<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/NCT03232476</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001094</org_study_id>
    <nct_id>NCT03232476</nct_id>
  </id_info>
  <brief_title>Effect of Mechanical Loading With PTH on Cortical Bone</brief_title>
  <official_title>Effect of Mechanical Loading With PTH on Cortical Bone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      Clinical trial to investigate effect of voluntary upper extremity loading in combination with&#xD;
      anabolic osteoporosis therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>radius bone mineral density</measure>
    <time_frame>12 month change</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>Loaded upper extremity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upper extremity voluntary loading</intervention_name>
    <description>Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.</description>
    <arm_group_label>Loaded upper extremity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 45+&#xD;
&#xD;
          -  postmenopausal&#xD;
&#xD;
          -  osteoporotic with high risk of fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no significant previous use of bone health modifying treatments&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joy Tsai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie David, BA</last_name>
    <phone>617-726-6129</phone>
    <email>ndavid2@mgh.harvard.edu</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Joy Tsai</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</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/NCT03232476
org study id: 2017P001094
nct id: NCT03232476
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical trial to investigate effect of voluntary upper extremity loading in combination with
      anabolic osteoporosis therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: radius bone mineral density
time frame: 12 month change
arm group label: Loaded upper extremity
arm group type: Other
description: This is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control.
intervention type: Device
intervention name: Upper extremity voluntary loading
description: Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.
arm group label: Loaded upper extremity
criteria: 
gender: Female
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joy Tsai, MD
role: Principal Investigator
affiliation: MGH
last name: Natalie David, BA
phone: 617-726-6129
email: ndavid2@mgh.harvard.edu
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Joy Tsai
investigator title: Principal Investigator
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal