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

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01215890
First received: October 5, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215890

Locations
Canada, Alberta
Gastrointestinal and Liver Disease Research (GILDR) Group
Edmonton, Alberta, Canada, T6G-2X8
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Richard Fedorak, MD University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01215890     History of Changes
Other Study ID Numbers: RIS-RF
Study First Received: October 5, 2010
Last Updated: October 5, 2010
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin D
Vitamins
Risedronic acid
Etidronic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014