<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/NCT02218710</url>
  </required_header>
  <id_info>
    <org_study_id>S-20120156</org_study_id>
    <nct_id>NCT02218710</nct_id>
  </id_info>
  <brief_title>Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography</brief_title>
  <official_title>Bone Geometry, Volumetric Density, Microarchitecture and Estimated Bone Strength Assessed by High Resolution Peripheral Quantitative Computed Tomography in Patients With Adult Onset Growth Hormone Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess bone geometry, bone compartment specific volumetric&#xD;
      densities and micro-architecture as well as to evaluate non-invasive estimates of bone&#xD;
      strength in patients with adult onset growth hormone deficiency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>volumetric bone mineral density in grams per cc</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Adult Onset Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>Growth hormone deficiency</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are all seen at the Odense University Hospital at the department of Endocrinology.&#xD;
        All patients at the hypophysis clinic were checked and those receiving growth hormone&#xD;
        replacement therapy were invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women diagnosed with Adult onset Growth Hormone Deficiency&#xD;
&#xD;
          -  Age between 18-80&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Competing bone disease (e.g.. Mb. Paget, myelomatosis, osteogenesis imperfecta,&#xD;
             osteoporosis, primary hyperparathyroidism)&#xD;
&#xD;
          -  Ongoing medical treatment affecting bone metabolism (eg. osteoporosis medications)&#xD;
&#xD;
          -  Ongoing pregnancy or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristian Buch, Stud.med</last_name>
    <phone>+45 29434376</phone>
    <email>krbuc08@student.sdu.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Endocrinological department M, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Region syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <investigator>
      <last_name>Kim Brixen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marianne Andersen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dorthe Glintborg, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frantz Rom Poulsen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Claus Andersen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stinus Hansen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vikram Vinod Shanbhogue, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristian Buch</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne Andersen</investigator_full_name>
    <investigator_title>Associate Professor, DM, DMSc, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dwarfism, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_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/NCT02218710
org study id: S-20120156
nct id: NCT02218710
lead sponsor: 
has dmc: No
The aim of the study is to assess bone geometry, bone compartment specific volumetric
      densities and micro-architecture as well as to evaluate non-invasive estimates of bone
      strength in patients with adult onset growth hormone deficiency.
observational model: Case-Control
time perspective: Cross-Sectional
measure: volumetric bone mineral density in grams per cc
time frame: 1 year
arm group label: Growth hormone deficiency
arm group label: healthy controls
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kristian Buch, Stud.med
phone: +45 29434376
email: krbuc08@student.sdu.dk
facility: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Marianne Andersen
investigator title: Associate Professor, DM, DMSc, PhD
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases