Amgen is publishing positive data today for its closely watched Phase III trial of denosumab for the treatment of bone loss in men undergoing androgen deprivation therapy for non-metastatic prostate cancer. Researchers say that in the study of 1,400 men, denosumab "produced statistically significantly greater increases in bone mineral density at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points. These improvements in BMD were consistent with those seen in other denosumab studies evaluating BMD in women with breast cancer receiving aromatase inhibitor therapy, and in post-menopausal women with low bone mass."
"We are also excited by the reduction in vertebral fractures, which permits the conclusion that the increased BMD seen in patients receiving denosumab is associated with improved bone strength," said Roger Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "We are encouraged by the potential benefit this may represent to prostate cancer patients undergoing ADT for whom bone loss and fractures are serious and under-recognized complications of cancer treatment."
- read Amgen's release
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