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| |  Denosumab Suppresses Bone Remodelling and Increases Bone Mineral Density Better Than Alendronate: Presented at ASBMR By Louise Gagnon MONTREAL -- September 18, 2008 -- Use of denosumab in treatment-naïve, postmenopausal women with low bone-mineral density (BMD) produces superior results in surrogate markers of osteoporosis compared with conventional bisphosphonate therapy, according to a phase 3 extension study presented here American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting. "Denosumab showed a greater increase [in BMD] at all skeletal sites as well as a greater reduction in bone turnover markers," said lead investigator Jacques Brown, MD, Université Laval and Centre Hospitalier Universitaire de Québec, Quebec City, Quebec. Patients treated with denosumab had a greater response to treatment with denosumab in terms of reduction of bone modelling compared with patients treated with alendronate, said Dr. Brown in an interview following his oral presentation on September 16. Women enrolled in the study were randomised in a 1:1 design to receive subcutaneous denosumab injections of 60 mg every 6 months and an oral placebo weekly or 70 mg weekly of oral alendronate and a subcutaneous placebo injection every 6 months. Patients also received calcium and vitamin D supplements. The researchers randomised 594 women to denosumab injections and 595 to alendronate injections. The women were a mean of 64 years old and had a mean lumbar spine T score of -2.6. They were evaluated at 1 month, 6 months, and 1 year for serum C-telopeptide, procollagen type 1 N-propeptide, and bone mineral density. Patients who underwent denosumab injections achieved decreases in serum C-telopeptide of 89% at 1 month, 77% at 6 months, and 74% at 1 year, while women in the alendronate group had decreases of 61%, 73%, and 76%, respectively. The differences between arms were highly statistically significant at 1 month and 6 months (P <= .0001). Median reductions in procollagen type 1 N-propeptide at the same time points for the denosumab group were 26%, 72%, and 72%, while for the alendronate group the reductions were 11%, 62%, and 65%. The differences between treatment arms were highly statistically significant at all intervals. There was no significant difference in adverse events between patients in the study arms, Dr. Brown noted. "Regardless of the bone remodelling state at baseline, you do see a significantly greater increase in the denosumab than alendronate treatment group at the BMD level," Dr. Brown said. "Physicians don't have to ask themselves if they are treating a low or high [level of bone] remodelling patient when they choose treatment. You do receive a better response using denosumab." He said the results suggest denosumab is a more potent drug than alendronate in its impact on bone remodelling. Funding for this study was provided by Amgen Inc.
[Presentation title: Effect of Denosumab vs Alendronate on Bone Turnover Markers and Bone Mineral Density Changes at 12 Months Based on Baseline Bone Turnover Level. Abstract 1285]
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