FDAnews
www.fdanews.com/articles/108984-amgen-drug-meets-endpoints-in-osteoporosis-trial

Amgen Drug Meets Endpoints in Osteoporosis Trial

July 29, 2008

Amgen’s denosumab met its primary and secondary endpoints for a Phase III trial evaluating it as a treatment of postmenopausal osteoporosis.

In the three-year, international study of roughly 7,800 women with osteoporosis, patients were randomized to receive either denosumab or placebo injections. Compared with placebo, patients on the drug had fewer incidences of new vertebral, nonvertebral and hip fractures, Amgen said.

The most common adverse events across both treatment arms were arthralgia, back pain, hypertension and the common cold.