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Early Intervention to Reduce Bone Loss After Spinal Cord Injury

NCT02334410 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-01-08

No results posted yet for this study

Summary

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

Interventions

DEVICE

Whole body vibration (WBV)

Side-alternating WBV

Sponsors & Collaborators

  • Queen Elizabeth National Spinal Injuries Unit, Glasgow

    collaborator UNKNOWN

  • University of Strathclyde

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-01-31
Completion
2018-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334410 on ClinicalTrials.gov