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The BoDI (Bone Density Investigation) Study

NCT06117124 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

RADIATION

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Sussex Community NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2029-01-31
Completion
2029-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117124 on ClinicalTrials.gov