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| |  Patients Express Greater Satisfaction With Twice-Yearly Denosumab Than Alendronate: Presented at NAMS By John Otrompke SAN DIEGO -- October 4, 2009 -- More convenient administration of denosumab could increase compliance and improve patient results, according to a study presented here on October 2 at the 20th Annual Meeting of the North American Menopause Society (NAMS). In addition, denosumab exhibited marginally improved results compared with alendronate. In an oral presentation, David L. Kendler, MD, Clinical Resarch Centre, Vancouver, British Columbia, discussed two phase 3 trials comparing denosumab and alendronate. The Determining Efficacy: Comparison of Initiating Denosumab Versus Alendronate (DECIDE) study included 1,189 patients (mean age, 64 years) and the Study of Transitioning From Alendronate to Denosumab (STAND) trial included 504 patients (mean age, 68 years). Following 1 year of treatment after randomisation, bone mineral density (BMD) was compared at total hip, lumbar spine, and proximal radius, and patients also completed a satisfaction questionnaire. Participants in the STAND study were postmenopausal women who had taken oral alendronate therapy for at least 6 months immediately prior to screening. In both studies, patients were randomised to receive a 60 mg subcutaneous denosumab injection twice a year plus placebo, or 70 mg of alendronate given orally once a week, plus placebo. At the lumbar spine, denosumab was found to have 1.2% greater effect in the STAND trial, and 1.1% greater in DECIDE. At the total hip, the difference was 0.9% in STAND and 1% different in DECIDE, while at the radius the difference was 0.7% and 0.6%, respectively. However, patient satisfaction was more differentiated. Given the questionnaire, 93% of patients responded. In the denosumab arm, 64% of patients reported a preference for twice-yearly injections of denosumab, while 63% of patients in the alendronate arm reported a preference for the subcutaneous injections. “Adherence to alendronate is not very good, with more than 50% of patients discontinuing it in the first year of therapy,” Dr. Kendler said. Greater preference and satisfaction with the mode and schedule of administration may lead to increased persistence and compliance with therapy. More favourable patient medication taking behaviours together with significant gains in BMD could favourably impact fracture risk reduction. Funding for this study was provided by Amgen Inc. [Presentation title: BMD Results and Patient Preference and Satisfaction With Mode of Treatment Administration From 2 Phase 3 Trials Comparing Denosumab and Alendronate. Abstract S-4]
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