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FDA approves osteoporosis drug for men

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The FDA recently approved a once-yearly zoledronic acid injection for the treatment of osteoporosis in men.

The approval was based on results of a two-year, double-blind, head-to-head trial trial in over 300 men with osteoporosis to determine the safety and efficacy of a zoledronic acid injection (Reclast, Novartis) to oral weekly bisphosphonate. The researchers assigned 153 participants to a 15-minute infusion once-yearly and assigned 148 participants to an active control bisphosphonate weekly for two years.

The zoledronic acid injection increased lumbar spine bone mineral density in men with osteoporosis by 6.1% during two years, according to a press release. Further, the drug was non-inferior to the active control.

“Fracture from osteoporosis can have serious debilitating consequences yet this silent epidemic is under-diagnosed and undertreated, especially in men,” Felicia Cosman, MD, professor of clinical medicine at Columbia University in N.Y., said in a press release.

“I am encouraged that more patients will now be able to benefit from a full year’s treatment with a single annual 15-minute infusion, helping to protect them against osteoporotic fractures,” she added.