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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

dicine and the director of Genitourinary Medical Oncology at Massachusetts General Hospital Cancer Center. "In this large international study, denosumab markedly increased bone mineral density and decreased the risk of fractures in many men receiving androgen deprivation therapy for prostate cancer. The efficacy of denosumab was apparent as early as one month and was sustained for three years."

In the HALT trial, the overall incidence and type of side effects with denosumab were similar to placebo. Rates of AEs were similar in both groups (87 percent). Rates of serious AEs were 35 percent for denosumab and 31 percent for placebo. The most common AEs across both treatment arms were arthralgia, back pain, constipation, pain in extremity, and hypertension. There were no reported cases of osteonecrosis of the jaw among patients treated with denosumab. More patients receiving denosumab developed cataracts, though none were considered treatment-related. One patient in the denosumab arm developed hypocalcemia, versus none in the placebo arm. New primary malignancies were reported in 5 percent of patients in each group. Serious AEs of infections were reported in 6 percent of denosumab-treated patients and in 5 percent of placebo-treated patients.(2)

"Amgen scientists in the 1990s were the first to identify the RANK Ligand pathway, a pivotal physiologic mechanism that controls bone remodeling," said Roger Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Today's publications in the New England Journal of Medicine underscore the significance of this finding, and highlight Amgen's focus on using innovative research to address grievous illness."

About Denosumab

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 do
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SOURCE Amgen Inc.
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