Prolia meets endpoints in men with osteoporosis

Amgen Inc. (NASDAQ:AMGN) said Prolia denosumab met the primary endpoint of percent change from baseline in the lumbar spine bone mineral density (BMD) at month 12 vs. placebo in the Phase III ADAMO trial to treat men with osteoporosis. Prolia also met all secondary endpoints. The company said safety data were consistent with what has been previously reported in other populations. Amgen plans to submit the results to regulatory agencies in support of a label expansion for Prolia to include the indication. Details were not disclosed. ...