Spinal Cord InjuryNCT01853488
Bone Strength After Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Background: After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- DXA and pQCT
- Type of treatment
- Surgery or procedure
- How many people
- 273 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2010to Nov 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the Swiss Paraplegic Centre Nottwil (in-patient or out-patient).
Who may be able to join
- Spinal Cord Injury
- mobilized patients
- written informed consent
Who cannot join
- current fracture
- limited mobility
- contractures of the lower limbs
- decubitus ulcer
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic-Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.
Background:
After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.
Read more
Aims:
To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.
Subjects:
250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.
Methods:
Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.
- Conditions
- Spinal Cord Injury
- Being tested
- DXA, pQCT
- Keywords
- Osteoporosis, BMD, SCI, DXA, pQCT
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXARadiation
Osteodensitometry
pQCTRadiation
Osteodensitometry
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Persons with spinal cord injury Osteodensitometry DXA pQCT Receives: Radiation: DXA; Radiation: pQCT | |
| Reference | Reference population (able-bodied) Osteodensitometry DXA pQCT Receives: Radiation: DXA; Radiation: pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone parameters
Measurement of the extremities with DEXA and pQCT
Measured: just one timepoint
Secondary outcomes (1)
Fractures
Number of fractures since SCI
Measured: just one timepoint (questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startOct 2010
- Primary completionNov 2015
- Study completionNov 2015
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Angela Frotzler, PhD, Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853488
- Sponsor's protocol ID
- 2010-13
- Status last verified
- Nov 2015
- First submitted
- 2 May 2013
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.
- ClinicalTrials.gov ID
- NCT01853488
- Acronym / sponsor ID
- 2010-13
- Conditions
- Spinal Cord Injury
- Keywords
- Osteoporosis, BMD, SCI, DXA, pQCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Oct 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 May 2013 (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.
Background:
After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.
Aims:
To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.
Subjects:
250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.
Methods:
Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | Radiation: DXA, Radiation: pQCTPersons with spinal cord injury Osteodensitometry DXA pQCT |
| Reference | – | Radiation: DXA, Radiation: pQCTReference population (able-bodied) Osteodensitometry DXA pQCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Swiss Paraplegic Centre Nottwil (in-patient or out-patient).
Key inclusion criteria (3 listed)
- Spinal Cord Injury
- mobilized patients
- written informed consent
Key exclusion criteria (5 listed)
- current fracture
- limited mobility
- contractures of the lower limbs
- decubitus ulcer
- 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 |
|---|---|---|
| DXAOsteodensitometry | Radiation | Reference, Spinal Cord Injury |
| pQCTOsteodensitometry | Radiation | Reference, Spinal Cord Injury |
Primary outcome
Bone parameters
Time frame: just one timepoint
Measurement of the extremities with DEXA and pQCT
1 secondary outcome
Fractures
Time frame: just one timepoint (questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Swiss Paraplegic Centre NottwilLink provided by the sponsor.
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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.
Angela Frotzler, PhD principal investigator
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 5 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: finished, as of the sponsor's last update on 13 Feb 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone parameters (time frame: just one timepoint). 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 13 Feb 2024.