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The effect of spinal cord disorders on bone health in children

A study of bone characteristics in paediatric spinal cord disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000135718
Enrollment
10
Registered
2022-01-27
Start date
2022-08-18
Completion date
2024-02-15
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 performe

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.

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 bone imaging component will involve two separate scans at the study visit - peripheral quantitative computed tomography (pQCT) scan and a dual energy X-ray absorptiometry (DXA) scan. Both scan types have an anticipated d

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 bone imaging component will involve two separate scans at the study visit - peripheral quantitative computed tomography (pQCT) scan and a dual energy X-ray absorptiometry (DXA) scan. 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. The blood draws are anticipated to take 5 minutes. Participants will also be asked to complete questionnaires at the 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.

Sponsors

Murdoch Children's Research Institute
Lead SponsorOther Collaborative groups

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026