Risedronate for the prevention of bone loss after steroid therapy for a flare-up in inflammatory bowel disease

Completed

Conditions: Inflammatory bowel disease (ulcerative colitis and Crohn's disease)
Digestive System
Noninfective inflammatory bowel disease

Registration Number: ISRCTN93280043

Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in percentage change in total hip (and sub-regions of the hip) and lumbar spine bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) 8 weeks apart between treatment groups (baseline is when corticosteroids start and week 8 at completion of the steroids).

Secondary Outcome Measures

Name	Time	Method
1. Do patients with ulcerative colitis and Crohn's disease have a differential response to steroid therapy or risedronate?<br>2. Change in markers of bone turnover (CTX for resorption and P1NP for formation) measured before steroids start (week -1), baseline and at week 8<br>3. Urinary steroid metabolites and cytokines measured from samples obtained at week -1