Two-year efficacy and tolerability of risedronate once a week for the treatment of women with postmenopausal osteoporosis

SUMMARYObjective: The efficacy and tolerability of risedronate once-a-week dosing (35 and 50 mg) were compared with risedronate daily dosing (5 mg) in a 2-year study in women with osteoporosis.Design and methods: This was a randomized, double-blind, active-control study with lumbar spine bone mineral density (BMD) as the primary efficacy endpoint at 1 year. Subjects were women aged 50 years or older, postmenopausal for at least 5 years, and had either a BMD T-score of –2.5 or lower (lumbar spine or total proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. In addition to risedronate treatment, the subjects received 1000 mg daily of elemental calcium supplementation and received vitamin D if the baseline serum 25-hydroxyvitamin D3 level was low.Results: The results after 1 year of treatment were previously published. Of the 1456 women who were randomized and received study medication, 1127 (77%) completed the 2-year study. Over the 2 years of treatment, the incidence of...