<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/NCT01734824</url>
  </required_header>
  <id_info>
    <org_study_id>Vinforce-012</org_study_id>
    <secondary_id>Bone marrow edema</secondary_id>
    <nct_id>NCT01734824</nct_id>
  </id_info>
  <brief_title>Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo</brief_title>
  <official_title>Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The etiology of bone marrow edema (BME) is still uncertain. Several studies report&#xD;
      therapeutic success with antiresorptive drugs.&#xD;
&#xD;
      This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily&#xD;
      teriparatide sc for three months or placebo.&#xD;
&#xD;
      MRI examinations at baseline and after three months will be performed. Serum bone turnover&#xD;
      markers will be evaluated as well as QoL questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    no patients randomized&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 4</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>Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs</measure>
    <time_frame>baseline - month 1 - month 3</time_frame>
    <description>MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Bone Marrow Oedema Syndrome</condition>
  <condition>High Turnover Bone Disease</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Teriparatide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>daily subcutaneous injection of teriparatide 20µg for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Teriparatide</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>daily subcutaneous teriparatide placebo injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Denosumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one subcutaneous injection of denosumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Denosumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one subcutaneous injection of denosumab placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Denosumab</intervention_name>
    <description>sc RANKL-inhibitor</description>
    <arm_group_label>Denosumab</arm_group_label>
    <other_name>Prolia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide</intervention_name>
    <description>daily subcutaneous injection of teriparatide</description>
    <arm_group_label>Teriparatide</arm_group_label>
    <other_name>PTH 1-34</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Denosumab</intervention_name>
    <description>one subcutaneous injection denosumab placebo</description>
    <arm_group_label>Placebo Denosumab</arm_group_label>
    <other_name>Prolia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Teriparatide</intervention_name>
    <description>daily subcutaneous placebo injection</description>
    <arm_group_label>Placebo Teriparatide</arm_group_label>
    <other_name>PTH 1-34</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MRI diagnosed bone marrow edema&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any prior antiresorptive or osteoanabolic treatment&#xD;
&#xD;
          -  any prior therapy with strontium ranelate&#xD;
&#xD;
          -  Hyper-/hypocalcemia&#xD;
&#xD;
          -  malignancies&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  and contraindication against denosumab or teriparatide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Muschitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University Vienna - St. Vincent Hospital</name>
      <address>
        <city>Vienna</city>
        <zip>1060</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://www.vinforce.at</url>
    <description>non-profit web page</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>June 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Christian Muschitz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bone marrow edema, denosumab, PTH 1-84</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Denosumab</mesh_term>
    <mesh_term>Teriparatide</mesh_term>
    <mesh_term>Parathyroid Hormone</mesh_term>
  </intervention_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/NCT01734824
org study id: Vinforce-012
secondary id: Bone marrow edema
nct id: NCT01734824
lead sponsor: 
has dmc: Yes
The etiology of bone marrow edema (BME) is still uncertain. Several studies report
      therapeutic success with antiresorptive drugs.

      This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME
Patients are assigned to receive either denosumab 60mg sc (once) or placebo or daily
      teriparatide sc for three months or placebo.

      MRI examinations at baseline and after three months will be performed. Serum bone turnover
      markers will be evaluated as well as QoL questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Reduction/termination of bone marrow edema with antiresorptive and osteoanabolic drugs
time frame: baseline - month 1 - month 3
description: MRI examination, fasting serum levels of bone turnover markers, QoL-questionnaire, VAS score
arm group label: Teriparatide
arm group type: Active Comparator
description: daily subcutaneous injection of teriparatide 20µg for three months
arm group label: Placebo Teriparatide
arm group type: Placebo Comparator
description: daily subcutaneous teriparatide placebo injection
arm group label: Denosumab
arm group type: Active Comparator
description: one subcutaneous injection of denosumab
arm group label: Placebo Denosumab
arm group type: Active Comparator
description: one subcutaneous injection of denosumab placebo
intervention type: Drug
intervention name: Denosumab
description: sc RANKL-inhibitor
arm group label: Denosumab
other name: Prolia
intervention type: Drug
intervention name: Teriparatide
description: daily subcutaneous injection of teriparatide
arm group label: Teriparatide
other name: PTH 1-34
intervention type: Drug
intervention name: Placebo Denosumab
description: one subcutaneous injection denosumab placebo
arm group label: Placebo Denosumab
other name: Prolia
intervention type: Drug
intervention name: Placebo Teriparatide
description: daily subcutaneous placebo injection
arm group label: Placebo Teriparatide
other name: PTH 1-34
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Christian Muschitz, MD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
url: http://www.vinforce.at
description: non-profit web page
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Christian Muschitz
investigator title: Principal Investigator
mesh term: Bone Diseases
mesh term: Edema
mesh term: Denosumab
mesh term: Teriparatide
mesh term: Parathyroid Hormone