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Studies Published in the New England Journal of Medicine Highlight Potential New Option in the Treatment of Bone Loss
Date:8/11/2009

enosumab twice-yearly experienced a 68 percent reduction in the risk of suffering a vertebral (spine) fracture compared to those receiving placebo as well as a 40 percent reduction in the risk of suffering a hip fracture and a 20 percent reduction in the risk of suffering a nonvertebral fracture. Over the three years of this multi-center, randomized, double-blind, placebo-controlled study, women treated with denosumab experienced significant increases in BMD (8.8 percent at the lumbar spine and 6.4 percent at the total hip).(1)

"These results suggest that denosumab offers a new approach to prevention of fractures in women with postmenopausal osteoporosis," said Steven Cummings M.D., lead investigator, study author, and director of the San Francisco Coordinating Center of the California Pacific Medical Center Research Institute. "It reduces the risk of all major types of fractures and, because it is given as an injection twice a year, it also has the potential to help compliance to treatment."

Fracture is one of the most common health events suffered by postmenopausal women with osteoporosis.(3) Globally, one woman in three over 50 years of age will experience a fracture in her lifetime.(3) A woman who has broken a bone as a result of osteoporosis has more than an eight- out-of-ten chance of breaking another bone.(4) Half of women who break a hip, a life changing event, will permanently need assistance to walk.(5)

The overall incidence and type of side effects with denosumab were similar to placebo in the FREEDOM study. Rates of adverse events (AEs) were similar in both groups (93 percent). Rates of serious AEs were 25.8 percent for denosumab and 25.1 percent for placebo. The most common AEs across both treatment arms were arthralgia, back pain, hypertension and nasopharyngitis. There were no reported cases of osteonecrosis of the jaw among patients taking denosumab. Serious adverse events of skin infections,
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SOURCE Amgen Inc.
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