Cerebral PalsyNCT06117124
The BoDI (Bone Density Investigation) Study
A study testing Digital X-Ray Radiogrammetry and Quantitative Ultrasound (QUS) in people with Cerebral Palsy, run by Sussex Community NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Digital X-Ray Radiogrammetry and Quantitative Ultrasound (QUS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
Background:
This study involves children with cerebral palsy, a lifelong condition caused by early damage to the developing brain.
Read more
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.
Read the detailed description
Osteoporosis is a condition in which bone strength and structure is altered, so that it is more likely to break or fracture. It is a condition that has been traditionally associated with age, with women of a post-menopausal age particularly at risk. However, poor bone strength (or medically termed 'bone density') is increasingly recognised in children suffering from chronic health conditions. It is usually caused by a combination of the disease process itself, as well as the treatments and consequences of the disease.
Where childhood is usually the critical period in which bone strength is developed (and 'bone mass' accrued), these at-risk children enter adulthood with much weaker bones and at much higher ongoing risk of fracture. To minimise this risk in adulthood, the core difficulty with bone strength in childhood needs to be addressed. Of all childhood chronic health conditions, cerebral palsy is the most common condition associated with low bone density. It affects 2.7 in 1000 births and is increasing in incidence due to the increased survival of low-birth-weight infants. Low bone density is universal in children with moderate to severe Cerebral Palsy after the age of 10 years, and up to a quarter of these children will present with low-impact fractures. These are associated with pain, loss of function and quality of life, as well as significant complications, and they currently represent the most common medical problem seen in children with cerebral palsy attending residential schools.
There is currently no clear guidance for this population of at-risk children with regards to the appropriate method or timing of bone density screening. In addition, while Dual energy x-ray absorptiometry (DEXA) is currently the recommended method for measurement of bone density in children and adolescents, it has a number of limitations specifically in children with cerebral palsy. These include difficulties with accessing appropriate scanners, challenges regarding positioning and movement during scanning, and other challenges such as metallic implants from spinal and hip surgeries impacting on the ability to achieve accurate results. There is an increasing interest therefore in alternative methods of measuring bone strength in children. In 2021, a systematic review paper analysed 22 studies comparing alternative methods to DEXA in children; it concluded that quantitative ultrasound and digital x-ray radiogrammetry were both reliable methods that warrant further investigation. Of note, none of the included studies focused on children with cerebral palsy.
This study would be the first to investigate the use of these two alternative methods in children with cerebral palsy. It will address the important question of whether there is a role for these potentially more acceptable methods in screening for low bone density and predicting future fracture risk. It will also align with the research priority set by the James Lind Alliance in 2022 of managing 'distressing symptoms such as pain' in children with neurological conditions.
The aim of this study is to compare quantitative ultrasound and digital x-ray radiogrammetry as alternative and more suitable methods of bone densitometry in children with cerebral palsy.
The primary objectives of the study are:
- To compare agreement between the two densitometry techniques in children with Cerebral Palsy
- To investigate the correlation between assessments using both techniques and clinical information/ risk factors for low bone density in children with Cerebral Palsy
The secondary objectives of the study are:
- To compare bone density changes over time and identify the most appropriate timing and site of bone density screening in children with Cerebral Palsy
- To establish the risk factors associated with low bone density and pathological (low impact) fracture in this at-risk group of children
- To compare intra- and interobserver variability for both methods: that is, how consistent the results are when the investigation is performed on the same patient by the same practitioner, and on the same patient by a different practitioner.
- To compare the practicality of both methods (from the participant and practitioner viewpoint) and the cost-effectiveness of both methods
- To devise a large multi-centre trial comparing the superior of the two methods to DEXA scanning.
- Conditions
- Cerebral Palsy
- Being tested
- Digital X-Ray Radiogrammetry, Quantitative Ultrasound (QUS)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital X-Ray RadiogrammetryRadiation
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Digital X-Ray Radiogrammetry; Diagnostic Test: Quantitative Ultrasound (QUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Bone density changes over time
- assess bone density changes over time and identify the most appropriate timing and site of bone density screening
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study startAug 2025 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sussex Community NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117124
- Sponsor's protocol ID
- 325440
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06117124
- Acronym / sponsor ID
- 325440
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sussex Community NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoporosis is a condition in which bone strength and structure is altered, so that it is more likely to break or fracture. It is a condition that has been traditionally associated with age, with women of a post-menopausal age particularly at risk. However, poor bone strength (or medically termed 'bone density') is increasingly recognised in children suffering from chronic health conditions. It is usually caused by a combination of the disease process itself, as well as the treatments and consequences of the disease.
