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New Vertebral Fractures Reduced According to Phase 3 Trial of Denosumab
In this pivotal, three-year, international, Phase 3 study of approximately 7,800 women with osteoporosis, patients were randomized to receive either denosumab, given by subcutaneous injection once every six months, or placebo injections. For the primary endpoint, treatment with denosumab resulted in a statistically significant reduction in the incidence of new vertebral fractures compared with placebo treatment. In addition, women receiving denosumab experienced a statistically significant reduction in the incidence of new non-vertebral and hip fractures (each secondary endpoints) compared with those receiving placebo.
The incidence and types of both adverse and serious adverse events observed in this study, including serious infections and neoplasms, were similar between the denosumab and placebo groups. The most common adverse events across both treatment arms were arthralgia, back pain, hypertension and nasopharyngitis.
"Fracture is one of the most common health events a postmenopausal woman will suffer. Globally, one in three women over 50 will experience a fracture in her lifetime," said Dr. Ethel Siris, director of the Toni Stabile Osteoporosis Center at Columbia University Medical Center and immediate past president of the National Osteoporosis Foundation. "I am particularly excited about these findings because they indicate that denosumab may offer an important new option for patients."
"This long-awaited study demonstrated that denosumab treatment both increased bone mass and reduced the risk of skeletal fractures in women with postmenopausal osteoporosis," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "We are encouraged by the magnitude and consistency of the treatment effect and pleased with the safety results. At Amgen we are focusing our attention on ensuring that patients around the world will have access to this important therapeutic advance. We hope to have the opportunity to present the complete data set at the upcoming meeting of the American Society of Bone and Mineral Research in September."
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis, rheumatoid arthritis, and 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.