Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000135718p
Ethics application status
Not yet submitted
Date submitted
3/12/2021
Date registered
27/01/2022
Date last updated
27/01/2022
Date data sharing statement initially provided
27/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of spinal cord disorders on bone health in children
Scientific title
A study of bone characteristics in paediatric spinal cord disorders
Secondary ID [1] 305968 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Disorder 324566 0
Bone development 324569 0
Condition category
Condition code
Neurological 322036 322036 0 0
Other neurological disorders
Musculoskeletal 322295 322295 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Paediatric spinal cord injury results in a myriad of health issues. We wish to observe the effects of bone health and development/deterioration following diagnosis with a spinal cord disorder. This will be achieved using bone imaging and blood tests for bone health markers. The cohort will be observed over a two year period, at 6 monthly intervals throughout this period.
The bone imaging component will involve two separate scans - peripheral quantitative computed tomography (pQCT) scan performed at each 6 monthly interval, and a dual energy X-ray absorptiometry (DXA) scan performed once yearly, at every second 6th monthly interval. Both scan types have an anticipated duration of 30 minutes. The pQCT scans the children's forearm and ankle whilst seated, and the DXA scans the spine, hip, forearm and thigh whilst lying prone. The scans will be conducted by a paediatric endocrinologist.
The blood draws will be conducted by a nurse and performed at 6th monthly intervals for the first year, then at the 12th monthly interval for the second year. The blood draws are anticipated to take 5 minutes.
Participants will also be asked to complete questionnaires/other assessments at each 6 monthly interval study visit, as outlined below:
- Age-appropriate tools assessing pain, each anticipated to take 5 minutes to complete, include the FLACC scale, FPS-R and Verbal Numeric Rating Scale, as well as the International Spinal Cord Injury Pain Classification (approx. 10 minutes).
- The Pediatric Spinal Cord Injury Activity Measures Short Forms and WISCI-II will be used to assess activity levels, each anticipated to take 10 minutes to complete.
- The PMoP short form will be used to assess daily living activities, and is also anticipated to take 10 minutes to complete.
The total anticipated duration of the study visit is approximately 3-4 hours, including wait times.
Intervention code [1] 322359 0
Diagnosis / Prognosis
Comparator / control treatment
There will be no recruitment of control group. This is a longitudinal study that will examine the development of bone within each participant.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329794 0
Volumetric Bone Mineral Density (vBMD) at the tibial 4% site (ankle) (measured by peripheral quantitative computed tomography (pQCT))
Timepoint [1] 329794 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Primary outcome [2] 329795 0
Bone geometry at the tibial 4% site (ankle) (measured by peripheral quantitative computed tomography (pQCT))
Timepoint [2] 329795 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Primary outcome [3] 330062 0
Bone mineral content (measured by dual x-ray absorptiometry (DXA)
Timepoint [3] 330062 0
At enrolment, and at 12 and 24 months post-enrolment
Secondary outcome [1] 403807 0
PRIMARY OUTCOME: Bone mineral density (measured by dual x-ray absorptiometry (DXA)
Timepoint [1] 403807 0
At enrolment, and at 12 and 24 months post-enrolment
Secondary outcome [2] 403808 0
pQCT: vBMD of the tibial 66% site (shin)
Timepoint [2] 403808 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [3] 403809 0
pQCT: bone cross sectional area of tibia
Timepoint [3] 403809 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [4] 403810 0
pQCT: bone cross sectional area of radius
Timepoint [4] 403810 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [5] 403811 0
pQCT: muscle cross sectional area of gastrocnemius
Timepoint [5] 403811 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [6] 403812 0
pQCT: bone mineral content of tibia
Timepoint [6] 403812 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [7] 403813 0
pQCT: bone mineral content of radius
Timepoint [7] 403813 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [8] 404770 0
pQCT: Bending strength of radius
Timepoint [8] 404770 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [9] 404771 0
pQCT: Bending strength of tibia
Timepoint [9] 404771 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [10] 404772 0
Blood Calcium levels
Timepoint [10] 404772 0
At enrolment, at 6, 12 and 24 months post-enrolment
Secondary outcome [11] 404773 0
Blood Phosphate levels
Timepoint [11] 404773 0
At enrolment, at 6, 12 and 24 months post-enrolment
Secondary outcome [12] 404774 0
Blood Vitamin D levels
Timepoint [12] 404774 0
At enrolment, at 6, 12 and 24 months post-enrolment
Secondary outcome [13] 404775 0
Blood Alkaline phosphatase levels
Timepoint [13] 404775 0
At enrolment, at 6, 12 and 24 months post-enrolment
Secondary outcome [14] 404776 0
Pain assessment tool for children aged 0-3: FLACC Scale
Timepoint [14] 404776 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [15] 404777 0
Pain assessment tool for children aged 3-12: FPS-R
Timepoint [15] 404777 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [16] 404778 0
Pain assessment tool for children aged 12-18: Verbal Numeric Rating Scale
Timepoint [16] 404778 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [17] 404779 0
Pain assessment tool for all children: International Spinal Cord Injury Pain Classification
Timepoint [17] 404779 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [18] 404780 0
Activity assessment tool for all children: Pediatric Spinal Cord Injury Activity Measures Short Form
Timepoint [18] 404780 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [19] 404781 0
Activity assessment tool for all children: Walking Index for Spinal Cord Injury II
Timepoint [19] 404781 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment
Secondary outcome [20] 404782 0
Participation assessment tool for all children: Pediatric Measure of Participation Short Form
Timepoint [20] 404782 0
At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Eligibility
Key inclusion criteria
Is between the ages of 0 and 16 at time of SCD diagnosis. If potential participant was diagnosed during this time period, but is still under the age of 18, they may participate in the cross-sectional part of this study.
