ISRCTN93280043
Completed
Not Applicable
A randomised controlled trial to evaluate whether a short course of once weekly risedronate prevents bone loss following high-dose steroid therapy for an acute exacerbation of inflammatory bowel disease
niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites100 target enrollmentNovember 20, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory bowel disease (ulcerative colitis and Crohn's disease)
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged greater than or equal to 16 years, either sex
- •2\. Ulcerative colitis and Crohn's disease
- •3\. Experiencing a relapse
- •4\. Requiring steroid therapy
Exclusion Criteria
- •1\. Aged under 16 years
- •2\. Use of corticosteroids in the preceding 3 months
- •3\. Evidence of osteoporosis (known vertebral fracture, T score less than \-2\.5\)
- •4\. Pregnant and lactating women
- •5\. Women of childbearing age will be eligible provided they use reliable contraception
- •6\. Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D)
- •7\. Previous treatment with a bisphosphonate at any time
- •8\. Associated disorder which may influence bone metabolism
- •9\. Lactose intolerance
Outcomes
Primary Outcomes
Not specified
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