You are here
The NEJM reports that zolendronic acid was shown to significantly lower the risk of nonvertebral or vertebral fragility fractures in older women with osteopenia.
A 6-year, double-blind controlled trial involved 2000 women >65 years old with osteopenia (T score −1.0 to −2.5 at hip or femoral neck) who were randomized to receive four infusions of either zoledronate 5 mg or normal saline (placebo) at 18-month intervals. No additional calcium supplements were provided on top of their normal dietary calcium intake (~1 gr/day). The primary endpoint was the time to first occurrence of a nonvertebral or vertebral fragility fracture.
Older women (mean age: 71±5 years) had a baseline femoral neck T score of −1.6±0.5 and the median 10-year risk of hip fracture of 2.3%.
At the end of 6 years, the overall fragility fracture rate was lower in the zoledronate treated patient (HR 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001). The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15.
Overall, women treated with zoledronate had a lower risk of nonvertebral fragility fractures (HR 0.66; P=0.001), symptomatic fractures (HR 0.73; P=0.003), vertebral fractures (OR 0.45; P=0.002), and height loss (P<0.001).
There were no atypical femoral fractures or cases of osteonecrosis of the jaw reported in either group. But there was a lower rate of certain adverse events, including cancer (OR 0.67; 95% CI, 0.50 to 0.89), myocardial infarction (OR 0.61), and death (OR 0.65; 95% CI, 0.40 to 1.05), in patients on zolendronic acid.
These data attest to the benefits of zolendronic acid given every 18 months for 6 years with a reduced fracture risk when given to elderly women with osteopenia only. Prior to this study, there was limited evidence about the benefits of treating elderly at risk women with osteopenia only.