Spinal Cord InjuriesNCT04403256
Bone-biomarkers of Spinal Cord Injury Patients
An observational study of Spinal Cord Injuries and Bone Resorption, run by Yeungnam University Hospital at 1 site in South Korea.
Trial summary
Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Cord Injuries, Bone Resorption, Osteoporosis
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2020to 30 Aug 2021
- How long will I take part?
- 1 Day
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spinal cord injury difficult to walk
Who may be able to join
- spinal cord injury patients
- Functional ambulatory category index of 3 or less
Who cannot join
- history of using bone absorption medication within the effective period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.
Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.
- Conditions
- Spinal Cord Injuries, Bone Resorption, Osteoporosis
- Keywords
- Sclerostin, osteoporosis, Spinal cord injury, Unloading
- Medical subject headings
- Spinal Cord Injuries, Bone Resorption, Osteoporosis, Sclerosteosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sclerostin level
Serum sclerostin level in spinal cord injury patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start5 Feb 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Gyu Lee, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403256
- Sponsor's protocol ID
- 2019-11-054-001
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT04403256
- Acronym / sponsor ID
- 2019-11-054-001
- Conditions
- Spinal Cord Injuries, Bone Resorption, Osteoporosis
- Keywords
- Sclerostin, osteoporosis, Spinal cord injury, Unloading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 27 May 2020 (actual)
- 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.
Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal cord injury difficult to walk
Key inclusion criteria (2 listed)
- spinal cord injury patients
- Functional ambulatory category index of 3 or less
Key exclusion criteria (1 listed)
- history of using bone absorption medication within the effective period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum sclerostin level
Time frame: 1 year
Serum sclerostin level in spinal cord injury patients
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 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Spinal Cord Injuries and Bone Resorption, run by Yeungnam University Hospital at 1 site in South Korea.
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 2 inclusion and 1 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 31 Aug 2021. 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 South Korea. 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?
Serum sclerostin level (time frame: 1 year). 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 31 Aug 2021.