Spinal Cord InjuryNCT02334410
Early Intervention to Reduce Bone Loss After Spinal Cord Injury
A study testing Whole body vibration (WBV) in people with Spinal Cord Injury and Osteoporosis, run by University of Strathclyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury, Osteoporosis
- What is being tested?
- Whole body vibration (WBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Motor-complete spinal cord injury (SCI)
- SCI at neurological levels C4 and below
- Within six weeks of SCI
Who cannot join
- Recent bilateral fractures in tibia and/or femur
- Previously diagnosed osteoporosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow, G514TF
Mariel Purcell
Alan McLean
About this study
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
- Being tested
- Whole body vibration (WBV)
- Keywords
- fractures, immobilisation, paraplegia, tetraplegia
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis, Fractures, Bone, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration (WBV)Device
Also called Galileo (Novotec Medizintechnik)
Side-alternating WBV
| Study group | Role | What they receive |
|---|---|---|
| Reference | No intervention | Not described |
| Whole body vibration (WBV) | Experimental | Vibration therapy Receives: Device: Whole body vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth National Spinal Injuries Unit, Glasgow
- Responsible party
- Principal investigator, Sylvie Coupaud, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334410
- Sponsor's protocol ID
- UEC14/57
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2015
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention to Reduce Bone Loss After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02334410
- Acronym / sponsor ID
- UEC14/57
- Conditions
- Spinal Cord Injury, Osteoporosis
- Keywords
- fractures, immobilisation, paraplegia, tetraplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Collaborators
- Queen Elizabeth National Spinal Injuries Unit, Glasgow
- Study start
- Feb 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | No intervention | – |
| Whole body vibration (WBV) | Experimental | Device: Whole body vibration (WBV)Vibration therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Motor-complete spinal cord injury (SCI)
- SCI at neurological levels C4 and below
- Within six weeks of SCI
Key exclusion criteria (3 listed)
- Recent bilateral fractures in tibia and/or femur
- Previously diagnosed osteoporosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration (WBV)Also: Galileo (Novotec Medizintechnik)Side-alternating WBV | Device | Whole body vibration (WBV) |
Primary outcome
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?
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.
1 secondary outcome
Correlation between imaging and biochemical markers of bone health
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration (WBV) in people with Spinal Cord Injury and Osteoporosis, run by University of Strathclyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.