The BoDI (Bone Density Investigation) Study

NCT06117124 | Not Yet Recruiting

• 1 other identifier: 325440
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measures taken by two densitometry techniques (quantitative ultrasound and digital x-ray radiogrammetry)

  Level of agreement between the two techniques and correlation of both techniques with clinical findings

  12 months

Secondary Outcomes (1)

• Bone density changes over time

  12 months

Study Arms (2)

Quantitative ultrasound

ACTIVE COMPARATOR

Participants will undergo bone density measurement using two different modalities - quantitative ultrasound and digital x-ray radiogrammetry. Each method will be performed twice over a 12 month period, to assess changes in bone density over time.

Radiation: Digital X-Ray Radiogrammetry; Diagnostic Test: Quantitative Ultrasound (QUS)

Digital x-ray radiogrammetry.

ACTIVE COMPARATOR

Participants will undergo bone density measurement using two different modalities - quantitative ultrasound and digital x-ray radiogrammetry. Each method will be performed twice over a 12 month period, to assess changes in bone density over time.

Radiation: Digital X-Ray Radiogrammetry; Diagnostic Test: Quantitative Ultrasound (QUS)

Interventions

Digital X-Ray Radiogrammetry RADIATION

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.

Digital x-ray radiogrammetry.; Quantitative ultrasound

Quantitative Ultrasound (QUS) DIAGNOSTIC_TEST

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.

Digital x-ray radiogrammetry.; Quantitative ultrasound

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 3-18 years of age (male and female)
• Diagnosis of mild to severe cerebral palsy (Gross Motor Function Classification System Level 1 to 5)

You may not qualify if:

• Progressive or other neurological condition not diagnostic of Cerebral Palsy
• Previous treatment with bisphosphonates or other bone density modifying medications (aside from nutritional supplements)
• Other underlying conditions associated with low bone density e.g. malignancy or inflammatory conditions

Sponsors & Collaborators

• Sussex Community NHS Foundation Trust: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cross-sectional study whose primary objectives are to compare agreement between two bone densitometry techniques in children with cerebral Palsy, and to correlate assessments using both techniques with clinical findings.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 3, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share