<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/NCT02220322</url>
  </required_header>
  <id_info>
    <org_study_id>IRB TH No 9</org_study_id>
    <nct_id>NCT02220322</nct_id>
  </id_info>
  <brief_title>Age-related Cognitive Change of Femur</brief_title>
  <official_title>Age-related Cognitive Change of Femur</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomidahama Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomidahama Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Age-related change of femur is not well-known. The investigators investigated the&#xD;
      longitudinal changes of femur.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, bisphosphonate-related atypical fracture of femur (AFF) is paid attention in&#xD;
      clinicians. Almost all AFFs were occurred in thicker cortical thickness. But age-related&#xD;
      change of femur is not well-known.&#xD;
&#xD;
      The main objective of this study is to reveal the age-related change of femur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Age-related change of femur</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>We investigate radiographic features in patients with osteopenia/opsteoporosis. We investigate bilateral femur radiographs concerning to cortical thickening. We analyze age-related change of femur.&#xD;
To determine the age-related change of femur , statistical analyses are performed using Spearman correlation, paired t-test, chi-square test, Fisher's exact test and Mann-Whitney U test. Finally, we conclude the effects of age on femur.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Osteoporosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Osteoporosis or osteopenia patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Osteoporosis or osteopenia patients who presented to our hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without osteoporosis or osteopenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rui Niimi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tomidahama Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rui Niimi, MD, PhD</last_name>
    <phone>(81)-59-365-0023</phone>
    <email>furikakefuri@hotmail.co.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tomidahama Hospital</name>
      <address>
        <city>Yokkaichi</city>
        <state>Mie</state>
        <zip>510-8008</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Niimi, MD, PhD</last_name>
      <phone>(81)-59-365-0023</phone>
      <email>furikakefuri@hotmail.co.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>October 18, 2016</last_update_submitted>
  <last_update_submitted_qc>October 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tomidahama Hospital</investigator_affiliation>
    <investigator_full_name>Toshihiko Kono</investigator_full_name>
    <investigator_title>Head of Hospital</investigator_title>
  </responsible_party>
  <keyword>cortical thickness</keyword>
  <keyword>age</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02220322
org study id: IRB TH No 9
nct id: NCT02220322
lead sponsor: 
has dmc: No
Age-related change of femur is not well-known. The investigators investigated the
      longitudinal changes of femur.
Recently, bisphosphonate-related atypical fracture of femur (AFF) is paid attention in
      clinicians. Almost all AFFs were occurred in thicker cortical thickness. But age-related
      change of femur is not well-known.

      The main objective of this study is to reveal the age-related change of femur.
observational model: Cohort
time perspective: Prospective
measure: Age-related change of femur
time frame: Up to 12 months
description: We investigate radiographic features in patients with osteopenia/opsteoporosis. We investigate bilateral femur radiographs concerning to cortical thickening. We analyze age-related change of femur.
To determine the age-related change of femur , statistical analyses are performed using Spearman correlation, paired t-test, chi-square test, Fisher's exact test and Mann-Whitney U test. Finally, we conclude the effects of age on femur.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rui Niimi, PhD
role: Principal Investigator
affiliation: Tomidahama Hospital
last name: Rui Niimi, MD, PhD
phone: (81)-59-365-0023
email: furikakefuri@hotmail.co.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Tomidahama Hospital
investigator full name: Toshihiko Kono
investigator title: Head of Hospital
mesh term: Osteoporosis