Alendronate sodium in the management of osteoporosis.

ABSTRACT

Alendronate is one of the best and most extensively studied bisphosphonates in the treatment of osteoporosis. This review considers in detail the major pivotal study, the fracture intervention trial (FIT), upon which the use of alendronate is based and which was a landmark study in terms of design, size and clinical impact. The role of alendronate has subsequently been underscored by a range of studies extending the clinical indications for its use and consolidating the effect on reducing both vertebral and non-vertebral fracture risk. Although the emphasis of these studies has predominantly been on the management of postmenopausal osteoporosis, data is also available in primary prevention, men, and glucocorticoids-induced osteoporosis. Direct comparison between the different drugs used to treat osteoporosis with fracture end points are needed for patients and doctors to make informed choices, but the size of such studies are prohibitive. Clinical trials using surrogate markers such as bone mineral density and biochemical markers of bone turnover have been performed which provide some helpful information but the limitations of this approach need to be recognized.