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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
SHS International
Children's Memorial Research Foundation
St George's University Hospital Research Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00609752
First received: January 24, 2008
Last updated: December 29, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Crohn Disease
Drug: prednisolone
Dietary Supplement: Alicalm (polymeric liquid formula)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • Bone mineral density change based on DXA measurement at 1 year [ Time Frame: 12 months post-recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion in remission [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change in PCDAI, HAB and pHBS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Quality of life throughout treatment period, using IMPACT III measurements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Baseline urine 11B-HSD1 and bone formation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Baseline urine 11B-HSD1 activity and change in bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Growth impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adherence to randomised therapy for relapses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Active Comparator: 2 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.
Other Name: Alicalm (SHS International Ltd.)

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

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609752

Contacts
Contact: M. Stephen Murphy +44 (0)121 333 8705 m.s.murphy@bham.ac.uk
Contact: Kelly Spencer +44 (0)121 333 9542 k.spencer@bham.ac.uk

Locations
United Kingdom
Royal Liverpool Children's Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Principal Investigator: Mark Dalzell         
Oxford Children's Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DZ
Principal Investigator: Astor Rodrigues         
Sheffield Children's Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Principal Investigator: Christopher Taylor         
Birmingham Children's Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Contact: Kelly Spencer    +44 (0)121 333 9542    k.spencer@bham.ac.uk   
Principal Investigator: M Stephen Murphy         
Bristol Royal Hospital for Sick Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Principal Investigator: Christine Spray         
St George's University Hospital Recruiting
London, United Kingdom, SW17 0QT
Principal Investigator: Sally Mitton         
Sponsors and Collaborators
University Hospital Birmingham
SHS International
Children's Memorial Research Foundation
St George's University Hospital Research Foundation
Investigators
Study Director: M. Stephen Murphy University of Birmingham
  More Information

No publications provided

Responsible Party: Dr M S Murphy, University of Birmingham
ClinicalTrials.gov Identifier: NCT00609752     History of Changes
Other Study ID Numbers: RG_06_266, EudraCT: 2006-000209-48, CTA: 21761/0213/001
Study First Received: January 24, 2008
Last Updated: December 29, 2008
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Birmingham:
Crohn Disease
Children
Bone Density
Prednisolone
Liquid Diet Therapy
Quality of Life
Metabolic Bone Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Glucocorticoids
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 28, 2014