A placebo-controlled trial of primary prevention involving more than 4,000 patients showed no reduction in the risk of fracture after 4 years of treatment with alendronic acid. - GreenMedInfo Summary

(1) Alendronic acid at a dose of 5 mg/day is now licensed in France for primary prevention of postmenopausal fractures. (2) The clinical file is relatively bulky and methodologically adequate, but there are no comparisons with combined hormone replacement therapy or with raloxifen. (3) Three trials have shown that 5 mg/day alendronic acid slows postmenopausal bone loss. However, this effect disappears on treatment cessation, and mineral bone density is only one risk factor for postmenopausal fractures. (4) A placebo-controlled trial of primary prevention involving more than 4,000 patients showed no reduction in the risk of fracture after 4 years of treatment with alendronic acid (5 mg/day for 2 years, then 10 mg/day). (5) Alendronic acid increases the risk of oesophageal ulceration, necessitating strict precautions during ingestion.