<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/NCT01679080</url>
  </required_header>
  <id_info>
    <org_study_id>TreatOI</org_study_id>
    <nct_id>NCT01679080</nct_id>
  </id_info>
  <brief_title>The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta</brief_title>
  <official_title>The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are&#xD;
      fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the&#xD;
      present study is to investigate the effect of treatment of adult OI patients with&#xD;
      bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture&#xD;
      risk and quality of life.&#xD;
&#xD;
      The investigators will therefore conduct a double blind, placebo controlled trial, taking&#xD;
      genotype and previous antiresorptive therapy into account.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Eli Lilly has withdrawn support to the study of teriparatide and placebo pens. The study was&#xD;
    not able to continue as a randomized study without the supply of placebo pens.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Mineral Density (BMD)</measure>
    <time_frame>Three years</time_frame>
    <description>Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fracture risk</measure>
    <time_frame>Three years</time_frame>
    <description>Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Osteogenesis Imperfecta</condition>
  <arm_group>
    <arm_group_label>Zolendronic acid, 3 yr + placebo teriparatide, 2 yr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>yearly intravenous infusion of 5mg active zoledronic acid in 3 yr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>teriparatide 2 yr; active zol in 3rd yr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No active treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Observation in three years, no treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic acid</intervention_name>
    <description>antiresorptive and calcium and vitamin D</description>
    <arm_group_label>Zolendronic acid, 3 yr + placebo teriparatide, 2 yr</arm_group_label>
    <arm_group_label>teriparatide 2 yr; active zol in 3rd yr</arm_group_label>
    <other_name>zolendronate</other_name>
    <other_name>Aclasta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teriparatide</intervention_name>
    <description>anabolic and calcium and vitamin D</description>
    <arm_group_label>teriparatide 2 yr; active zol in 3rd yr</arm_group_label>
    <other_name>PTH</other_name>
    <other_name>Forsteo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No active treatment</intervention_name>
    <description>Calcium and vitamin D</description>
    <arm_group_label>No active treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of osteogenesis imperfecta&#xD;
&#xD;
          -  BMD&lt;-1.0 or&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  creatinine clearance &lt;30mL/min&#xD;
&#xD;
          -  treatment with glucocorticoids &gt; 5mg daily during the last 3 months&#xD;
&#xD;
          -  metabolic bone disease or vitamin d deficiency&#xD;
&#xD;
          -  liver or kidney disease&#xD;
&#xD;
          -  contradictions to zoledronic acid or teriparatide&#xD;
&#xD;
          -  increased baseline risk of osteosarcoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bente Langdahl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osteoporosis clinic; department of endocrinology and metabolism</name>
      <address>
        <city>Aarhus</city>
        <state>Aarhus C</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of endocrinology</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Endocrinology M</name>
      <address>
        <city>Odense</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <keyword>Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteogenesis Imperfecta</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zoledronic Acid</mesh_term>
    <mesh_term>Teriparatide</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/NCT01679080
org study id: TreatOI
nct id: NCT01679080
lead sponsor: 
has dmc: No
Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are
      fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the
      present study is to investigate the effect of treatment of adult OI patients with
      bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture
      risk and quality of life.

      The investigators will therefore conduct a double blind, placebo controlled trial, taking
      genotype and previous antiresorptive therapy into account.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone Mineral Density (BMD)
time frame: Three years
description: Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.
measure: Fracture risk
time frame: Three years
description: Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.
arm group label: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
arm group type: Experimental
description: yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
arm group label: teriparatide 2 yr; active zol in 3rd yr
arm group type: Experimental
description: daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
arm group label: No active treatment
arm group type: Placebo Comparator
description: Observation in three years, no treatment
intervention type: Drug
intervention name: Zoledronic acid
description: antiresorptive and calcium and vitamin D
arm group label: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
arm group label: teriparatide 2 yr; active zol in 3rd yr
other name: zolendronate
other name: Aclasta
intervention type: Drug
intervention name: Teriparatide
description: anabolic and calcium and vitamin D
arm group label: teriparatide 2 yr; active zol in 3rd yr
other name: PTH
other name: Forsteo
intervention type: Other
intervention name: No active treatment
description: Calcium and vitamin D
arm group label: No active treatment
criteria: 
gender: All
minimum age: 22 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bente Langdahl, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Osteogenesis Imperfecta
mesh term: Zoledronic Acid
mesh term: Teriparatide