title: Risedronate improves bone mineral density in Crohn's disease: a two year randomized controlled clinical trial.
abstract: 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.
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Isaac
authors.initials: I
authors.lastname: Soo
authors.forename: Jesse
authors.initials: J
authors.lastname: Siffledeen
authors.forename: Kerry
authors.initials: K
authors.lastname: Siminoski
authors.forename: Bob
authors.initials: B
authors.lastname: McQueen
authors.forename: Richard N
authors.initials: RN
authors.lastname: Fedorak
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology*; D001851:Bone Diseases, Metabolic / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology; D002118:Calcium / Q000097:blood; D002119:Calcium Carbonate / Q000627:therapeutic use; D003424:Crohn Disease / Q000097:blood / Q000150:complications*; D019587:Dietary Supplements; D004311:Double-Blind Method; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D005272:Femur Neck / Q000000981:diagnostic imaging; D006615:Hip / Q000000981:diagnostic imaging; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010024:Osteoporosis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology; D000068296:Risedronic Acid; D013131:Spine / Q000000981:diagnostic imaging; D018709:Statistics, Nonparametric; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D002119:Calcium Carbonate; D000068296:Risedronic Acid; D012968:Etidronic Acid; D002118:Calcium