A double-blind placebo-controlled study of the effects of the bisphosphonate risedronate on bone mass in patients with inflammatory bowel disease.
BACKGROUND
Low bone density and fractures are common in patients with inflammatory bowel disease (IBD).


OBJECTIVE
To determine whether the bisphosphonate risedronate and calcium are safe and effective in preserving bone mass compared to calcium alone in IBD patients with low bone mass.


METHODS
Sixty-one ambulatory patients with Crohn's disease (n = 31) or ulcerative colitis (n = 30) and low bone density.


METHODS
Using a double-blind placebo-controlled trial format, patients were randomized to 12 months of therapy with risedronate 5 mg or placebo. All received a 600 mg calcium supplement. Bone density using dual energy X-ray absorptiometry was performed at baseline and at 12 months. Disease activity, use of corticosteroid, and adverse events were noted.


RESULTS
Forty-eight patients completed the trial. Compared to the placebo group risedronate resulted in a 2.0% (95%CI, 0.02-3.97) and 1.9% (95%CI, 0.21-3.62) improvement in bone density at the spine and hip, respectively. IBD diagnosis, gender, therapy, and disease status had no effect on the results. There were no significant differences in the adverse events.


CONCLUSIONS
Risedronate improved bone density at the spine and hip in patients with either Crohn's disease or ulcerative colitis and low bone mass. These data suggest that risedronate is a safe and effective therapy to improve bone mass in these patients.
Henderson
Sandra
S
Department of Gastroenterology, Sir Charles Gairdner Hospital, Perth, Western Australia.
Hoffman
Neville
N
Prince
Richard
R
D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D005598:Fractures, Spontaneous / Q000517:prevention & control; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000209:etiology / Q000517:prevention & control*; D012016:Reference Values; D000068296:Risedronic Acid; D018570:Risk Assessment; D016896:Treatment Outcome
D000068296:Risedronic Acid; D012968:Etidronic Acid