Design of the Fracture Intervention Trial

Abstract

The Fracture Intervention Trial (FIT) is a randomized, double-masked, placebo-controlled trial designed to test the hypothesis that alendronate, an amino-bisphosphonate, will reduce the rate of fractures in women aged 55-80 years with low hip bone marrow density (< 0.68 gm/cm2 at the femoral neck). It is being conducted at 11 clinical centers around the United States with a coordinating center at UC San Francisco. The goal was to randomize 6000 women. When recruitment was completed (in May 1993), 6457 women had been randomized, amounting to 108% of goal. The women were assigned to one of two substudies. The first (Vertebral Deformity study) includes 2023 women who have at least one vertebral deformity, and will test the hypothesis that alendronate reduces the rate of new vertebral deformities during 3 years of follow-up. This substudy has a power of 0.90 to detect a 32% reduction in the incidence of new vertebral deformities, assuming a 6.5% annual incidence of new vertebral deformities in the placebo group. The second study (Clinical Fracture study) includes 4434 women without vertebral deformities at baseline and will test the hypothesis that alendronate reduces the rate of clinically recognized fractures of all types over an average of 4.25 years of follow-up. This substudy has a 0.90 power to detect a 25% reduction in the rate of all clinical fractures, assuming 4% annual incidence in the placebo group. To our knowledge, this is the largest prospective, randomized, controlled study undertaken to determine the effectiveness of a treatment in reducing the risk of fractures in postmenopausal women.