<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/NCT01687374</url>
  </required_header>
  <id_info>
    <org_study_id>HvH-2011-545-1</org_study_id>
    <nct_id>NCT01687374</nct_id>
  </id_info>
  <brief_title>Parathyroid Hormone for the Treatment of Humerus Fractures</brief_title>
  <official_title>Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      The investigators want to study whether parathyroid hormone improves healing of humerus after&#xD;
      a fracture. The investigators will assess healing of the humerus with Constant score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in constant score</measure>
    <time_frame>5, 8, 11, 23, and 104 weeks.</time_frame>
    <description>Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Oxford Shoulder Score</measure>
    <time_frame>5, 8, 11, 23, and 104 weeks.</time_frame>
    <description>Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bone formation evaluated by X-ray.</measure>
    <time_frame>5, 8, 11, 23, and 104 weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biochemical bone markers</measure>
    <time_frame>0, 5, 25 weeks</time_frame>
    <description>sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in regulatory T lymphocytes</measure>
    <time_frame>0, 8, 24 weeks</time_frame>
    <description>Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Shoulder Fractures</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Parathyroid hormone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1-84 parathyroid hormone</intervention_name>
    <description>100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.</description>
    <arm_group_label>Parathyroid hormone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline injection daily for 8 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  proximal humeral fracture eligible for conservative treatment.&#xD;
&#xD;
          -  able to understand the protocol&#xD;
&#xD;
          -  signs an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  kidney disease&#xD;
&#xD;
          -  severe osteoporosis&#xD;
&#xD;
          -  malignant disease&#xD;
&#xD;
          -  bone metabolic disease&#xD;
&#xD;
          -  oral treatment with bisphosphonates during the last 3 months.&#xD;
&#xD;
          -  treatment with Denosumab during the last 6 months.&#xD;
&#xD;
          -  intravenous treatment with bisphosphonates during the last 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lars Hyldstrup, MDSc</last_name>
    <email>hyld@dadlnet.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ulrich C Bang, M.D.</last_name>
    <email>ulrichbangbang@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lars Hyld, DMSc</last_name>
      <email>hyld@dadlnet.dk</email>
    </contact>
    <contact_backup>
      <last_name>Ulrich C Bang, M.D.</last_name>
      <email>ulrichbangbang@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ulrich C Bang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aage Vestergaard, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.</citation>
    <PMID>19594305</PMID>
  </reference>
  <reference>
    <citation>Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.</citation>
    <PMID>21915572</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>March 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Ulrich Bang</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>proximal humeral fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Shoulder Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</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/NCT01687374
org study id: HvH-2011-545-1
nct id: NCT01687374
lead sponsor: 
collaborator: 
has dmc: Yes
Hypothesis:

      The investigators want to study whether parathyroid hormone improves healing of humerus after
      a fracture. The investigators will assess healing of the humerus with Constant score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in constant score
time frame: 5, 8, 11, 23, and 104 weeks.
description: Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.
measure: Changes in Oxford Shoulder Score
time frame: 5, 8, 11, 23, and 104 weeks.
description: Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
measure: Changes in bone formation evaluated by X-ray.
time frame: 5, 8, 11, 23, and 104 weeks.
measure: Changes in biochemical bone markers
time frame: 0, 5, 25 weeks
description: sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
measure: Changes in regulatory T lymphocytes
time frame: 0, 8, 24 weeks
description: Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Parathyroid hormone
arm group type: Experimental
intervention type: Drug
intervention name: 1-84 parathyroid hormone
description: 100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
arm group label: Parathyroid hormone
intervention type: Drug
intervention name: Placebo
description: Saline injection daily for 8 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Lars Hyldstrup, MDSc
email: hyld@dadlnet.dk
last name: Ulrich C Bang, M.D.
email: ulrichbangbang@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Denmark
citation: Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
PMID: 19594305
citation: Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
PMID: 21915572
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Ulrich Bang
investigator title: Principal investigator
mesh term: Fractures, Bone
mesh term: Shoulder Fractures
mesh term: Hormones
mesh term: Parathyroid Hormone