Fracture Prevention with Infrequent Zoledronate in Women 50 to 60 Years of Age
Authors' conclusion
Ten years after trial initiation, zoledronate administered at baseline and 5 years was effective in preventing morphometric vertebral fracture in early postmenopausal women.
Study context
- Population
- Early postmenopausal women (50 to 60 years) with BMD T scores lower than 0 and higher than −2.5 at the lumbar spine, femoral neck or hip1,003 (95.2%) completed 10 years
- Participants
- 1,054 women
- Comparison
- Zoledronate 5 mg at baseline and 5 years, or at baseline then placebo at 5 years, vs placebo at both
- Primary endpoint
- Morphometric vertebral fracture (≥20% change in vertebral height from baseline radiograph, assessed semiquantitatively)
- Follow-up
- 10 years
Methodological detailsdouble-blind, placebo-controlled, prospective, 10-year
- Double-blind
- Placebo-controlled
- Prospective
- 10-year
Primary result
As reported in the abstract
New morphometric vertebral fracture
Each group vs placebo-placeboRelative risk (95% CI)P value
Zoledronate-zoledronate
0.56(0.34–0.92)
P = 0.04Zoledronate-placebo
0.59(0.36–0.97)
P = 0.08Secondary outcomes
| Outcome | RR (95% CI) | |
|---|---|---|
| Fragility fractureZoledronate-zoledronatevs Placebo-placebo | 0.72 (0.55–0.93) | |
| Fragility fractureZoledronate-placebovs Placebo-placebo | 0.79 (0.61–1.02) | |
| Any fractureZoledronate-zoledronatevs Placebo-placebo | 0.70 (0.56–0.88) | |
| Any fractureZoledronate-placebovs Placebo-placebo | 0.77 (0.62–0.97) | |
| Major osteoporotic fractureZoledronate-zoledronatevs Placebo-placebo | 0.60 (0.42–0.86) | |
| Major osteoporotic fractureZoledronate-placebovs Placebo-placebo | 0.71 (0.51–0.99) | |
| 0.512Relative risk (log scale) |
Original publication
Fracture Prevention with Infrequent Zoledronate in Women 50 to 60 Years of Age. N Engl J Med. Published 16 January 2025. doi:10.
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