ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal Cord Disorder

Bone development

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

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]

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]

Volumetric Bone Mineral Density (vBMD) at the tibial 4% site (ankle) (measured by peripheral quantitative computed tomography (pQCT))

Timepoint [1]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Primary outcome [2]

Bone geometry at the tibial 4% site (ankle) (measured by peripheral quantitative computed tomography (pQCT))

Timepoint [2]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Primary outcome [3]

Bone mineral content (measured by dual x-ray absorptiometry (DXA)

Timepoint [3]

At enrolment, and at 12 and 24 months post-enrolment

Secondary outcome [1]

PRIMARY OUTCOME: Bone mineral density (measured by dual x-ray absorptiometry (DXA)

Timepoint [1]

At enrolment, and at 12 and 24 months post-enrolment

Secondary outcome [2]

pQCT: vBMD of the tibial 66% site (shin)

Timepoint [2]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [3]

pQCT: bone cross sectional area of tibia

Timepoint [3]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [4]

pQCT: bone cross sectional area of radius

Timepoint [4]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [5]

pQCT: muscle cross sectional area of gastrocnemius

Timepoint [5]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [6]

pQCT: bone mineral content of tibia

Timepoint [6]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [7]

pQCT: bone mineral content of radius

Timepoint [7]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [8]

pQCT: Bending strength of radius

Timepoint [8]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [9]

pQCT: Bending strength of tibia

Timepoint [9]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [10]

Blood Calcium levels

Timepoint [10]

At enrolment, at 6, 12 and 24 months post-enrolment

Secondary outcome [11]

Blood Phosphate levels

Timepoint [11]

At enrolment, at 6, 12 and 24 months post-enrolment

Secondary outcome [12]

Blood Vitamin D levels

Timepoint [12]

At enrolment, at 6, 12 and 24 months post-enrolment

Secondary outcome [13]

Blood Alkaline phosphatase levels

Timepoint [13]

At enrolment, at 6, 12 and 24 months post-enrolment

Secondary outcome [14]

Pain assessment tool for children aged 0-3: FLACC Scale

Timepoint [14]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [15]

Pain assessment tool for children aged 3-12: FPS-R

Timepoint [15]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [16]

Pain assessment tool for children aged 12-18: Verbal Numeric Rating Scale

Timepoint [16]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [17]

Pain assessment tool for all children: International Spinal Cord Injury Pain Classification

Timepoint [17]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [18]

Activity assessment tool for all children: Pediatric Spinal Cord Injury Activity Measures Short Form

Timepoint [18]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [19]

Activity assessment tool for all children: Walking Index for Spinal Cord Injury II

Timepoint [19]

At enrolment, and at 6, 12, 18 and 24 months post-enrolment

Secondary outcome [20]

Participation assessment tool for all children: Pediatric Measure of Participation Short Form

Timepoint [20]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Royal Children's Hospital

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Murdoch Children's Research Institute

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Royal Children’s Hospital Human Research Ethics Committee

Ethics committee address [1]

50 Flemington Rd, Parkville VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2022

Approval date [1]

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Peter Simm

Address

The Royal Children's Hospital Department of Endocrinology and Diabetes 50 Flemington Road Parkville Victoria 3052

Country

Australia

Phone

+61 39345 5951

Fax

Peter.Simm@rch.org.au

Contact person for public queries

Name

Jamie Ellis

Address

Murdoch Children's Research Institute Neurodisability and Rehabilitation 50 Flemington Road Parkville Victoria 3052

Country

Australia

Phone

+61 0422345266

Fax

jamie.ellis@mcri.edu.au

Contact person for scientific queries

Name

Peter Simm

Address

The Royal Children's Hospital Department of Endocrinology and Diabetes 50 Flemington Road Parkville Victoria 3052

Country

Australia

Phone

+61 39345 5951

Fax

Peter.Simm@rch.org.au

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• 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

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual data underlying the results reported, following de-identification, may be shared.

What types of analyses could be done with individual participant data?

• 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.

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available for 5 years following analysis and article publication of this study.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Correspondence to Jamie Ellis
Email: jamie.ellis@mcri.edu.au

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14626	Study protocol			jamie.ellis@mcri.edu.au
14627	Informed consent form			jamie.ellis@mcri.edu.au

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.

Trial Review

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