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NCT04403256 Clinical Trial

Bone-biomarkers of Spinal Cord Injury Patients

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04403256
Other study ID # 2019-11-054-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2020
Est. completion date August 30, 2021

Study information
Verified date August 2021
Source Yeungnam University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Yeungnam University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum sclerostin level Serum sclerostin level in spinal cord injury patients 1 year
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