Bone-biomarkers of Spinal Cord Injury Patients

Sponsor

Yeungnam University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04403256

Collaborator

(none)

Enrollment

Location

18.8

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Bone Resorption Osteoporosis

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

64 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.

Actual Study Start Date :

Feb 5, 2020

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Aug 30, 2021

Outcome Measures

Primary Outcome Measures

Serum sclerostin level [1 year]
Serum sclerostin level in spinal cord injury patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

history of using bone absorption medication within the effective period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yeungnam University Hospital	Daegu		Korea, Republic of	42415

Sponsors and Collaborators

Yeungnam University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong Gyu Lee, Assistant professor, Yeungnam University Hospital

ClinicalTrials.gov Identifier:

NCT04403256

Other Study ID Numbers:

2019-11-054-001

First Posted:

May 27, 2020

Last Update Posted:

Aug 31, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dong Gyu Lee, Assistant professor, Yeungnam University Hospital

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2021