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| |  Denosumab Increases Bone Density, Reduces Fracture Risk in Prostate Cancer Survivors BOSTON -- August 11, 2009 -- Twice-yearly treatment with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, will appear early online and in the August 20 New England Journal of Medicine. "Androgen-deprivation therapy is the standard treatment for men with locally advanced, recurrent, and metastatic prostate cancer; but many active men who have been successfully treated for their cancer develop debilitating bone fractures as a result," said Matthew Smith, MD, PhD, Massachusetts General Hospital (MGH) Cancer Center and Harvard Medical School, Boston, Massachusetts, who led the study as part of the Denosumab HALT Prostate Cancer Study Group. "The results of this study should be critically important in improving the quality of life of thousands of prostate cancer survivors." About one-third of the 2 million prostate cancer survivors in the United States currently receive androgen-deprivation therapy. Several medications used to treat osteoporosis, including bisphosphonates, have been shown to reduce androgen-deprivation-related bone loss in men in earlier small clinical studies, but none of those trials were adequate to demonstrate reduced fracture risk. In the phase 3 trial, men undergoing androgen-deprivation therapy for nonmetastatic prostate cancer were enrolled at 156 centres in North America and Europe and randomly assigned to receive injections of either denosumab or a placebo every 6 months for 3 years. Participants were also instructed to take daily calcium and vitamin D supplements during the study period. Among the more than 900 participants who completed the study, denosumab significantly increased bone density at all the monitored sites -- including the lumbar spine, total hip, and femoral neck -- and reduced new vertebral fractures by 62%. Bone density at the radius also increased in the treatment group, an improvement not seen with other osteoporosis drugs. Few adverse events were associated with treatment, and there were no reports of osteonecrosis of the jaw, a problem reported in some patients taking bisphosphonates. "Denosumab is an important new therapy to prevent painful fractures in prostate cancer survivors," Dr. Smith said. "An ongoing clinical trial will also evaluate whether denosumab prevents spread of prostate cancer to bone, the most common site of metastases in men with this disease." Denosumab -- a fully human monoclonal antibody that blocks the action of osteoclasts -- is also being investigated to prevent fractures in women with osteoporosis. SOURCE: Massachusetts General Hospital
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