Where childhood is usually the critical period in which bone strength is developed (and 'bone mass' accrued), these at-risk children enter adulthood with much weaker bones and at much higher ongoing risk of fracture. To minimise this risk in adulthood, the core difficulty with bone strength in childhood needs to be addressed. Of all childhood chronic health conditions, cerebral palsy is the most common condition associated with low bone density. It affects 2.7 in 1000 births and is increasing in incidence due to the increased survival of low-birth-weight infants. Low bone density is universal in children with moderate to severe Cerebral Palsy after the age of 10 years, and up to a quarter of these children will present with low-impact fractures. These are associated with pain, loss of function and quality of life, as well as significant complications, and they currently represent the most common medical problem seen in children with cerebral palsy attending residential schools.
There is currently no clear guidance for this population of at-risk children with regards to the appropriate method or timing of bone density screening. In addition, while Dual energy x-ray absorptiometry (DEXA) is currently the recommended method for measurement of bone density in children and adolescents, it has a number of limitations specifically in children with cerebral palsy. These include difficulties with accessing appropriate scanners, challenges regarding positioning and movement during scanning, and other challenges such as metallic implants from spinal and hip surgeries impacting on the ability to achieve accurate results. There is an increasing interest therefore in alternative methods of measuring bone strength in children. In 2021, a systematic review paper analysed 22 studies comparing alternative methods to DEXA in children; it concluded that quantitative ultrasound and digital x-ray radiogrammetry were both reliable methods that warrant further investigation. Of note, none of the included studies focused on children with cerebral palsy.
This study would be the first to investigate the use of these two alternative methods in children with cerebral palsy. It will address the important question of whether there is a role for these potentially more acceptable methods in screening for low bone density and predicting future fracture risk. It will also align with the research priority set by the James Lind Alliance in 2022 of managing 'distressing symptoms such as pain' in children with neurological conditions.
The aim of this study is to compare quantitative ultrasound and digital x-ray radiogrammetry as alternative and more suitable methods of bone densitometry in children with cerebral palsy.
The primary objectives of the study are:
- To compare agreement between the two densitometry techniques in children with Cerebral Palsy
- To investigate the correlation between assessments using both techniques and clinical information/ risk factors for low bone density in children with Cerebral Palsy
The secondary objectives of the study are:
- To compare bone density changes over time and identify the most appropriate timing and site of bone density screening in children with Cerebral Palsy
- To establish the risk factors associated with low bone density and pathological (low impact) fracture in this at-risk group of children
- To compare intra- and interobserver variability for both methods: that is, how consistent the results are when the investigation is performed on the same patient by the same practitioner, and on the same patient by a different practitioner.
- To compare the practicality of both methods (from the participant and practitioner viewpoint) and the cost-effectiveness of both methods
- To devise a large multi-centre trial comparing the superior of the two methods to DEXA scanning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quantitative ultrasound | Active comparator | Radiation: Digital X-Ray Radiogrammetry, Diagnostic Test: Quantitative Ultrasound (QUS)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. |
| Digital x-ray radiogrammetry. | Active comparator | Radiation: Digital X-Ray Radiogrammetry, Diagnostic Test: Quantitative Ultrasound (QUS)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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital X-Ray RadiogrammetryAn 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. | Radiation | Digital x-ray radiogrammetry., Quantitative ultrasound |
| 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. | Diagnostic test | Digital x-ray radiogrammetry., Quantitative ultrasound |
Primary outcome
Measures taken by two densitometry techniques (quantitative ultrasound and digital x-ray radiogrammetry)
Time frame: 12 months
Level of agreement between the two techniques and correlation of both techniques with clinical findings
1 secondary outcome
Bone density changes over time
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital X-Ray Radiogrammetry and Quantitative Ultrasound (QUS) in people with Cerebral Palsy, run by Sussex Community NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures taken by two densitometry techniques (quantitative ultrasound and digital x-ray radiogrammetry) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.