Amgen’s Phase III Prolia Study Checks off All Endpoints at 12 Months

Amgen published positive results from a Phase III trial comparing Prolia (denosumab) with risedronate in patients receiving oral glucocorticoid therapy. The study met all primary and secondary endpoints at 12 months.

The data showed that Prolia treatment led to significantly greater gains in bone mineral density at the lumbar spine and total hip, both in patients receiving continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy.

A total of 795 patients enrolled in the 24-month study, receiving 60 mg of Prolia subcutaneously every six months, compared with oral risedronate at 5 mg daily. Further analysis is ongoing, and Amgen plans to submit results to a future medical conference. The study remains double-blinded for an additional 12 months.