Risedronate improves bone mineral density in Crohn's disease: A two year randomized controlled clinical trial

摘要

Background: Patients with Crohn's disease have an increased frequency of osteopenia and osteoporosis. This randomized, controlled, double-blind study assessed the efficacy of risedronate versus placebo in treating low bone mineral density (BMD) in patients with Crohn's disease. Methods: 88 Crohn's disease outpatients with BMD T-score < - 1.0 by dual-energy X-ray absorptiometry were randomly assigned to one of two treatment groups for the two year study duration: one group received risedronate 35. mg weekly while another received placebo. Both groups received daily calcium (Ca; 500. mg) and vitamin D (D; 400. IU) supplementation. Percent change in BMD relative to baseline was compared between the two therapies at 12 and 24. months. Results: Using intent-to-treat analysis, at 12. months, risedronate + Ca + D increased BMD, relative to baseline, more than placebo + Ca + D in the femoral trochanter (1.4 ± 3.4% vs - 0.1 ± 3.1%; p = 0.03) and total hip (1.1 ± 2.7% vs - 0.1 ± 2.5%;p = 0.04). This trend in greater BMD continued for the 24. month duration of the study. There was no difference between the two treatment groups for changes in spine BMD. Subgroup analysis revealed that risedronate + Ca + D resulted in significantly better improvement in femoral trochanter BMD in non-smokers (p = 0.01), males (p = 0.01), those with a history of corticosteroid use in the preceding year (p = 0.01), and current users of immunosuppressants (p = 0.04). Conclusions: Risedronate, in addition to daily calcium and vitamin D supplementation, is superior to calcium and vitamin D alone in improving femoral trochanter and total hip BMD in patients with Crohn's disease.