In this one-year, non-pivotal study, denosumab treatment achieved significantly greater BMD gains at the total hip, hip trochanter and distal radius compared with alendronate. For the primary endpoint, the relative magnitude of BMD improvement at the total hip was approximately 40 percent greater in the denosumab versus the alendronate group. The changes in BMD in the alendronate group were consistent with previously reported studies.
The incidence and types of adverse events observed in this study were similar between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were arthralgia, back pain, constipation and dyspepsia.
"We are very encouraged by the results of this head-to-head study directly comparing denosumab with alendronate, a widely used osteoporosis treatment," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The complete analysis of data from this trial will be presented in a peer-reviewed forum later this year. In addition, we are looking forward with great anticipation to the results of our large, pivotal Phase 3 registrational study evaluating the ability of denosumab to reduce fracture risk in women with post-menopausal osteoporosis.
A total of 1,189 women with postmenopausal osteoporosis were randomized 1:1 to receive denosumab or alendronate and followed for one year to assess changes in BMD. The study primary endpoint was to evaluate the effect of denosumab on percent change from baseline in BMD at the total hip compared to alendronate. Secondary endpoints were to evaluate the effect of denosumab on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck and distal radius compared to alendronate.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential mediator of osteoclasts (the cells that break down bone). Denosumab inhibits all stages of osteoclast activity through a targeted mechanism that does not incorporate into bone matrix. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis, rheumatoid arthritis, cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
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