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Early Intervention to Reduce Bone Loss After Spinal Cord Injury

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02334410
Enrollment
60
Registered
2015-01-08
Start date
2015-02-28
Completion date
2018-02-28
Last updated
2015-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Spinal Cord Injury

Keywords

fractures, immobilisation, paraplegia, tetraplegia

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.

Interventions

Side-alternating WBV

Sponsors

Queen Elizabeth National Spinal Injuries Unit, Glasgow
CollaboratorUNKNOWN
University of Strathclyde
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans12 monthsCan 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 samples12 monthsBiochemical markers of bone formation, bone resorption, hormone and mineral levels.

Secondary

MeasureTime frameDescription
Correlation between imaging and biochemical markers of bone health12 monthsImaging-derived data will be compared with analyses of blood samples as indicators of bone health

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026