Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
3 other identifiers
interventional
80
1 country
6
Brief Summary
This study will compare two current first-line treatments for childhood Crohn's Disease, steroids versus a liquid diet, and determine the effects of these treatments on bone health, quality of life and treatment efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 30, 2008
December 1, 2008
1.9 years
January 24, 2008
December 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mineral density change based on DXA measurement at 1 year
12 months post-recruitment
Secondary Outcomes (9)
Proportion in remission
6 weeks
Change in PCDAI, HAB and pHBS
6 weeks
Quality of life throughout treatment period, using IMPACT III measurements
12 months
Baseline urine 11B-HSD1 and bone formation
6 weeks
Baseline urine 11B-HSD1 activity and change in bone mineral density
12 months
- +4 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
Standard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period.
Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a "normal" unrestricted diet by 10 weeks.
Eligibility Criteria
You may qualify if:
- Active Crohn's Disease with PCDAI \> 20
- Aged 7 - 17 with possibility of 1 year follow-up
You may not qualify if:
- Previous treatment for Crohn's Disease with liquid diet or glucocorticoid therapy
- Isolated orofacial granulomatosis
- Intravenous glucocorticoid therapy immediately indicated
- Planned surgical intervention for CD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Birminghamlead
- SHS Internationalcollaborator
- Children's Memorial Research Foundationcollaborator
- St George's University Hospital Research Foundationcollaborator
Study Sites (6)
Bristol Royal Hospital for Sick Children
Bristol, Bristol, BS2 8BJ, United Kingdom
St George's University Hospital
London, London, SW17 0QT, United Kingdom
Royal Liverpool Children's Hospital
Liverpool, Merseyside, L12 2AP, United Kingdom
Oxford Children's Hospital
Oxford, Oxfordshire, OX3 9DZ, United Kingdom
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH, United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
M. Stephen Murphy
University of Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
February 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 30, 2008
Record last verified: 2008-12