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Risedronate improves bone mineral density in Crohn's disease: a two year randomized controlled clinical trial
Isaac Soo1, Jesse Siffledeen, Kerry Siminoski
1Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
Insights
Risedronate plus calcium and vitamin D improved bone mineral density in Crohn's disease patients more than placebo. This treatment is superior for improving hip and femoral trochanter bone density in these patients.
Area of Science:
- Gastroenterology
- Endocrinology
- Rheumatology
Background:
- Crohn's disease is associated with increased rates of osteopenia and osteoporosis.
- Low bone mineral density (BMD) is a significant concern for patients with Crohn's disease.
Purpose of the Study:
- To evaluate the efficacy of risedronate compared to placebo in treating low BMD in Crohn's disease patients.
- To assess the impact of risedronate on bone mineral density at various skeletal sites.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 88 Crohn's disease outpatients with low BMD (T-score < -1.0).
- Participants received either 35 mg of risedronate weekly or a placebo, alongside daily calcium (500 mg) and vitamin D (400 IU) supplementation for two years.
- Bone mineral density changes were measured using dual-energy X-ray absorptiometry at 12 and 24 months.
Main Results:
- Risedronate significantly increased BMD at the femoral trochanter and total hip compared to placebo after 12 and 24 months.
- No significant difference in spine BMD changes was observed between the risedronate and placebo groups.
- Subgroup analyses indicated greater BMD improvement with risedronate in non-smokers, males, and patients with a history of corticosteroid use or current immunosuppressant use.
Conclusions:
- Risedronate, combined with calcium and vitamin D, demonstrates superiority over calcium and vitamin D alone for enhancing femoral trochanter and total hip BMD in Crohn's disease patients.
- The findings support the use of risedronate as a therapeutic option for managing low bone mineral density in this patient population.
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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