Fracture Prevention with Zoledronate in Older Women with Osteopenia

Study answer

What this study found

Zoledronate reduced fragility fracture risk over 6 years (first fracture): 122/1000 vs 190/1000 in placebo (hazard ratio 0.63; 95% CI 0.50–0.79; P<0.001); number needed to treat to prevent one fracture = 15. 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); height loss reduced (P<0.001). Death and cancer risks did not increase; hip fracture risk not significantly different. Conclusion: In older women with osteopenia, zoledronate every 18 months for 6 years lowers the risk of fragility fractures and supports use…

Study & population

Randomized, double-blind, placebo-controlled trial; 2000 ambulatory postmenopausal women aged ≥65 with osteopenia (T score −1.0 to −2.5 at the total hip or femoral neck on either side); recruited from electoral registers in Auckland, New Zealand; followed for 6 years.

Intervention

Zoledronate 5 mg intravenous infusion, four infusions at 18-month intervals over 6 years; dietary calcium intake advised at 1 g/day (calcium supplements not provided); cholecalciferol (Vitamin D3) supplementation for participants not already taking vitamin D: 2.5 mg before the first infusion and 1.25 mg per month…

Key limitation

Limitations include generalizability limited to ambulatory postmenopausal women aged ≥65 with osteopenia; not powered to assess rare adverse events such as osteonecrosis of the jaw or atypical femoral fractures; prespecified secondary endpoints not adjusted for multiplicity; some placebo participants started…

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Original abstract