Alendronate in the treatment of osteoporosis: a review of the clinical trials.

Osteoporosis is a highly prevalent disease. More than half of postmenopausal women will experience fractures. Women at high risk (osteoporosis as measured by bone density, low trauma fractures of any type, or certain other risk factors) often require pharmacological therapy. However, surveys show that most women who have recently had fractures are currently not being treated. Recent results from the first megatrial of osteoporosis with >6400 participants, the Fracture Intervention Trial (FIT), have provided important advances in our understanding of osteoporosis and the efficacy of alendronate. The FIT study and other large clinical trials show that alendronate effectively increases bone density, reduces the risk of hip and vertebral fractures by approximately half within the first 12-18 months, and, most importantly, reduces the health consequences of fractures. Alendronate is also effective for preventing bone loss in early postmenopausal women. Thus, alendronate represents an important option for preventing and treating this common and debilitating disease. This article summarizes the wealth of data from FIT and other studies of alendronate in the context of the burden of illness associated with osteoporosis.