New Medicine Option for Men with Osteoporosis Approved

The FDA approved a new indication for the use of the osteoporosis medicine, Prolia® (denosumab): “Treatment to increase bone mass in men with osteoporosis at high risk for fracture.”

With this approval five osteoporosis medicines are approved for use in men: Fosamax® (alendronate), Actonel® (risedronate), Reclast® (zoledronic acid),  Forteo® (teriparatide), and Prolia® (denosumab).

Prolia is a treatment for osteoporosis that was first approved by the FDA in 2010 for use in women with osteoporosis who are high risk for fracture. Prolia decreases bone turnover by a different mechanism of action than the other FDA-approved medicines for osteoporosis. Prolia is given by shot under the skin twice a year in your doctor’s office.

The FDA approved the new indication for men based on a 12-month clinical trial named the ADAMO study. ADAMO stands for 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. A total of 242 men average age 65 with osteoporosis received a shot of Prolia or placebo solution under the skin once every six months for one year (a total of two shots). Bone density increases in the Prolia group were consistent with the results obtained in studies with women. Prolia was safe and effective in improving bone density in men subjects over 12 months.

In the United States, nearly 30% of all broken bones that occur in individuals over the age of 50 are in men. The death rate after hip fracture is higher in men than in women. Osteoporosis in men is not appropriately diagnosed and treated. An estimated 2 million men have osteoporosis in the US and another 12 million are at risk. Are you or your loved one?

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Amgen news release
ADAMO Study: Orwoll E et al. JCEM 2012 97: 3161-3169; doi:10.1210/jc.2012-1569