Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: Results of the FOSIT study

This randomized, double-masked, placebo-controlled trial evaluated the safe ty, tolerability and effects on bone mineral density (BMD) of alendronate i n a large, multinational population of postmenopausal women with low bone m ass. At 153 centers in 34 countries, 1908 otherwise healthy, postmenopausal women with lumbar spine BMD 2 standard deviations or more below the premen opausal adult mean were randomly assigned to receive oral alendronate 10 mg (n = 950) or placebo (n = 958) once daily for 1 year. All patients receive d 500 mg elemental calcium daily. Baseline characteristics of patients in t he two treatment groups were similar. At 12 months, mean increases in BMD w ere significantly (p less than or equal to 0.001) greater in the alendronat e than the placebo group by 4.9% (95% confidence interval 4.6% to 5.2%) at the lumbar spine, 2.4% (2.0% to 2.8%) at the femoral neck, 3.6% (3.2% to 4. 1%) at the trochanter and 3.0% (2.6% to 3.4%) for the total hip. The incide nce of nonvertebral fractures was significantly lower in the alendronate th an the placebo group (19 vs 37 patients with fractures), representing a 47% risk reduction for nonvertebral fracture for alendronate-treated patients (95% confidence interval 10% to 70%; p = 0.021). Incidences of adverse even ts, including upper gastrointestinal adverse events, were similar in the tw o groups. Therefore, for postmenopausal women with low bone mass, alendrona te is well tolerated and produces significant, progressive increases in BMD at the lumbar spine and hip in addition to significant reduction in the ri sk of nonvertebral fracture.