Study Presents Potential New Option For Treatment Of Bone Loss

Amgen has announced the publication of results from two pivotal phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk, in The New England Journal of Medicine (NEJM).

The study was conducted on more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer, undergoing androgen deprivation therapy (ADT) leading to bone loss. In both the studies, patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD), as compared to placebo, associated with more than 60% reduction in vertebral fracture in both patient populations.

Steven Cummings, lead investigator, study author, and director of the San Francisco Coordinating Center of the California Pacific Medical Center Research Institute, said: These results suggest that denosumab offers a new approach to prevention of fractures in women with postmenopausal osteoporosis. It reduces the risk of all major types of fractures and, because it is given as an injection twice a year, it also has the potential to help compliance to treatment.

Results from the FREEDOM study showed that women receiving a subcutaneous shot of denosumab twice-yearly experienced a 68% reduction in the risk of suffering a vertebral fracture, compared to those receiving placebo, as well as a 40% reduction in the risk of suffering a hip fracture and a 20% reduction in the risk of suffering a nonvertebral fracture.

Results from the HALT study in 1,468 men undergoing ADT for non-metastatic prostate cancer showed that patients treated with denosumab experienced a 62% reduction in the risk of suffering a new vertebral fracture, as compared to placebo at 36 months, with significant reduction observed as early as month 12.