Positive Top-line Results For Treatment Of Bone Loss In Men With Non-Metastatic Prostate Cancer Undergoing Androgen Deprivation

Amgen announced findings from a three-year pivotal Phase 3 placebo-controlled trial evaluating denosumab in the treatment of bone loss in men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer. In this study of more than 1,400 men, denosumab treatment produced statistically significantly greater increases in bone mineral density (BMD) 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. During the 36-month evaluation period, men receivin...