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CompletedNCT04403256Updated Aug 31, 2021

Bone-biomarkers of Spinal Cord Injury Patients

An observational study in Spinal Cord Injuries, Bone Resorption and Osteoporosis, sponsored by Yeungnam University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Yeungnam University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
64
Ages
20 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Bone Resorption
  • Osteoporosis

Keywords

  • Sclerostin
  • osteoporosis
  • Spinal cord injury
  • Unloading
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Yeungnam University Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with spinal cord injury difficult to walk

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • spinal cord injury patients
  • Functional ambulatory category index of 3 or less

Exclusion criteria

Exclusion Criteria:

  • history of using bone absorption medication within the effective period
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
64 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Serum sclerostin level

    Serum sclerostin level in spinal cord injury patients

    Time frame: 1 year

07

Study locations

1 site
  • Yeungnam University Hospital
    Daegu, 42415, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Aug 2021, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2020
First posted
May 27, 2020
StartActual
Feb 5, 2020
Primary completionActual
Aug 30, 2021
CompletionActual
Aug 30, 2021
Last update
Aug 31, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04403256
Lead sponsor
Yeungnam University Hospital
Responsible party
Dong Gyu Lee (Assistant professor, Yeungnam University Hospital) — Principal investigator
First posted
May 27, 2020
Start date
Feb 5, 2020
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021
Last update
Aug 31, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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