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FDA approves once-yearly zoledronic acid injection
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A once-yearly zoledronic acid injection has been approved by the FDA for the prevention and treatment of osteoporosis for patients expected to be on glucocorticoids for at least 12 months.
The researchers reported that in a multinational, double-blind study, the once-yearly treatment with the zoledronic acid injection (Reclast, Novartis) was more effective than established therapy at increasing bone mass in patients with steroid-induced osteoporosis.
Eight hundred thirty-three men and women were enrolled in two treatment groups in the head-to-head study. The first group included those who had received high-dose glucocorticoid therapy for more than three months before the study began. The second group was a prevention group of patients who had received high-dose glucocorticoids for less than three months before the study began.
All patients agreed to stay on the therapy for 12 months.
According to a press release from Novartis, the results showed that Reclast increased bone mineral density at the lumbar spine significantly more than the active control during the 12-month period in both the treatment group (Reclast 4.1% vs. active control 2.7%; P<.001) and the prevention group (Reclast 2.6% vs. active control 0.6%; P<.001).
“Before today, the only approved options for patients on long-term glucocorticoid therapy were oral therapies,” Kenneth G. Saag, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham, said in the press release.
“Now they can be prescribed a single 15-minute infusion to prevent bone loss for a full year.”