Early Intervention to Reduce Bone Loss After Spinal Cord Injury

January 6, 2015 updated by: Sylvie Coupaud, University of Strathclyde
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G514TF
        • Queen Elizabeth National Spinal Injuries Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Reference
Experimental: Whole body vibration (WBV)
Vibration therapy
Device: Whole body vibration (WBV)
Side-alternating WBV
Other Names:
  • Galileo (Novotec Medizintechnik)

What is the study measuring?

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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Imaging-derived data will be compared with analyses of blood samples as indicators of bone health
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Strathclyde

Collaborators

Queen Elizabeth National Spinal Injuries Unit, Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEC14/57

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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