<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/NCT04413448</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI083</org_study_id>
    <nct_id>NCT04413448</nct_id>
  </id_info>
  <brief_title>Performance of CT Parameters Compared to Bone Mineral Density to Detect Bone Fragility in Rheumatoid Arthritis</brief_title>
  <official_title>Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</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>
      Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis)&#xD;
      compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the performance of scanographic bone attenuation coefficient of the first lumbar&#xD;
      vertebra (SBAC-L1) and fractal analysis, markers of bone fragility on computed tomography&#xD;
      (CT), compared to bone mineral density (BMD) to detect vertebral fractures in rheumatoid&#xD;
      arthritis (RA).&#xD;
&#xD;
      Patient and methods: Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy&#xD;
      University hospital who met the 2010 ACR/EULAR criteria for RA and examined using&#xD;
      thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years&#xD;
      were included. Scanographic bone attenuation coefficient and fractal dimension of the first&#xD;
      lumbar vertebra (SBAC-L1, FD-L1) were measured on CT. Vertebral fractures of the&#xD;
      thoracolumbar spine were evaluated on CT according to an adaptation of Genant's scoring&#xD;
      method.&#xD;
&#xD;
      Demographic characteristics (age, sex, smoking), clinical data (disease duration, DAS-28),&#xD;
      biological data (C-reactive protein (CRP), RF, ACPA) and treatments (n proton pump inhibitor,&#xD;
      corticosteroid, TNF-inhibitors (TNFi) and others biologics, calcium, vitamin D,&#xD;
      antiresorptive agents) were collected from the complete medical record. Univariate and&#xD;
      multivariate analysis were performed to determine if these variables were associated or not&#xD;
      with bone fragility (vertebral fracture, SBAC-L1, FD-L1).&#xD;
&#xD;
      We evaluated the performance and diagnostic complementarity as well as optimal diagnostic&#xD;
      thresholds of SBAC-L1, FD-L1 and BMD (gold standard) to detect vertebral fractures in these&#xD;
      patients at risk of osteoporosis.&#xD;
&#xD;
      Intra and inter-readers reproducibilities of the scanographic screening methods (SBAC-L1,&#xD;
      FD-L1) were also studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of SBAC-L1 to detect the presence of vertebral fracture on CT</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance of FD-L1 to detect the presence of vertebral fracture on CT</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)</measure>
    <time_frame>4 month</time_frame>
    <description>Correlation between demographic (age, sexe, osteoporotic factors), clinical (disease duration, disease activity) biologic (CRP, ACPA, Rheumatoid Factor) and treatments (corticosteroids, biologic, DMARDs, anti-osteoporotic) and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">260</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Vertebral Fracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who&#xD;
        met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT&#xD;
        (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital&#xD;
             who met the 2010 ACR/EULAR criteria for RA&#xD;
&#xD;
          -  Thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2&#xD;
             years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damien Loeuille, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>+33662436967</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Nancy</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <state>Meurthe-et-Moselle</state>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1007/s00774-013-0465-6</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://link.springer.com/10.1007/s198-002-8335-4</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://link.springer.com/10.1007/s00198-007-0532-8</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04413448
org study id: 2020PI083
nct id: NCT04413448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis)
      compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis
To evaluate the performance of scanographic bone attenuation coefficient of the first lumbar
      vertebra (SBAC-L1) and fractal analysis, markers of bone fragility on computed tomography
      (CT), compared to bone mineral density (BMD) to detect vertebral fractures in rheumatoid
      arthritis (RA).

      Patient and methods: Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy
      University hospital who met the 2010 ACR/EULAR criteria for RA and examined using
      thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years
      were included. Scanographic bone attenuation coefficient and fractal dimension of the first
      lumbar vertebra (SBAC-L1, FD-L1) were measured on CT. Vertebral fractures of the
      thoracolumbar spine were evaluated on CT according to an adaptation of Genant's scoring
      method.

      Demographic characteristics (age, sex, smoking), clinical data (disease duration, DAS-28),
      biological data (C-reactive protein (CRP), RF, ACPA) and treatments (n proton pump inhibitor,
      corticosteroid, TNF-inhibitors (TNFi) and others biologics, calcium, vitamin D,
      antiresorptive agents) were collected from the complete medical record. Univariate and
      multivariate analysis were performed to determine if these variables were associated or not
      with bone fragility (vertebral fracture, SBAC-L1, FD-L1).

      We evaluated the performance and diagnostic complementarity as well as optimal diagnostic
      thresholds of SBAC-L1, FD-L1 and BMD (gold standard) to detect vertebral fractures in these
      patients at risk of osteoporosis.

      Intra and inter-readers reproducibilities of the scanographic screening methods (SBAC-L1,
      FD-L1) were also studied.
observational model: Other
time perspective: Retrospective
measure: Performance of SBAC-L1 to detect the presence of vertebral fracture on CT
time frame: 4 months
measure: Performance of FD-L1 to detect the presence of vertebral fracture on CT
time frame: 4 months
measure: ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)
time frame: 1 month
measure: Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)
time frame: 4 month
description: Correlation between demographic (age, sexe, osteoporotic factors), clinical (disease duration, disease activity) biologic (CRP, ACPA, Rheumatoid Factor) and treatments (corticosteroids, biologic, DMARDs, anti-osteoporotic) and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)
measure: ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Damien Loeuille, MD-PhD
role: Principal Investigator
affiliation: +33662436967
facility: 
country: France
url: https://doi.org/10.1007/s00774-013-0465-6
description: Related Info
url: http://link.springer.com/10.1007/s198-002-8335-4
description: Related Info
url: http://link.springer.com/10.1007/s00198-007-0532-8
description: Related Info
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Osteoporosis
mesh term: Spinal Fractures
sharing ipd: No