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| |  Experimental Drug Reduces Fractures Related to Prostate Cancer Treatment: Presented at ASBMR By John Otrompke DENVER -- September 15, 2009 -- An experimental drug called denosumab demonstrates promising results in reducing fractures and improving bone health in patients being treated for prostate cancer, according to study research presented here at the 31st Annual Meeting of the American Society for Bone and Mineral Research (ASBMR). “Androgen-deprivation therapy is used in prostate cancer patients, and it may be responsible for increased fracture risk because the testosterone is converted to oestrogen, which nourishes the bone,” explained coauthor Carsten D. Goessl, MD, Amgen, Thousand Oaks, California, presenting findings here at a poster session on September 12. “Denosumab was associated with a 91% reduction in bone markers compared with placebo,” noted Dr. Goessl. The phase 3 clinical trial examined 6 fasting bone-turnover markers produced by the bones as they break down. 1 C-telopeptide, tartrate-resistant alkaline phosphatase 5b, and the bone formation marker N-terminal propeptide type I procollagen were measured at baseline and 1 month post dose, and predose at months 6, 12, 24, and 36. Eligible subjects 70 years of age and older could not be severely osteoporotic; those under 70 years of age had to have had prior fractures. In this study, 1,468 patients were randomised to receive either denosumab 60 mg subcutaneously every 6 months (n = 679), or placebo (n = 673) for 36 months. All subjects also received supplemental calcium and vitamin D. Denosumab reduced the incidence of vertebral fractures by 62% over 3 years in certain patients with prostate cancer. Denosumab also increased bone mineral density at all measured skeletal sites and reduced the incidence of new fractures at any site by 28% over the 36 months. In the placebo arm, fractures occurred in 3.9% of patients over 3 years, compared with 1.5% in those patients who received denosumab. “It looks like the drug has the strongest effect about 1 month after taken, then it weans off a little bit before the next dose,” Dr. Goessl explained. There were slightly more serious adverse events in the patients who received denosumab than in those who did not, with 35% of those in the treatment arm experiencing serious adverse events, compared with 31% in the placebo arm. Arrhythmias were experienced by 2.6% of patients in the treatment arm, compared with 2.1% of subjects in the placebo arm. Dyspnoea was experienced by 1.1% of the treatment population, compared with 0.4% of those in the placebo arm. Interestingly, however, bone metastasis occurred in only 0.4% of patients in the treatment arm, compared with 1.4% of those in the placebo arm. Deaths in this study remained constant, with 6% of patients in each arm dying during the course of the study. Funding for this study was provided by Amgen. [Presentation title: Effects of Denosumab on Bone Turnover Markers in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Abstract SA0115]
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