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Once-a-year Drug Reduces Fractures from Osteoporosis

ten a problem, so an annual treatment means patients are far more likely to actually receive valuable protection against potentially devastating fractures."

Postmenopausal osteoporosis affects millions of women worldwide, Black said, including more than 50 million women in the United States, Europe and Japan combined. Half of those women over age 50 will suffer from an osteoporotic fracture in their lifetime and, of women over age 65 who fracture a hip, 21 percent will die within one year as a result of poor underlying health status, in addition to the acute effects of the fracture.

The study, formally called Health Outcomes and Reduced Incidence with Zoledronic acid Pivotal Fracture Trial, known as HORIZON, was a multinational, randomized, placebo-controlled trial. It evaluated the potential of using a once-yearly infusion of 5 mg of zoledronic acid to decrease the risk of vertebral and hip fractures in postmenopausal women with osteoporosis.

The study also closely examined and put to rest several questions of other side effects of zoledronic acid, such as the renal damage and bone deterioration that has been seen at much larger doses in oncology treatments. The HORIZON study showed no such findings at the lower dose required for osteoporosis treatments.

The study did observe a small increase in the incidence of atrial fibrillation in patients who received zoledronic acid (1.3 percent for zoledronic acid versus 0.5 percent for placebo). Atrial fibrillation is a condition of abnormal heart rhythms, which is one risk factor for stroke.

"The observed increase in atrial fibrillation was very small less than one in 100 patients so it needs to be weighed against the reduction in fracture risk," Black said. This increase was unexpected and has not been seen in other studies of zoledronic acid. He recommends that it be further examined.

The May 3 issue of "NEJM" also includes a letter reg
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