Background Five hundred and nine patients, receiving moderate to high doses of oral corticosteroids (equivalent to 7.5 mg prednisone daily or greater), were enrolled in two studies to examine the effect of risedronate.
Objectives We report here on the results of the group of postmenopausal women in these studies (n = 255).
Methods Patients in these studies were randomised to receive placebo, or risedronate (RIS) 2.5 mg, or RIS 5 mg for 1 year. Patients were supplemented with daily elemental calcium (500–1000 mg) and the majority also received supplemental vitamin D (400 IU). Spinal BMD was measured every 3 months; spinal radiographs were taken at baseline and 1 year.
Results In this group of postmenopausal women, RIS 5 mg significantly increased spinal BMD by 2.6% vs placebo (p less than 0.01). Nine out of 56 placebo patients had a new vertebral fracture compared with 3 out of 62 in the RIS 5 mg treated group. This vertebral fracture risk reduction was 73% (p = 0.050). Effects of 2.5 mg were consistent with these results.
Conclusion In summary, this study demonstrates that risedronate is effective in maintaining or increasing bone mass and reducing the risk of new vertebral fractures in postmenopausal women on corticosteroid therapy. These findings are consistent with risedronate effects observed in large, 3 year studies in women with confirmed postmenopausal osteoporosis.
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