Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00609752
• Other study ID #: RG_06_266
• Secondary ID: EudraCT: 2006-00
• Status: Recruiting
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: December 29, 2008
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: December 2008
• Source: University Hospital Birmingham
• Contact: M. Stephen Murphy
• Phone: +44 (0)121 333 8705
• Email: m.s.murphy[@]bham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Crohn's Disease is a very serious inflammatory gut disorder that often first presents in childhood. Once present, the underlying condition remains for life. It usually responds well to medical treatment which brings about a disease 'remission' but is inclined to become active again at intervals (relapses). When it is active, children are very unwell with reduced energy, loss of appetite and distressing abdominal symptoms (pain, diarrhea, etc.). Active disease can be treated in two very different ways - either with a 3-month course of steroids (tablets), or with a 6-week course of so called "liquid diet therapy (LDT)." With LDT, children receive all of their nutrition in liquid form. Both treatments have advantages and disadvantages. Both are quite effective, often controlling symptoms within days. Steroids may cause various side effects including thinning of bones (osteoporosis) with increased risk of fractures. LDT is somewhat challenging because normal (solid) foods are not allowed during the period of treatment. Both steroids and LDT are widely used - steroids predominately in the USA and LDT elsewhere. There is controversy as to which is best. This study aims to determine which should be preferred.

In this clinical study, children presenting with Crohn's disease will be randomly assigned to either steroid treatment or LDT and followed up for a period of one year. During that time the assigned treatment will be used for any episodes of active disease. We will study a total of 80 children attending the Paediatric Gastroenterology Units in Birmingham, Bristol, Liverpool, Oxford, Sheffield and St. George's Hospital in London. Various outcomes will be compared in the two groups. We will examine the recovery rates (success in bringing about remission) and the frequency of subsequent relapses. We will compare growth and physical development, because active Crohn's disease and possibly steroids may have adverse effects on these processes. A special focus of the study will be on the effect of the disease and its treatment on bone health. Using special blood and urine tests and bone scans we will compare bone growth and density in the two groups. Finally, it is crucially important that we consider the impact of the disease and its treatment on the young person on the basis of their own individual perspective. To do this we will compare the 'quality of life' of children in the two treatment groups, using a questionnaire specially designed to measure this aspect in young people with Crohn's disease.

This study will thus enable us to undertake a comprehensive comparison of the two major first-line treatments used in childhood Crohn's Disease. This is crucially important, and no such study has previously been undertaken

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Active Crohn's Disease with PCDAI > 20

• Aged 7 - 17 with possibility of 1 year follow-up

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• prednisolone
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.

Dietary Supplement:
• Alicalm (polymeric liquid formula)
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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham	West Midlands
United Kingdom	Bristol Royal Hospital for Sick Children	Bristol
United Kingdom	Royal Liverpool Children's Hospital	Liverpool	Merseyside
United Kingdom	St George's University Hospital	London
United Kingdom	Oxford Children's Hospital	Oxford	Oxfordshire
United Kingdom	Sheffield Children's Hospital	Sheffield	South Yorkshire

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Birmingham	Children's Memorial Research Foundation, SHS International, St George's University Hospital Research Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density change based on DXA measurement at 1 year		12 months post-recruitment	No
Secondary	Proportion in remission		6 weeks	No
Secondary	Change in PCDAI, HAB and pHBS		6 weeks	No
Secondary	Quality of life throughout treatment period, using IMPACT III measurements		12 months	No
Secondary	Baseline urine 11B-HSD1 and bone formation		6 weeks	No
Secondary	Baseline urine 11B-HSD1 activity and change in bone mineral density		12 months	No
Secondary	Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST		12 months	No
Secondary	Growth impairment		12 months	No
Secondary	Adherence to randomised therapy for relapses		12 months	No
Secondary	Adverse effects		12 months	Yes