ORAL ALENDRONATE INDUCES PROGRESSIVE INCREASES IN BONE MASS OF THE SPINE, HIP, AND TOTAL-BODY OVER 3 YEARS IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS

To determine the effects of long-term daily oral alendronate sodium (A LN) on bone mass in postmenopausal women with osteoporosis, 19 centers enrolled 516 postmenopausal women aged 45-80 gears with spine bone mi neral density (BMD) at least 2.5 SD below the mean for young premenopa usal women in a 3-year, double-blind, placebo-controlled study, Subjec ts were randomly allocated to one of four treatment groups: placebo; a lendronate, 5 or 10 mg/day for 3 years; or alendronate, 20 mg/day for 2 years followed by 5 mg/day for the 3rd year, All patients received 5 00 mg/day of supplemental calcium to ensure adequate calcium intake. B MD was measured by dual-energy X-ray absorptiometry at several skeleta l sites, Nonsignificant mean decreases in BMD of the spine, femoral ne ck, and trochanter of 0.6, 0.7, and 0.4%, respectively, occurred in th e placebo group at 3 gears, Relative to placebo-treated patients, spin e BMD increased by 5.4%, 7.4%, and 8.4% in the 5, 10, and 20/5 mg ALN groups, respectively, Increases at the femoral neck were 3.5%, 5.5%, a nd 4.3%, and those at the trochanter were 5.1%, 7.2%, and 7.2%, respec tively, Thus, efficacy of 10 and 20/5 mg ALN was similar, whereas the 5 mg dose was less effective, BMD continued to increase over the entir e 3-year study duration in the ALN-treated groups and, compared with t he other dosage groups, 10 mg ALN produced the largest gains in BMD du ring the 3rd year, Changes in biochemical markers of bone turnover and mineral homeostasis confirmed the effect of ALN to decrease bone turn over to a new steady-state level, The safety and tolerability of ALN w ere comparable with those of placebo, In summary, 10 mg daily oral ALN given for 3 years significantly and progressively increases bone mass and is a generally well-tolerated treatment for osteoporosis in postm enopausal women.