-011), Hoffman-La Roche Inc, Nutley, NJ.
6. Eastell R et al. Calcif tissue Int 2003; 72:408 (Abstract P-297)
7. Mc Clung MR, Drezner MK, Reginster J-Y 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, USA23 - 27 September 2005.
8. Lewiecki EM, Emkey R, Adami S, Rowell L, Mairon N et al. Once-Monthly Oral Ibandronate Is Safe And Well Tolerated In Women With Postmenopausal Osteoporosis: MOBILE 2-Year Analysis. Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research, Nashville, USA23 - 27 September 2005.
9. Cosman F, McClung M, Rosen C Epstein S, Devas V, El Azzouzi B, Bonvoisin B, Zanchetta J, Cooper C, Delmas PD. Rationale And Design of The MOTION Study (Monthly Oral Therapy With Ibandronate For Osteoporosis Intervention). Abstract presented at 27th Annual Meeting of the American Society for Bone Mineral Research, Nashville, USA23-27 September 2005.
10.International Osteoporosis Foundation.
11.Ettinger M, Gallagher R, Amonkar M, et al. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum 2004; 15 (Suppl):S513 (Abstract 1325).
12.McCombs JS, Thiebaud P, McLaughlin-Miley C, et al. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-87.
13.Cramer JA, Amonkar MM, Hebborn A, Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy amongst postmenopausal osteoporotic women? J Bone Miner Res 2004; 19 (Suppl. 1):S448 (Abstract M434).

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