Risedronate improves bone mineral density in Crohn's disease: a two year
randomized controlled clinical trial.
Author(s): Soo I, Siffledeen J, Siminoski K, McQueen B, Fedorak RN.
Affiliation(s): Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
Publication date & source: 2012, J Crohns Colitis. , 6(7):777-86
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.
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