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QUESTIONS: In men with osteoporosis, does alendronate prevent or reverse bone loss, and does it decrease vertebral fractures?
Design
Randomised {allocation concealed*}†, blinded (patients and outcome assessors),* controlled trial with 2 year follow up.
Setting
20 centres in the US and 10 in other countries.
Patients
241 men (mean age 63 y) who met either of the following sets of criteria: bone mineral density (BMD) at the femoral neck ≥2 SDs below the mean value in normal young men and a BMD at the lumbar spine ≥1 SD below the mean value in normal young men; or femoral neck BMD ≥1 SD below the mean in normal young men and ≥1 vertebral deformity or a history of an osteoporotic fracture. Exclusion criteria included secondary causes …