Amgen announces positive denosumab results

Amgen has announced positive top-line results from a phase III clinical trial of denosumab as a treatment for bone loss in men with non-metastatic prostate cancer who are undergoing androgen deprivation threapy.

The study met its primary endpoint of increases in bone mineral density at the lumbar spine and also met the secondary endpoint of new vertebral fracture reduction.

Improvements in bone mineral density were consistent with the results of other studies of the compound in post-menopausal women with low bone mass and breast cancer patients receiving aromatase inhibitor therapy.

Denosumab is a fully human monoclonal antibody that targets Rank Ligan, the regulator of cells that break down bone known as osteoclasts.

Roger Perlmutter, executive vice-president of research and development at Amgen, said: “This pivotal study in men with prostate cancer demonstrated once again that denosumab increases bone mineral density.”

He added the company was excited about the reduction observes in vertebral fractures, which indicates the increased bone mineral density seen in patients is associated with enhanced bone strength.

In May 2008, Amgen said bone density is increased in post-menopausal women who take denosumab, compared to those that continue with alendronate.