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The BoDI (Bone Density Investigation) Study
Sponsor: Sussex Community NHS Foundation Trust
Summary
Background: This study involves children with cerebral palsy, a lifelong condition caused by early damage to the developing brain. This condition is associated with impairments in mobility and motor control, eating and drinking, communication and learning, as well as other physical health difficulties. Included in these is a risk of developing osteoporosis, that is thin, weakened bones which are more prone to fracture. Currently there is no clear guidance for how bone density should be measured or monitored in this vulnerable group of children. The recommended imaging method in children, dual energy x-ray absorptiometry (DEXA) has specific and significant limitations in children with cerebral palsy. Aim: This study aims to investigate two alternative methods of measuring bone density, quantitative ultrasound and digital x-ray radiogrammetry. The former uses ultrasound to measure the strength and elasticity of bone, while the latter uses hand x-rays to calculate bone density. It aims to explore the reliability, acceptability and clinical utility of both methods, as well as the correlation between the two methods. Risk factors and the clinical course of the disease will also be explored. Method: The study aims to recruit 70 children and young people aged 3-18 years with cerebral palsy. Participants will undergo both methods of bone density measurement twice over a 12-month period. Information on clinical risk factors and fracture rate will be taken from clinical records.
Official title: The BoDI (Bone Density Investigation) Study: Comparing Quantitative Ultrasound and Digital X-Ray Radiogrammetry in the Investigation of Bone Density in Children with Cerebral Palsy
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-08
Completion Date
2029-01
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
Digital X-Ray Radiogrammetry
An x-ray of the left hand will be taken by a Radiographer. This will be uploaded to PACS and analysed using BoneXpert software. This calculates bone density as a 'Bone Health Index', and provides a standard deviation score for age, gender and bone age.
Quantitative Ultrasound (QUS)
The MiniOmni Bone Densitometer will be used to measure bone density at three peripheral sites on both sides of the body (left and right): the distal radius (lower arm), mid-tibia (lower leg) and phalynx (hand). The speed of ultrasound (speed of sound) through the bone will be measured and converted to a standard deviation score.