Early Intervention to Reduce Bone Loss After Spinal Cord Injury

NCT02334410 | Unknown

• 1 other identifier: UEC14/57
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Osteoporosis

Keywords

fractures; immobilisation; paraplegia; tetraplegia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Correlation between imaging and biochemical markers of bone health

  12 months

Study Arms (2)

Reference

NO INTERVENTION

Whole body vibration (WBV)

EXPERIMENTAL

Vibration therapy

Device: Whole body vibration (WBV)

Interventions

Whole body vibration (WBV) DEVICE

Side-alternating WBV

Also known as: Galileo (Novotec Medizintechnik)

Whole body vibration (WBV)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor-complete spinal cord injury (SCI)
• SCI at neurological levels C4 and below
• Within six weeks of SCI

You may not qualify if:

• Recent bilateral fractures in tibia and/or femur
• Previously diagnosed osteoporosis
• Pregnancy

Sponsors & Collaborators

• University of Strathclyde: lead
• Queen Elizabeth National Spinal Injuries Unit, Glasgow: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, G514TF, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Osteoporosis; Fractures, Bone; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

GB (1)