<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/NCT03755193</url>
  </required_header>
  <id_info>
    <org_study_id>DMAb switch 2018</org_study_id>
    <nct_id>NCT03755193</nct_id>
  </id_info>
  <brief_title>Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients</brief_title>
  <official_title>Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shinshu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shinshu University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to examine the efficacy and adverse events in the following 3 groups&#xD;
      in Japanese osteoporosis patients after 2-year-denosumab therapy:&#xD;
&#xD;
      SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for&#xD;
      24 months Eldecalcitol treatment for 24 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 24, 2018</start_date>
  <completion_date type="Anticipated">November 23, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 23, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone</measure>
    <time_frame>Change from Baseline Values of bone mineral density at 2 years in each group</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>SERM plus ELD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To examine the effects of SERM plus ELD in osteoporosis patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BP plus ELD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To examine the effects of BP plus ELD in osteoporosis patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELD alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To examine the effects of ELD alone in osteoporosis patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SERM &quot;Viviant®Tablet 20mg&quot; and ELD &quot;Edirol®Tablet 0.75ug&quot;</intervention_name>
    <description>To examine the effects of SERM and ELD in osteoporosis patients</description>
    <arm_group_label>BP plus ELD</arm_group_label>
    <arm_group_label>ELD alone</arm_group_label>
    <arm_group_label>SERM plus ELD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisphosphonates and ELD &quot;Edirol®Tablet 0.75ug&quot;</intervention_name>
    <description>To examine the effects of BP and ELD in osteoporosis patients</description>
    <arm_group_label>BP plus ELD</arm_group_label>
    <arm_group_label>ELD alone</arm_group_label>
    <arm_group_label>SERM plus ELD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ELD &quot;Edirol®Tablet 0.75ug&quot;</intervention_name>
    <description>To examine the effects of ELD in osteoporosis patients</description>
    <arm_group_label>BP plus ELD</arm_group_label>
    <arm_group_label>ELD alone</arm_group_label>
    <arm_group_label>SERM plus ELD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  osteoporosis patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not osteoporosis patients who are allergic to the drugs, refused to do this research,&#xD;
             or who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yukio Nakamura</last_name>
    <phone>+81263372576</phone>
    <email>yxn14@aol.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yukio Nakamura</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>3908621</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yukio Nakamura, MD, PhD</last_name>
      <phone>+81-263-37-2659</phone>
      <email>yxn14@aol.jp</email>
    </contact>
    <investigator>
      <last_name>Yukio Nakamura, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shinshu University</investigator_affiliation>
    <investigator_full_name>Yukio Nakamura</investigator_full_name>
    <investigator_title>Lecturer at Shinshu University School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphosphonates</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/NCT03755193
org study id: DMAb switch 2018
nct id: NCT03755193
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the efficacy and adverse events in the following 3 groups
      in Japanese osteoporosis patients after 2-year-denosumab therapy:

      SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for
      24 months Eldecalcitol treatment for 24 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone
time frame: Change from Baseline Values of bone mineral density at 2 years in each group
arm group label: SERM plus ELD
arm group type: Active Comparator
description: To examine the effects of SERM plus ELD in osteoporosis patients
arm group label: BP plus ELD
arm group type: Active Comparator
description: To examine the effects of BP plus ELD in osteoporosis patients
arm group label: ELD alone
arm group type: Active Comparator
description: To examine the effects of ELD alone in osteoporosis patients
intervention type: Drug
intervention name: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"
description: To examine the effects of SERM and ELD in osteoporosis patients
arm group label: BP plus ELD
arm group label: ELD alone
arm group label: SERM plus ELD
intervention type: Drug
intervention name: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"
description: To examine the effects of BP and ELD in osteoporosis patients
arm group label: BP plus ELD
arm group label: ELD alone
arm group label: SERM plus ELD
intervention type: Drug
intervention name: ELD "Edirol®Tablet 0.75ug"
description: To examine the effects of ELD in osteoporosis patients
arm group label: BP plus ELD
arm group label: ELD alone
arm group label: SERM plus ELD
criteria: 
gender: All
minimum age: 20 Years
maximum age: 120 Years
healthy volunteers: No
last name: Yukio Nakamura
phone: +81263372576
email: yxn14@aol.jp
facility: 
status: Recruiting
contact: 
investigator: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Shinshu University
investigator full name: Yukio Nakamura
investigator title: Lecturer at Shinshu University School of Medicine
mesh term: Osteoporosis
mesh term: Diphosphonates
sharing ipd: No