<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/NCT02995798</url>
  </required_header>
  <id_info>
    <org_study_id>Anatomy C-Spine</org_study_id>
    <nct_id>NCT02995798</nct_id>
  </id_info>
  <brief_title>The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD</brief_title>
  <official_title>The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangneung Asan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gangneung Asan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the&#xD;
      cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April&#xD;
      2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year&#xD;
      (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any&#xD;
      destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral&#xD;
      mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score&#xD;
      ≥-1; Group B, -2.5&lt;T-score&lt;-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients,&#xD;
      Group B had lower normal patients including osteopenic patients and Group C presented&#xD;
      osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU,&#xD;
      the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the&#xD;
      medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the&#xD;
      axial CT images in clinical images.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cortical bone Thickness</measure>
    <time_frame>two weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>HU number</measure>
    <time_frame>two weeks</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">99</enrollment>
  <condition>Cortical Bone Thickness</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>T-score ≥-1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>-2.5&lt;T-score&lt;-1.0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>T-score≤-2.5</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cortical Bone thickness and Hounsfield unit (HU) numbers</intervention_name>
    <description>Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the&#xD;
        cervical CT and BMD simultaneously (the gap of both studies was within 6 months)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies&#xD;
             was within 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Who had any destructive pathology or severe spondylosis in the cervical pedicle and&#xD;
             the cervical lateral mass.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Moon-Kyu Kim</name>
      <address>
        <city>Gangneung</city>
        <state>Kangwondo</state>
        <zip>25440</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangneung Asan Hospital</investigator_affiliation>
    <investigator_full_name>Moon-Kyu Kim, MD, Ph.D</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT02995798
org study id: Anatomy C-Spine
nct id: NCT02995798
lead sponsor: 
collaborator: 
has dmc: No
Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the
      cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April
      2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year
      (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any
      destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral
      mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score
      ≥-1; Group B, -2.5<T-score<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients,
      Group B had lower normal patients including osteopenic patients and Group C presented
      osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU,
      the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the
      medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the
      axial CT images in clinical images.
observational model: Case-Control
time perspective: Retrospective
measure: Cortical bone Thickness
time frame: two weeks
measure: HU number
time frame: two weeks
arm group label: Group A
description: T-score ≥-1
arm group label: Group B
description: -2.5<T-score<-1.0
arm group label: Group C
description: T-score≤-2.5
intervention type: Other
intervention name: Cortical Bone thickness and Hounsfield unit (HU) numbers
description: Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
arm group label: Group A
arm group label: Group B
arm group label: Group C
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangneung Asan Hospital
investigator full name: Moon-Kyu Kim, MD, Ph.D
investigator title: Professor
sharing ipd: Undecided