← Evidence libraryFIT (alendronate)
Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group.
Black DM, Cummings SR, Karpf DB, et al. Lancet (London, England) 1996 · PMID 8950879 · doi:10.1016/s0140-6736(96)07088-2
Randomised trialManagementRheumatology & metabolic boneCitation checked
- Question
- Does oral alendronate reduce new fractures in postmenopausal women with low bone density and a prior vertebral fracture?
- Design
- Multicentre double-blind placebo-controlled RCT (vertebral fracture arm of the Fracture Intervention Trial).
- Patients
- Postmenopausal women with low femoral neck BMD and at least one existing vertebral fracture.
- Intervention
- Oral alendronate daily for about 3 years
- Comparison
- Placebo
- Primary outcome
- New morphometric vertebral fracture over about 3 years
- Key result
- Alendronate roughly halved new radiographic vertebral fractures and also significantly reduced hip and wrist fractures compared with placebo.
- Limitations
- Population restricted to women with established vertebral fractures; daily dosing used rather than the weekly regimen now standard; limited follow-up for long-term harms.
- Impact on practice
- Established oral alendronate as the first-line, low-cost treatment for osteoporosis, which remains the default in NOGG and NICE guidance.