WEDNESDAY, Oct. 31 (HealthDay News) -- For men with osteoporosis, a once-yearly infusion with zoledronic acid is associated with fewer vertebral fractures and improved bone health compared with placebo, according to a study published in the Nov. 1 issue of the New England Journal of Medicine.
Steven Boonen, M.D., Ph.D., from the Katholieke Universiteit Leuven in Belgium, and colleagues investigated the effect of zoledronic acid on fracture risk in a multicenter, randomized trial involving 1,199 men with osteoporosis. Participants, aged 50 to 85 years, were randomly allocated to receive an intravenous infusion of either zoledronic acid or placebo at baseline and at 12 months. All participants received calcium and vitamin D each day and were followed for 24 months.
The researchers found that, over the 24-month period, the rate of any new morphometric vertebral fractures was 1.6 percent in the zoledronic acid group and 4.9 percent in the placebo group (relative risk, 0.33; P = 0.002). Men who received zoledronic acid had significantly fewer moderate-to-severe vertebral fractures and significantly less height loss compared with those receiving placebo. Fewer men in the zoledronic acid group had clinical vertebral or non-vertebral fractures, although due to the small number of fractures, this difference did not reach significance. Men who received zoledronic acid had higher bone mineral density and lower levels of bone-turnover markers.
"In conclusion, our prospective study that assessed fractures as the primary end point in men with osteoporosis showed that, over a two-year period, a once-yearly infusion of zoledronic acid at a dose of 5 mg was associated with a significant decrease in the risk of new vertebral fractures," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which funded the study and manufactures zoledronic acid.
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