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Bone-biomarkers of Spinal Cord Injury Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403256
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Dong Gyu Lee, Yeungnam University Hospital

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
Spinal Cord Injuries Bone Resorption Osteoporosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 64 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Serum sclerostin level [ Time Frame: 1 year ]
    Serum sclerostin level in spinal cord injury patients



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spinal cord injury difficult to walk
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403256


Locations
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Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: Dong gyu Lee, M.D., Ph.D.    82536203829    painfree@yu.ac.kr   
Sponsors and Collaborators
Yeungnam University Hospital
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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    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Gyu Lee, Yeungnam University Hospital:
Sclerostin
osteoporosis
Spinal cord injury
Unloading
Additional relevant MeSH terms:
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Osteoporosis
Bone Resorption
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases