Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06117124 |
| Other study ID # |
325440 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2025 |
| Est. completion date |
January 2029 |
Study information
| Verified date |
November 2023 |
| Source |
Sussex Community NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
