Early Intervention to Reduce Bone Loss After Spinal Cord Injury

Study Overview
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Brief Summary
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After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and red-flag those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.

Conditions
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Spinal Cord Injury, Osteoporosis

Intervention / Treatment
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* Device: Whole body vibration (WBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Motor-complete spinal cord injury (SCI) SCI at neurological levels C4 and below Within six weeks of SCI Exclusion Criteria: Recent bilateral fractures in tibia and/or femur Previously diagnosed osteoporosis Pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Reference<br> | |
| Experimental: Whole body vibration (WBV)<br>Vibration therapy | Device: Whole body vibration (WBV)<br>* Side-alternating WBV<br>* Other names: Galileo (Novotec Medizintechnik);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans | Can WBV intervention reduce the rate of bone loss in patients with early spinal cord injury? | 12 months | 
| Rate of change of calcium and bone profiles based on blood samples | Biochemical markers of bone formation, bone resorption, hormone and mineral levels. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between imaging and biochemical markers of bone health | Imaging-derived data will be compared with analyses of blood samples as indicators of bone health | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractures, immobilisation, paraplegia, tetraplegia