Spinal cord injury diagnosis classified according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) and American Spinal Cord Injury Association Impairment Scale (AIS) levels A to D
Diagnostic ICD codes:
- Relating to traumatic SCD: S12, S17, S22, T06, T08, T09, and T14.9, including all subcodes.
- Relating to non-traumatic SCD: B99, G04, G37, G95 I171.4, L02.9, and M8000/1.
- Non-specific lesion codes for acute paraplegia: G8201, G8203, G8205, G8211, G8213, G8215, G8221, G8223, G8225
- Non-specific lesion codes for acute tetraplegia: G8231, 8235, G8241, G8243, G8245, G8251, G8253, G8255
- Cauda equina syndrome: G8234
Provide a signed and dated informed assent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Premorbid neuromuscular condition
Known primary bone disorder
Prior diagnosis of a neural tube defect i.e., spina bifida
Is unable to attend for assessments
Inability or unwillingness of participant or legally acceptable representative to give written informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Paediatric SCD is a rare condition. Given the sample size is expected to be small for this study, we may not be able to conduct formal statistical analyses. Therefore we will analyse the data descriptively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21271 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 36141 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 310309 0
Hospital
Name [1] 310309 0
The Royal Children's Hospital
Country [1] 310309 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute
Address
50 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 311430 0
None
Name [1] 311430 0
Address [1] 311430 0
Country [1] 311430 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309973 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 309973 0
50 Flemington Rd, Parkville VIC 3052
Ethics committee country [1] 309973 0
Australia
Date submitted for ethics approval [1] 309973 0
28/01/2022
Approval date [1] 309973 0
Ethics approval number [1] 309973 0

Summary
Brief summary
Paediatric spinal cord disorder (SCD) is a devastating occurrence that carries severe physiological consequences. Because children are still developing, the effects of injury differ significantly from those seen in adults with SCD. Among these are the effects on bone health in children with SCD. The loss of neural input and compromised musculoskeletal interaction causes the disruption of bone growth below the injury site. This poses significant implications for later life. Despite the significant negative effect of SCD on bone health in children, there is a lack of evidence based clinical practice guidelines for treatment of bone health, and there are significant variations in clinical practice. This study aims to improve our understanding of bone development following SCD using multiple imaging modalities, which will allow the development of consistent, evidence-based guidelines, thus improving future treatment of these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116034 0
Dr Peter Simm
Address 116034 0
The Royal Children's Hospital
Department of Endocrinology and Diabetes
50 Flemington Road Parkville Victoria 3052
Country 116034 0
Australia
Phone 116034 0
+61 39345 5951
Fax 116034 0
Email 116034 0
[email protected]
Contact person for public queries
Name 116035 0
Miss Jamie Ellis
Address 116035 0
Murdoch Children's Research Institute
Neurodisability and Rehabilitation
50 Flemington Road Parkville Victoria 3052
Country 116035 0
Australia
Phone 116035 0
+61 0422345266
Fax 116035 0
Email 116035 0
[email protected]
Contact person for scientific queries
Name 116036 0
Dr Peter Simm
Address 116036 0
The Royal Children's Hospital
Department of Endocrinology and Diabetes
50 Flemington Road Parkville Victoria 3052
Country 116036 0
Australia
Phone 116036 0
+61 39345 5951
Fax 116036 0
Email 116036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data underlying the results reported, following de-identification, may be shared.
When will data be available (start and end dates)?
Data will be available for 5 years following analysis and article publication of this study.
Available to whom?
Data will be made available long-term for use by future researchers in the paediatric spinal cord disorder field from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee
Available for what types of analyses?
Depending on the number of participants, statistical analyses may be formal but will likely be descriptive. Data may be shared in order to increase n numbers and perform inferential statistics.
How or where can data be obtained?
Correspondence to Jamie Ellis
Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14626Study protocol  [email protected]
14627Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.