Placebo-controlled multicenter study of oral alendronate in postmenopausalosteoporotic women

Objectives: To evaluate effects on bone mineral density (BMD), safety, and tolerability of a single daily dose of alendronate (10 mg), administered fo r 1 year to postmenopausal women with osteoporosis. Methods: This interim a nalysis includes the first approximately 20% of patients to complete treatm ent in a large, placebo-controlled study (the Fosamax((TM)1) International Trial (Fosit)), which enrolled 1908 patients from 34 countries. Patients le ss than or equal to 85-years-old with osteoporosis (lumbar spinal BMD great er than or equal to 2 S.D. below mean for mature premenopausal Caucasian wo men) were randomly assigned to treatment with alendronate or placebo once d aily in the morning; all patients received supplemental calcium (500 mg/day ). Dual-Energy X-ray Absorptiometry (DXA) was used to measure BMD in spine and proximal femur. Results: A total of 297 patients had BMD data available for analysis. Patients treated with alendronate showed progressive increas e of BMD during treatment. At 12 months, mean BMD had increased significant ly (P < 0.001) at the lumbar spine (5.6%), trochanter (3.6%), and femoral n eck (2.6%) in the alendronate group. Increases in BMD were significantly (P < 0.001) greater than in the placebo group at all sites. Among 442 patient s assessed for safety, there were no statistically or clinically significan t differences between treatment groups in the incidence of adverse events, including upper gastrointestinal adverse events, or laboratory abnormalitie s. Conclusions: Results of this multinational study show that oral alendron ate, administered as 10 mg once daily for 1 year, is generally well tolerat ed and produces significant, progressive increases in BMD at the lumbar spi ne and proximal femur of postmenopausal women with osteoporosis. (C) 1998 E lsevier Science Ireland Ltd. All rights reserved.