Fracture Prevention with Infrequent Zoledronate
Trial question
What is the effect of zoledronate for fracture prevention in early postmenopausal women?
Study design
Multi-center
Double blinded
RCT
Population
703 female patients.
Inclusion criteria: early postmenopausal women, aged 50-60 years, with bone mineral density T scores < 0 and > -2.5 at the lumbar spine, femoral neck, or hip.
Key exclusion criteria: bone mineral density T score < -2.5 at the total hip, femoral neck or lumbar spine; renal impairment; untreated hypothyroidism or hyperthyroidism; chronic liver disease; concurrent major systemic illness; metabolic bone diseases; previous fragility fracture of the hip or spine.
Interventions
N=352 zoledronate (infusion of zoledronate at a dose of 5 mg at baseline and at 5 years).
N=351 placebo (matching placebo at baseline and at 5 years).
Primary outcome
Morphometric vertebral fracture at 10 years
6.3%
11.1%
11.1 %
8.3 %
5.5 %
2.8 %
0.0 %
Zoledronate
Placebo
Significant
decrease ▼
NNT = 20
Significant decrease in morphometric vertebral fracture at 10 years (6.3% vs. 11.1%; RR 0.56, 95% CI 0.34 to 0.92).
Secondary outcomes
Significant decrease in fragility fracture (20.2% vs. 28.2%; RR 0.72, 95% CI 0.55 to 0.93).
Significant decrease in any fracture (24.7% vs. 35.3%; RR 0.7, 95% CI 0.56 to 0.88).
Significant decrease in major osteoporotic fracture (11.6% vs. 19.7%; RR 0.6, 95% CI 0.42 to 0.86).
Safety outcomes
No significant difference in adverse events.
Conclusion
In early postmenopausal women, aged 50-60 years, with bone mineral density T scores < 0 and > -2.5 at the lumbar spine, femoral neck, or hip, zoledronate was superior to placebo with respect to morphometric vertebral fracture at 10 years.
Reference
Mark J Bolland, Zaynah Nisa, Anna Mellar et al. Fracture Prevention with Infrequent Zoledronate in Women 50 to 60 Years of Age. N Engl J Med. 2025 Jan 16;392(3):239-248.
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