[Clinical trials of alendronate]

A number of large scale double-blind controlled studies with alendronate were carried out to evaluate therapeutic efficacy for osteoporotics. Alendronate administered orally at 5 mg per day for 7 years induced an average 8.2% increase of bone mineral density in the spine and 2.6% in the hip. Alendronate given orally for 4 years decreased significantly by 44% the occurrence of vertebral and non-vertebral fractures in patients with low bone mineral density and at least one fracture. In patients without any fracture, the results were significant for non-vertebral fractures when initial BMD was low. In histomorphometry with iliac bone biopsies, mineralization was normal, and trabecular bone turnover markedly decreased in patients receiving long-term dosing with alendronate. Alendronate is expected to have a potency to inhibit bone fracture occurrence in Japanese osteoporotics safely.