<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/NCT03006003</url>
  </required_header>
  <id_info>
    <org_study_id>CE16256A</org_study_id>
    <nct_id>NCT03006003</nct_id>
  </id_info>
  <brief_title>Osteoporosis Treatment in Post-menopausal Women</brief_title>
  <official_title>The Assessment of Osteoporosis Treatment in Post-menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be conducted to assess the depressive symptoms and related markers in the&#xD;
      postmenopausal female after anti-osteoporosis treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fracture is one of the important complications in female. Osteoporosis should be treated in&#xD;
      postmenopausal female due to high risk of fracture. Recently, there have been many classes of&#xD;
      medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis&#xD;
      medication, has been reported to improved central nervous disorders. Therefore, this study is&#xD;
      designed to assess the depressive symptoms and related markers in the postmenopausal female&#xD;
      after anti-osteoporosis treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain-derived neurotrophic factor</measure>
    <time_frame>3 months</time_frame>
    <description>Serum brain-derived neurotrophic factor (BDNF) Levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain-derived neurotrophic factor</measure>
    <time_frame>1 year</time_frame>
    <description>Serum brain-derived neurotrophic factor (BDNF) Levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular cell adhesion molecule-1</measure>
    <time_frame>3 months</time_frame>
    <description>Serum vascular cell adhesion molecule-1 (VCAM-1) levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orexin-A</measure>
    <time_frame>3 months</time_frame>
    <description>Serum Orexin-A levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body components</measure>
    <time_frame>3 months</time_frame>
    <description>Fat tissue ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zung self-rating depression scale</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire for depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-Item Geriatric Depression Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire for Cognitive assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Mini Mental State Examination (MMSE)</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire for Cognitive assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Barthel index</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire for Cognitive assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Activities of Daily Living (IADL)</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire for Cognitive assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ankle-brachial index</measure>
    <time_frame>3 months</time_frame>
    <description>Peripheral artery disease assessment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Depressive Syndrome</condition>
  <arm_group>
    <arm_group_label>Raloxifene group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Raloxifene treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alendronate treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To refuse anti-osteoporosis treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Raloxifene</intervention_name>
    <description>Raloxifene tratment more than 4 weeks</description>
    <arm_group_label>Raloxifene group</arm_group_label>
    <other_name>Evista</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alendronate</intervention_name>
    <description>Alendronic acid 70mg with Colecalciferol 70mcg</description>
    <arm_group_label>Comparator group</arm_group_label>
    <other_name>FOSAMAX PLUS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal female&#xD;
&#xD;
          -  Osteoporosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychological disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>I-Te Lee, MD, PhD</last_name>
    <phone>+886-4-23741300</phone>
    <email>itlee@vghtc.gov.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>I-Te Lee, MD, PhD</last_name>
    <email>itlee@vghtc.gov.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I Te Lee, MD</last_name>
      <phone>886-4-23741340</phone>
      <email>itlee@vghtc.gov.tw</email>
    </contact>
    <investigator>
      <last_name>I Te Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Te Lee, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoporosis</keyword>
  <keyword>Raloxifene</keyword>
  <keyword>Central nervous disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alendronate</mesh_term>
    <mesh_term>Raloxifene Hydrochloride</mesh_term>
  </intervention_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/NCT03006003
org study id: CE16256A
nct id: NCT03006003
lead sponsor: 
has dmc: No
The study will be conducted to assess the depressive symptoms and related markers in the
      postmenopausal female after anti-osteoporosis treatment.
Fracture is one of the important complications in female. Osteoporosis should be treated in
      postmenopausal female due to high risk of fracture. Recently, there have been many classes of
      medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis
      medication, has been reported to improved central nervous disorders. Therefore, this study is
      designed to assess the depressive symptoms and related markers in the postmenopausal female
      after anti-osteoporosis treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Brain-derived neurotrophic factor
time frame: 3 months
description: Serum brain-derived neurotrophic factor (BDNF) Levels
measure: Brain-derived neurotrophic factor
time frame: 1 year
description: Serum brain-derived neurotrophic factor (BDNF) Levels
measure: Vascular cell adhesion molecule-1
time frame: 3 months
description: Serum vascular cell adhesion molecule-1 (VCAM-1) levels
measure: Orexin-A
time frame: 3 months
description: Serum Orexin-A levels
measure: Body components
time frame: 3 months
description: Fat tissue ratio
measure: Zung self-rating depression scale
time frame: 3 months
description: Questionnaire for depressive symptoms
measure: 5-Item Geriatric Depression Scale
time frame: 3 months
description: Questionnaire for Cognitive assessment
measure: The Mini Mental State Examination (MMSE)
time frame: 3 months
description: Questionnaire for Cognitive assessment
measure: The Barthel index
time frame: 3 months
description: Questionnaire for Cognitive assessment
measure: Instrumental Activities of Daily Living (IADL)
time frame: 3 months
description: Questionnaire for Cognitive assessment
measure: ankle-brachial index
time frame: 3 months
description: Peripheral artery disease assessment
arm group label: Raloxifene group
arm group type: Experimental
description: Raloxifene treatment
arm group label: Comparator group
arm group type: Active Comparator
description: Alendronate treatment
arm group label: Control group
arm group type: No Intervention
description: To refuse anti-osteoporosis treatment
intervention type: Drug
intervention name: Raloxifene
description: Raloxifene tratment more than 4 weeks
arm group label: Raloxifene group
other name: Evista
intervention type: Drug
intervention name: Alendronate
description: Alendronic acid 70mg with Colecalciferol 70mcg
arm group label: Comparator group
other name: FOSAMAX PLUS
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: I-Te Lee, MD, PhD
phone: +886-4-23741300
email: itlee@vghtc.gov.tw
last name: I-Te Lee, MD, PhD
email: itlee@vghtc.gov.tw
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Depressive Disorder
mesh term: Alendronate
mesh term: Raloxifene Hydrochloride
sharing ipd: No