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The NEJM reports that the use of zoledronate significantly reduces the risk of nonvertebral or vertebral fragility fractures in women with osteopenia.
While it is known that bisphonates have beneficial effects in osteoporosis, their impact in osteopenia has not been shown.
A 6-year, double-blind trial involving 2000 elderly women (>65 yrs) with osteopenia (T score −1.0 to −2.5)in the hip or femoral neck were randomized to receive four infusions of zoledronate (5 mg) or saline (placebo group) at 18-month intervals. The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture.
The baseline age was 71±5 years, T score was −1.6±0.5, and the 10-year risk of hip fracture was 2.3%.
A fragility fracture occurred in 190 women in the placebo group and in 122 women in the zoledronate group (hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001).
The NNT to prevent a fracture in 1 woman was 15.
Women treated with zoledronate had a lower risk of nonvertebral fragility fractures (hazard ratio, 0.66), symptomatic fractures (HR 0.73), vertebral fractures (OR 0.45) and height loss (P<0.001).
The bisphosphonate, zoledronate (zoledronic acid) is marketed by Novartis under the of Reclast.