Clinical trial NCT00609752: Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Official title: Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn Disease
Keywords: Crohn Disease
Children
Bone Density
Prednisolone
Liquid Diet Therapy
Quality of Life
Metabolic Bone Disease
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: SHS International
name: Children's Memorial Research Foundation
name: St George's University Hospital Research Foundation
First posted: 2008-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density change based on DXA measurement at 1 year
timeFrame: 12 months post-recruitment
Secondary outcomes:
measure: Proportion in remission
timeFrame: 6 weeks
measure: Change in PCDAI, HAB and pHBS
timeFrame: 6 weeks
measure: Quality of life throughout treatment period, using IMPACT III measurements
timeFrame: 12 months
measure: Baseline urine 11B-HSD1 and bone formation
timeFrame: 6 weeks
measure: Baseline urine 11B-HSD1 activity and change in bone mineral density
timeFrame: 12 months
measure: Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST
timeFrame: 12 months
measure: Growth impairment
timeFrame: 12 months
measure: Adherence to randomised therapy for relapses
timeFrame: 12 months
measure: Adverse effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital
state: Merseyside
city: Oxford
country: United Kingdom
facility: Oxford Children's Hospital
state: Oxfordshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: West Midlands
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: St George's University Hospital
Study officials:
affiliation: University of Birmingham
name: M. Stephen Murphy
role: STUDY_DIRECTOR
References: