Zoledronic acid cuts vertebral fracture risk 67% in men with osteoporosis



Annual infusions of zoledronic acid significantly decreased the risk of new morphometric vertebral fractures by 67% in men who had osteoporosis, according to an industry-sponsored clinical trial published online Oct. 31 in the New England Journal of Medicine.

In a 2-year double-blind study conducted in Europe, South America, Africa, and Australia, 553 men with osteoporosis were randomly assigned to receive once-yearly infusions of 5 mg zoledronic acid and 574 were assigned to receive placebo infusions. Only the active drug produced significant and sustained increases in bone mineral density at the lumbar spine, total hip, and femoral neck, and it did so across all levels of serum testosterone, said Dr. Steven Boonen of the Center for Metabolic Bone diseases and the division of geriatric medicine, University Hospitals Leuven (Belgium), and his associates.

Only 1.6% of the men receiving zoledronic acid developed new vertebral fractures, compared with 4.9% of those receiving placebo, a difference that corresponded with an absolute risk reduction of 3.3 percentage points and a relative risk reduction of 67%. This reduction is similar to that seen in women with osteoporosis who receive zoledronic acid, suggesting that the antifracture effect of the drug is independent of patient sex, the investigators said (N. Engl. J. Med. 2012 Oct. 31 [doi:10.1056/NEJMoa1204061]).

Now that an effective treatment has been identified for men with osteoporosis, public health efforts to detect the disease and prevent fractures in the male population, which have been inadequate to date, can be stepped up, Dr. Boonen and his colleagues added.

This study was funded by Novartis Pharma, maker of zoledronic acid. The authors reported numerous ties to industry sources.

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