<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/NCT03249012</url>
  </required_header>
  <id_info>
    <org_study_id>2018-3422</org_study_id>
    <nct_id>NCT03249012</nct_id>
  </id_info>
  <brief_title>Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism</brief_title>
  <official_title>Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to compare two different protocols commonly used in the management of post&#xD;
      thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The&#xD;
      investigators aim to compare the quality of life associated with these two protocols in a&#xD;
      randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrolled patients will be randomized in two treatment groups. In group 1, all patients will&#xD;
      receive calcium carbonate and calcitriol in the post-operative period, with standardized&#xD;
      weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if&#xD;
      their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if&#xD;
      post-operative PTH is inferior to 15.&#xD;
&#xD;
      The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess&#xD;
      quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and&#xD;
      adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
  <phase>N/A</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>Change from baseline quality of life at 1 and 4 weeks</measure>
    <time_frame>Pre-op, 1 week post-op and 4 weeks post-op</time_frame>
    <description>Short Form 36 (SF-36) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol</measure>
    <time_frame>1 week post-op, 4 weeks post-op</time_frame>
    <description>A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence and change in symptoms of hypocalcemia</measure>
    <time_frame>1 week post-op, 4 weeks post-op</time_frame>
    <description>A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hypoparathyroidism Postprocedural</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Empiric calcium and calcitriol repletion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients in this group will receive post-operative calcium carbonate and calcitriol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTH based repletion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Empiric use of Calcium Carbonate and Calcitriol</intervention_name>
    <description>Empiric calcium carbonate and calcitriol repletion</description>
    <arm_group_label>Empiric calcium and calcitriol repletion group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PTH based Calcium Carbonate and Calcitriol repletion</intervention_name>
    <description>PTH based treatment</description>
    <arm_group_label>PTH based repletion group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total thyroidectomy or completion hemithyroidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for neck dissection&#xD;
&#xD;
          -  Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder,&#xD;
             illiterate, does not speak French or English)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean-Philippe Vezina, MD, FRCSC</last_name>
    <phone>418-649-0252</phone>
    <email>jean-philippe.vezina@fmed.ulaval.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Quebec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1J1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Philippe Vezina, MD</last_name>
      <phone>418-649-0252</phone>
      <email>jean-philippe.vezina@fmed.ulaval.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
    <investigator_full_name>Jean-Philippe Vézina</investigator_full_name>
    <investigator_title>Otolaryngologist and Head &amp; Neck Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoparathyroidism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcitriol</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</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/NCT03249012
org study id: 2018-3422
nct id: NCT03249012
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare two different protocols commonly used in the management of post
      thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The
      investigators aim to compare the quality of life associated with these two protocols in a
      randomized trial.
Enrolled patients will be randomized in two treatment groups. In group 1, all patients will
      receive calcium carbonate and calcitriol in the post-operative period, with standardized
      weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if
      their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if
      post-operative PTH is inferior to 15.

      The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess
      quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and
      adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline quality of life at 1 and 4 weeks
time frame: Pre-op, 1 week post-op and 4 weeks post-op
description: Short Form 36 (SF-36) questionnaire
measure: Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
time frame: 1 week post-op, 4 weeks post-op
description: A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4
measure: Occurence and change in symptoms of hypocalcemia
time frame: 1 week post-op, 4 weeks post-op
description: A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.
arm group label: Empiric calcium and calcitriol repletion group
arm group type: Experimental
description: All patients in this group will receive post-operative calcium carbonate and calcitriol.
arm group label: PTH based repletion group
arm group type: Experimental
description: Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
intervention type: Other
intervention name: Empiric use of Calcium Carbonate and Calcitriol
description: Empiric calcium carbonate and calcitriol repletion
arm group label: Empiric calcium and calcitriol repletion group
intervention type: Other
intervention name: PTH based Calcium Carbonate and Calcitriol repletion
description: PTH based treatment
arm group label: PTH based repletion group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Philippe Vezina, MD, FRCSC
phone: 418-649-0252
email: jean-philippe.vezina@fmed.ulaval.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: CHU de Quebec-Universite Laval
investigator full name: Jean-Philippe Vézina
investigator title: Otolaryngologist and Head & Neck Surgeon
mesh term: Hypoparathyroidism
mesh term: Calcium, Dietary
mesh term: Calcitriol
mesh term: Calcium Carbonate
mesh term: Calcium