<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/NCT03251430</url>
  </required_header>
  <id_info>
    <org_study_id>17061943</org_study_id>
    <nct_id>NCT03251430</nct_id>
  </id_info>
  <brief_title>Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy</brief_title>
  <official_title>Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kobayashi Shinichiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nagasaki University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the&#xD;
      deterioration of bone architecture, is a serious complication in the long course after&#xD;
      gastrectomy. The aim of the present study was to evaluate osteoporosis by using&#xD;
      high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course&#xD;
      after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years&#xD;
      should have elapsed since gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy&#xD;
      especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy,&#xD;
      which is characterized by both the loss of bone mass and the deterioration of bone&#xD;
      architecture, is a serious complication in the long course after gastrectomy. The primary&#xD;
      tools for assessing volumetric density and bone structure are quantitative computed&#xD;
      tomography (QCT) and more recently, high-resolution peripheral quantitative computed&#xD;
      tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT in the long course&#xD;
      after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis&#xD;
      by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal&#xD;
      gastrectomy groups, at least 5 years should have elapsed since gastrectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</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 Day</target_duration>
  <primary_outcome>
    <measure>Comparing bone microstructure in control, DG, and TG groups</measure>
    <time_frame>day1</time_frame>
    <description>volumetric bone mineral density</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with sarcopenia</measure>
    <time_frame>day1</time_frame>
    <description>Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with serum biomarkers of osteoporosis</measure>
    <time_frame>day1</time_frame>
    <description>Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with dual-energy X-ray absorptiometry</measure>
    <time_frame>day1</time_frame>
    <description>Correlation of bone mineral density between HR-pQCT and DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with quality of life (QOL-C30)</measure>
    <time_frame>day1</time_frame>
    <description>Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with quality of life (BDHQ)</measure>
    <time_frame>day1</time_frame>
    <description>Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparing bone microstructure with quality of life (FRAX)</measure>
    <time_frame>day1</time_frame>
    <description>Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Sarcopenia</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>38 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distal Gastrectomy (DG) group</arm_group_label>
    <description>38 patients with distal gastrectomy due to gastric cancer before no more than 5 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Total Gastrectomy (TG) group</arm_group_label>
    <description>38 patients with distal gastrectomy due to gastric cancer before no more than 5 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>gastrectomy</intervention_name>
    <description>Distal gastrectomy, Total gastrectomy</description>
    <arm_group_label>Distal Gastrectomy (DG) group</arm_group_label>
    <arm_group_label>Total Gastrectomy (TG) group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Protein&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Japanese&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 5 years have elapsed since DG or TG due to gastric cancer&#xD;
&#xD;
          -  Provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  Current use of the following osteoporosis agents; Teriparatide, Denosumab, and&#xD;
             bisphosphonate&#xD;
&#xD;
          -  Hyperthyroidism&#xD;
&#xD;
          -  Hyperparathyroidism&#xD;
&#xD;
          -  Present malignancy (except in situ carcinoma)&#xD;
&#xD;
          -  Any condition that required chronic (greater than three months cumulative and greater&#xD;
             than 5 mg/day) glucocorticoid therapy&#xD;
&#xD;
          -  Other diseases which affect bone metabolism&#xD;
&#xD;
          -  Any disorder that, in the opinion of the investigator, may compromise the ability of&#xD;
             the subject to give written informed consent and/or comply with study procedures&#xD;
&#xD;
          -  Received &gt; 3 months (or equivalent) of osteoporosis treatment&#xD;
&#xD;
          -  Currently enrolled in or has not yet completed at least 1 month since ending other&#xD;
             investigational device or drug trial(s), or subject is receiving other investigational&#xD;
             agent(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shinichiro Kobayashi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shinichiro Kobayashi, MD</last_name>
    <phone>81958197316</phone>
    <email>shinichirokobayashi@nagasaki-u.ac.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kobayashi Shinichiro, M.D.</last_name>
      <phone>+81958197316</phone>
      <email>shinichirokobayashi@nagasaki-u.ac.jp</email>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nagasaki University</investigator_affiliation>
    <investigator_full_name>Kobayashi Shinichiro</investigator_full_name>
    <investigator_title>Principal Investigator in department of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Sarcopenia</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/NCT03251430
org study id: 17061943
nct id: NCT03251430
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the
      deterioration of bone architecture, is a serious complication in the long course after
      gastrectomy. The aim of the present study was to evaluate osteoporosis by using
      high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course
      after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years
      should have elapsed since gastrectomy.
The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy
      especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy,
      which is characterized by both the loss of bone mass and the deterioration of bone
      architecture, is a serious complication in the long course after gastrectomy. The primary
      tools for assessing volumetric density and bone structure are quantitative computed
      tomography (QCT) and more recently, high-resolution peripheral quantitative computed
      tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT in the long course
      after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis
      by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal
      gastrectomy groups, at least 5 years should have elapsed since gastrectomy.
observational model: Cohort
time perspective: Prospective
measure: Comparing bone microstructure in control, DG, and TG groups
time frame: day1
description: volumetric bone mineral density
measure: Comparing bone microstructure with sarcopenia
time frame: day1
description: Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
measure: Comparing bone microstructure with serum biomarkers of osteoporosis
time frame: day1
description: Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
measure: Comparing bone microstructure with dual-energy X-ray absorptiometry
time frame: day1
description: Correlation of bone mineral density between HR-pQCT and DXA
measure: Comparing bone microstructure with quality of life (QOL-C30)
time frame: day1
description: Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)
measure: Comparing bone microstructure with quality of life (BDHQ)
time frame: day1
description: Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)
measure: Comparing bone microstructure with quality of life (FRAX)
time frame: day1
description: Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)
arm group label: Control group
description: 38 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535)
arm group label: Distal Gastrectomy (DG) group
description: 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years
arm group label: Total Gastrectomy (TG) group
description: 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years
intervention type: Procedure
intervention name: gastrectomy
description: Distal gastrectomy, Total gastrectomy
arm group label: Distal Gastrectomy (DG) group
arm group label: Total Gastrectomy (TG) group
Protein
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shinichiro Kobayashi, MD
role: Principal Investigator
affiliation: Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
last name: Shinichiro Kobayashi, MD
phone: 81958197316
email: shinichirokobayashi@nagasaki-u.ac.jp
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor-Investigator
investigator affiliation: Nagasaki University
investigator full name: Kobayashi Shinichiro
investigator title: Principal Investigator in department of Surgery
mesh term: Osteoporosis
mesh term: Sarcopenia
sharing ipd: No