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

NCT01215890 | Completed Phase 4

• 1 other identifier: RIS-RF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn's Disease; Low Bone Mineral Density

Keywords

Crohn's disease; Low bone mineral density; inflammatory bowel disease; bisphosphonate

Study Arms (2)

risedronate plus calcium and viamin D

ACTIVE COMPARATOR

Drug: risedronate

placebo plus clacium and vitamin D

PLACEBO COMPARATOR

Drug: placebo

Interventions

risedronate DRUG

risedronate plus calcium and viamin D

placebo DRUG

placebo plus clacium and vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• previous bisphosphonate therapy
• fluoride supplement in the 24 months prior to entry
• calcium supplements of more than 1.0g/day in the 6 months prior to entry
• vitamin D supplements greater than 1000 IU/day in the 6 months prior to entry
• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Gastrointestinal and Liver Disease Research (GILDR) Group

Edmonton, Alberta, T6G-2X8, Canada

Location

MeSH Terms

Conditions

Crohn Disease; Bone Diseases, Metabolic; Inflammatory Bowel Diseases

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Fedorak, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

CA (1)