Bone Metabolism, Strength and Mineral Density in Childhood IBD. V1.0
Research type
Research Study
Full title
Bone Metabolism, Bone Mineral Density and Bone Strength in Childhood IBD - Impact of Biological and Conventional Immunomodulator Therapy.
IRAS ID
65290
Contact name
M. Stephen Murphy
Contact email
Sponsor organisation
Birmingham Children's Hospital NHS Foundation Trust
Research summary
Approximately 25% of patients with inflammatory bowel disease (IBD) first present before 18 years of age. Each year about 700 new cases of paediatric IBD occur in the UK, and about 50% of these are less than 11 years old. IBD is associated with serious morbidity. Patients with active IBD experience symptoms such as abdominal pain, bloody diarrhoea, anorexia, weight loss and profound lethargy. In addition, there are potential long-term complications, especially in those who experience poor disease control. Impaired growth is common. With regard to this proposal, IBD often has adverse effects on skeletal development and mineralisation and may lead to osteoporosis and fractures. Azathioprine has been used in IBD for many years and has a beneficial effect in many but not all cases. In recent years an anti-TNFα monoclonal antibody known as infliximab, has increasingly been used with effect, and may beneficially affect bone metabolism and bone mineralisation. It is crucially important that we examine these two maintenance therapies to further understand their proper roles in the management of paediatric IBD. This prospective cohort study will examine bone metabolism and the structure and function of the musculoskeletal unit in children and young people being treated with azathioprine or infliximab. An important additional benefit is that it will allow us to examine the value of pQCT and the technique of mechanography in these patients, both of which have great potential for the study of bone development in children undergoing treatment for a range of inflammatory disorders in addition to IBD
IBD is associated with reduced bone mineral density, osteoporosis and fractures. Our aim is to undertake a prospective clinical study within the NIHR/Wellcome Trust Clinical Research Facility at Birmingham Children’s Hospital Foundation Trust.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
13/WM/0085
Date of REC Opinion
17 Jun 2013
REC opinion
Further Information Favourable Opinion