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Early Intervention to Reduce Bone Loss After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whole body vibration (WBV)
Sponsored by
University of Strathclyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring fractures, immobilisation, paraplegia, tetraplegia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth National Spinal Injuries Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Reference

Whole body vibration (WBV)

Arm Description

Vibration therapy

Outcomes

Primary Outcome Measures

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?
Rate of change of calcium and bone profiles based on blood samples
Biochemical markers of bone formation, bone resorption, hormone and mineral levels.

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2015
Last Updated
January 6, 2015
Sponsor
University of Strathclyde
Collaborators
Queen Elizabeth National Spinal Injuries Unit, Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02334410
Brief Title
Early Intervention to Reduce Bone Loss After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Strathclyde
Collaborators
Queen Elizabeth National Spinal Injuries Unit, Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Osteoporosis
Keywords
fractures, immobilisation, paraplegia, tetraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reference
Arm Type
No Intervention
Arm Title
Whole body vibration (WBV)
Arm Type
Experimental
Arm Description
Vibration therapy
Intervention Type
Device
Intervention Name(s)
Whole body vibration (WBV)
Other Intervention Name(s)
Galileo (Novotec Medizintechnik)
Intervention Description
Side-alternating WBV
Primary Outcome Measure Information:
Title
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans
Description
Can WBV intervention reduce the rate of bone loss in patients with early spinal cord injury?
Time Frame
12 months
Title
Rate of change of calcium and bone profiles based on blood samples
Description
Biochemical markers of bone formation, bone resorption, hormone and mineral levels.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Correlation between imaging and biochemical markers of bone health
Description
Imaging-derived data will be compared with analyses of blood samples as indicators of bone health
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
ZIP/Postal Code
G514TF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariel Purcell
First Name & Middle Initial & Last Name & Degree
Alan McLean

12. IPD Sharing Statement

Learn more about this trial

Early Intervention to Reduce Bone Loss After Spinal Cord Injury

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