A double-blind placebo-controlled study of the effects of the bisphosphonate risedronate on bone mass in patients with inflammatory bowel disease

S. Henderson, N. Hoffman, Richard Prince

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    57 Citations (Scopus)

    Abstract

    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.PATIENTS: 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.
    Original languageEnglish
    Pages (from-to)119-123
    JournalAmerican Journal of Gastroenterology
    Volume101
    Issue number1
    DOIs
    Publication statusPublished - 2006

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    Diphosphonates
    Inflammatory Bowel Diseases
    Placebos
    Bone Density
    Bone and Bones
    Calcium
    Ulcerative Colitis
    Crohn Disease
    Hip
    Spine
    Bone Fractures
    Photon Absorptiometry
    Risedronate Sodium
    Adrenal Cortex Hormones
    Therapeutics

    Cite this

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    title = "A double-blind placebo-controlled study of the effects of the bisphosphonate risedronate on bone mass in patients with inflammatory bowel disease",
    abstract = "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.PATIENTS: 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.",
    author = "S. Henderson and N. Hoffman and Richard Prince",
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    doi = "10.1111/j.1572-0241.2006.00372.x",
    language = "English",
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    T1 - A double-blind placebo-controlled study of the effects of the bisphosphonate risedronate on bone mass in patients with inflammatory bowel disease

    AU - Henderson, S.

    AU - Hoffman, N.

    AU - Prince, Richard

    PY - 2006

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    N2 - 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.PATIENTS: 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.

    AB - 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.PATIENTS: 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.

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