The BoDI (Bone Density Investigation) Study

Sponsor
Sussex Community NHS Foundation Trust
Study ID
NCT06117124
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Nov 3, 2023
Start date
Aug 31, 2025
Status verified
Mar 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Quantitative ultrasound
    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.
  • Active Comparator: Digital x-ray radiogrammetry.
    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.

Primary Outcome Measure

Measures taken by two densitometry techniques (quantitative ultrasound and digital x-ray radiogrammetry) [ Time Frame: 12 months ]

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