Amgen releases results of bone loss trial

THOUSAND OAKS, Calif. Amgen on Tuesday announced the publication of results from two pivotal phase 3 studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with nonmetastatic prostate cancer undergoing androgen deprivation therapy leading to bone loss.

In both studies, published Aug. 11 in The New England Journal of Medicine, patients receiving twice-yearly denosumab experienced significant increases in bone mineral density compared with placebo, associated with more than 60% reduction in vertebral fracture in both patient populations.

“The discovery of the RANK Ligand pathway represents a significant advance in the understanding of bone biology,” stated Roland Baron, professor and chair of department of Oral Medicine, Infection and Immunity at the Harvard School of Dental Medicine. “These results demonstrate that targeting the RANK Ligand pathway with denosumab could represent a promising new approach in two different disease settings characterized by bone loss.”