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Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

This study has been completed.
Information provided by:
University of Alberta Identifier:
First received: October 5, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

The occurrence of bone loss in Crohn's disease patients is an important clinical problem for both patients with and without active disease. While therapy does exist for treatment and prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with adequate calcium and vitamin D supplementation.

The primary objective of the study is to assess the efficacy of risedronate, compared to placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.

Condition Intervention Phase
Crohn's Disease
Low Bone Mineral Density
Drug: risedronate
Drug: placebo
Phase 4

Study Type: Interventional
Official Title: A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Arms Assigned Interventions
Active Comparator: risedronate plus calcium and viamin D Drug: risedronate
Placebo Comparator: placebo plus clacium and vitamin D Drug: placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who are 18 years of age, or older.
  • Crohn's disease, as documented by clinical, radiologic, endoscopic or histologic examination.
  • Osteoporosis (T score less than -2.5) or osteopenia (T score between -1.0 and -2.5), as determined by dual energy X-ray absorptiometry.

Exclusion Criteria:

  • Known bone disorders other than osteoporosis (such as hyperparathyroidism, Paget's disease, renal osteodystrophy and documented osteomalacia)
  • Abnormal thyroid function. Those patients on thyroxine replacement must not have had a change in dose in the two months prior to prospective data collection program entry
  • Clinically significant renal impairment (serum creatinine ≥ 2x normal).
  • Clinical Short Bowel Syndrome
  • Patients on total parenteral or enteral nutrition
  • Spinal anatomy that would not allow adequate assessment of lateral spine using DEXA
  • Patients who had received:

    1. previous bisphosphonate therapy
    2. fluoride supplement in the 24 months prior to entry
    3. calcium supplements of more than 1.0g/day in the 6 months prior to entry
    4. vitamin D supplements greater than 1000 IU/day in the 6 months prior to entry
    5. calcitonin in the 3 months prior to entry
  • Females on hormone replacement therapy who do not agree to continue the therapy for the duration of the prospective data collection program
  • Men on testosterone who do not agree to continue it for the duration of the prospective data collection program
  • Pregnancy or women who are breastfeeding
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Please refer to this study by its identifier: NCT01215890

Canada, Alberta
Gastrointestinal and Liver Disease Research (GILDR) Group
Edmonton, Alberta, Canada, T6G-2X8
Sponsors and Collaborators
University of Alberta
Principal Investigator: Richard Fedorak, MD University of Alberta
  More Information Identifier: NCT01215890     History of Changes
Other Study ID Numbers: RIS-RF
Study First Received: October 5, 2010
Last Updated: October 5, 2010

Keywords provided by University of Alberta:
Crohn's disease
Low bone mineral density
inflammatory bowel disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin D
Risedronate Sodium
Etidronic Acid
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017