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Denosumab increases bone density, cuts fracture risk in prostate cancer survivors
Date:8/11/2009

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 in the August 20 New England Journal of Medicine and is receiving early online release.

"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," says Matthew Smith, MD, PhD, of the Massachusetts General Hospital (MGH) Cancer Center, 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 two million prostate cancer survivors in the U.S. currently receive androgen-deprivation therapy, which blocks the release of testosterone. Several medications used to treat osteoporosis, including the drugs called 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. Denosumab a fully human monoclonal antibody that blocks the action of osteoclasts, the cells that break down bone in the normal process of bone remodeling is also being investigated to prevent fractures in women with osteoporosis. The current study was a Phase 3 trial supporting the application for FDA approval filed by Amgen Inc., the primary sponsor of the NEJM report.

Men undergoing androgen-deprivation therapy for nonmetastatic prostate cancer were enrolled at 156 centers in North America and Europe and rando
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Contact: Katie Marquedant
kmarquedant@partners.org
617-726-0337
Massachusetts General Hospital
Source:Eurekalert

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