Amgen’s Bone Loss Drug and Prostate Cancer

The results of 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, showed positive top-line results.

Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone).

Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease.

Such were the findings recently reported by Amgen, Inc –maker of the bone loss drug denosumab.

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.

Loss in bone mineral density and fractures are conditions induced by the hormone-blocking therapy that men with non-metastatic prostate cancer has to go through.

While this bone loss drug could be the answer to that problem…I’m pretty sure it has side-effects. Let’s wait and see what the FDA has to say. This is a Phase 3 clinical trial already, so that means it won’t be long until this gets approved for marketing and use in patients. We’ll see…