Early Intervention to Reduce Bone Loss After Spinal Cord Injury

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02334410
• Other study ID #: UEC14/57
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 6, 2015
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: January 2015
• Source: University of Strathclyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Whole body vibration (WBV)
Side-alternating WBV

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth National Spinal Injuries Unit	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Strathclyde	Queen Elizabeth National Spinal Injuries Unit, Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No