<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04403256</url>
  </required_header>
  <id_info>
    <org_study_id>2019-11-054-001</org_study_id>
    <nct_id>NCT04403256</nct_id>
  </id_info>
  <brief_title>Bone-biomarkers of Spinal Cord Injury Patients</brief_title>
  <official_title>Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic&#xD;
      skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed.&#xD;
      In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high&#xD;
      therapeutic effect as an inhibitor of bone resorption while promoting bone formation.&#xD;
      However, there are a few research concerning sclerostin of spinal cord injuries patients.&#xD;
      Therefore we want to analyze the change of sclerostin as well as factors indicating bone&#xD;
      formation and absorption marker in spinal cord injury patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Serum sclerostin level</measure>
    <time_frame>1 year</time_frame>
    <description>Serum sclerostin level in spinal cord injury patients</description>
  </primary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Bone Resorption</condition>
  <condition>Osteoporosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with spinal cord injury difficult to walk&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  spinal cord injury patients&#xD;
&#xD;
          -  Functional ambulatory category index of 3 or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of using bone absorption medication within the effective period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yeungnam University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>42415</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>March 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University Hospital</investigator_affiliation>
    <investigator_full_name>Dong Gyu Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Sclerostin</keyword>
  <keyword>osteoporosis</keyword>
  <keyword>Spinal cord injury</keyword>
  <keyword>Unloading</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Bone Resorption</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403256
org study id: 2019-11-054-001
nct id: NCT04403256
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Serum sclerostin level
time frame: 1 year
description: Serum sclerostin level in spinal cord injury patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University Hospital
investigator full name: Dong Gyu Lee
investigator title: Assistant professor
mesh term: Osteoporosis
mesh term: Bone Resorption
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: Undecided