Prolia Approved for Male Osteoporosis

Alert…men can have fragile bones too! To help out, Amgen has pushed forward, and is announcing the FDA approval of a new indication for their drug Prolia (denosumab). It can now be used as a treatment to increase bone mass in men with osteoporosis at high risk for fracture. Prolia, the first FDA-approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months.

“While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise, ” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, in the September 20, 2012 news release. “Fractures can be a life-changing event, so we are pleased that we can offer a new treatment option for the growing number of men with osteoporosis at high risk for fracture.”

The new indication for Prolia is based on results from the ADAMO trial3 (A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of DenosumAb 60 mg every six months versus placebo in Males with Osteoporosis), the pivotal Phase 3 study involving 242 men with low bone mineral density (BMD). In the study, treatment with Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo (5.7% vs. 0.9% ). Effects of Prolia on BMD were independent of age, baseline testosterone levels, BMD status and estimated fracture risk.

The researchers also found that patients in the study who received treatment with Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip and at the femoral neck. Safety findings were consistent with what have been observed in other studies of Prolia in postmenopausal women with osteoporosis. The most common adverse reactions reported were back pain, arthralgia and nasopharyngitis. The primary study endpoint was the percent change from baseline in the lumbar spine BMD at month 12. Secondary efficacy endpoints included percent change in total hip and femoral neck BMD from baseline to one year.