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Amgen Reports Positive Results for Treatment of Bone Loss in Cancer Study

Posted on: Tuesday, 15 July 2008, 12:01 CDT

Amgen has reported positive results from a three-year pivotal Phase III placebo-controlled trial evaluating denosumab in the treatment of bone loss in men undergoing androgen deprivation therapy 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 receiving denosumab experienced less than half the incidence of new vertebral fractures (a secondary endpoint) compared with those receiving placebo, a statistically significant finding. Furthermore, in the denosumab arm there were fewer non-vertebral fractures over the 36-month period.

Roger Perlmutter, executive vice president of R&D at Amgen, said: "We are encouraged by the potential benefit this may represent to prostate cancer patients undergoing androgen deprivation therapy for whom bone loss and fractures are serious and under-recognized complications of cancer treatment."

Source: Datamonitor

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