Status:
COMPLETED
Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease
Lead Sponsor:
University of Alberta
Conditions:
Crohn's Disease
Low Bone Mineral Density
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01215890
Last Update
October 7 2010
Active Locations (1)
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1
Gastrointestinal and Liver Disease Research (GILDR) Group
Edmonton, Alberta, Canada, T6G-2X8