Successful Phase III trial of Prolia (denosumab) compared with risedronate in patients receiving glucocorticoid treatment.-Amgen

Amgen announced positive top-line results from the primary analysis conducted in a Phase III randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. The study met all primary and secondary endpoints at 12 months. The data showed that treatment with Prolia for 12 months, compared to risedronate, led to significantly greater gains in bone mineral density (BMD) at the lumbar spine and total hip, both in patients receiving continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy. Results from the glucocorticoid-induced osteoporosis (GIOP) study showed that, in patients receiving continuing glucocorticoid therapy, Prolia treatment led to greater gains in BMD, compared with risedronate, both at the lumbar spine (4.4 percent vs. 2.3 percent, respectively) and total hip (2.1 percent vs. 0.6 percent, respectively). Similarly, in patients newly initiating glucocorticoid therapy, Prolia treatment led to greater increases in BMD, compared with risedronate, both at the lumbar spine (3.8 percent vs. 0.8 percent, respectively) and total hip (1.7 percent vs. 0.2 percent, respectively). Adverse events (AEs) and serious adverse events (SAEs) were similar across treatment groups and consistent with the known safety profile of Prolia. No SAEs were reported with a subject incidence of two percent or greater in either treatment group.