Efficacy and Safety of Daily Risedronate in the Treatment of Corticosteroid-Induced Osteoporosis in Men and Women: A Randomized Trial

Oxford University Press (OUP) - Tập 15 Số 6 - Trang 1006-1013 - 2000
David B. Dunger1, Rodney Hughes2, Roland Laan3, N. Sacco-Gibson4, D Wenderoth5, Silvano Adami6, Rachelle Eusebio4, Jean‐Pierre Devogelaer7
1Department of Medicine and Therapeutics, University of Aberdeen, Medical School Buildings, Foresterhill, Aberdeen, United Kingdom
2St. Peter's Hospital, Chertsey, United Kingdom
3Academisch Ziekenhuis, Nijmegen, The Netherlands
4Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, U.S.A.
5Procter & Gamble Pharmaceuticals, Staines, United Kingdom.
6Centro Osteoporosi, Verona, Italy
7Department of Rheumatology, Louvain University in Brussels, Cliniques Universitaire Saint-Luc, Brussels, Belgium

Tóm tắt

Abstract Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone ≥ 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12. Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures. Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010). Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group. Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042). Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients with corticosteroid-induced osteoporosis.

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Oxford University Press (OUP)

Tập 15 Số 6

1006-1013

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