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QUESTION: In postmenopausal women with osteoporosis and ≥1 vertebral fracture, does alendronate reduce back pain and functional limitation caused by back pain?
Design
3 year randomised {allocation concealed*}†, blinded {patients, clinicians, and outcome assessors}†*, placebo controlled trial (Fracture-Intervention Trial [FIT]).
Setting
11 clinical centres in the US.
Patients
2027 women who were 55–81 years of age (mean age 71 y), had been postmenopausal for ≥2 years, had a femoral neck bone mineral density ≤0.68 g/cm2, and had ≥1 vertebral fracture. Follow up was 100%.
Intervention
Women were allocated to alendronate sodium, 5 mg/day for 2 years and 10 mg/day for the third year (n=1022), or placebo (n=1005).
Main outcome measures
Days of back pain and limited activity days related to back pain were assessed by questionnaire every …