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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. - Residronate prevening bone loss in IBD during short course steroids.

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. - Residronate prevening bone loss in IBD during short course steroids.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004325-10-GB
Enrollment
120
Registered
2005-06-13
Start date
2005-08-16
Completion date
Unknown
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We aim to determine whether Risedronate is effective at preventing acute bone loss associated with a short course of corticosteroid (CS) therapy to treat exacerbations of inflammatory bowel disease (IBD).

Interventions

Trade Name: Actonel Once a Week 35mg Pharmaceutical Form: Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: CACIT D3 effervescent granules, 50

Sponsors

United Bristol Healthcare Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with ulcerative colitis or Crohn’s disease experiencing a flare up and requiring steroid therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Evidence of osteoporosis (known vertebral fracture, T score<-2.5). •Pregnant and lactating women. Women of child-bearing age will be eligible provided by use reliable contraception. •Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D), previous treatment with bisphosphonate at any time. •Associated disorder which may influence bone metabolism.

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary outcome of this study will be a difference in percentage change in total hip BMD over the first two months of the study between treatment groups. ;Secondary Objective: Sub-group analysis will be performed to determine whether patients with Crohn's disease and Ulcerative colitis show a differential response to steroid therapy or Risedronate. Secondary objectives will also be the change in the markers of bone turnover - PINP, collagen crosslinks, alkaline phosphatase and osteocalcin ;Primary end point(s): Whether bisphosphonate prevents bone loss when administered in this way will be assessed by comparing change in BMD over the course of the study between treatment groups.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026