<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/NCT02986607</url>
  </required_header>
  <id_info>
    <org_study_id>2015/871</org_study_id>
    <nct_id>NCT02986607</nct_id>
  </id_info>
  <brief_title>Corticosteroid Rhythms in Hypoparathyroid Patients</brief_title>
  <official_title>Corticosteroid Rhythms in Hypoparathyroid Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bergen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal&#xD;
      activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the&#xD;
      renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality&#xD;
      of life. The main objective of the current study is to test if PTH deficiency influences the&#xD;
      secretion of corticosteroids and whether any abnormalities in the HPA-axis and the&#xD;
      RAAS-system can be reversed by PTH infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1: Optimizing conventional treatment regarding s-magnesium, s-calcium, s-phosphorous&#xD;
      and 25-hydroxyvitamin D (25(OH)D)-levels.&#xD;
&#xD;
      Visit 2 (In-hospital 4-7 days): Day one: 24h microdialysis sampling, venous blood sampling&#xD;
      and 24h urine will be collected. Day 2: Start of PTH pump-treatment. Day 3-x: dose adjustment&#xD;
      of PTH pump therapy according to Calcium Levels, the first two days after started PTH six&#xD;
      daily venous blood-samplings will be performed. Day x: 24h microdialysis sampling and 24h&#xD;
      urine-sampling and a venous blood sampling. Restart of conventional treatment.&#xD;
&#xD;
      The Control patients (healthy volunteers and patients with hyperparathyroidism) will perform&#xD;
      24h microdialysis-sampling only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Early Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corticosteroid secretion in hypoparathyroid patients</measure>
    <time_frame>One week</time_frame>
    <description>Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hypoparathyroidism</condition>
  <condition>Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Hypoparathyroidism</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous 24h microdialysis before PTH treatment and during continous subcutaneous PTH treatment. PTH, Natpara (parathyroid hormone 1-84) 50 µg doses with a concentration of 800 µg/ml, will be delivered by an insulin-pump (OmniPod) which delivers the infusion gear continous subcutaneously based on units (U) of insulin. 1 µg Natpara equals 0.125 U of infusion. The starting dose for pump treatment will be 0.50 µg per kilo per day and adjusted according to Calcium levels.&#xD;
Controls: patients With hyperparathyroidism and healthy volunteers will perform 24h microdialysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>parathyroid hormon 1-84</intervention_name>
    <description>Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.</description>
    <arm_group_label>Hypoparathyroidism</arm_group_label>
    <other_name>Natpara</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postsurgical hypoparathyroidism of at least one year duration. Undetectable PTH values&#xD;
             (&lt; 0.3 pmol/l) or less than 1.3 pmol/l despite hypocalcaemia (Reference range PTH:&#xD;
             1.3-6.8 pmol/L) must be documented before inclusion. 25-hydroxyvitamin D (25(OH)D)&#xD;
             should be &gt; 50 nmol/l prior to baseline.&#xD;
&#xD;
          -  Healthy male and female volunteers, aged 18-60 years&#xD;
&#xD;
          -  Patients with primary hyperparathyroidism, defined as simultaneous increased PTH and&#xD;
             serum calcium levels, normal or increased urine calcium to exclude hypocalciuric&#xD;
             hypercalcemia, normal kidney function (estimated glomerular filtration rate (eGFR)&#xD;
             above 60), aged 18-60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diabetes mellitus, Addison's disease and patients on steroid medication&#xD;
             will not be included in this study.&#xD;
&#xD;
          -  Other exclusion criteria are unstable cardiovascular disease, active malignant&#xD;
             disease, epilepsy, pregnancy or lactation, significant hepatic or kidney disease&#xD;
             (alanine aminotransferase (ALAT) and or aspartate aminotransferase (ASAT) &gt; 2 times&#xD;
             upper limit of normal, eGFR &lt; 30 ml/min), pharmacological treatment with PTH the last&#xD;
             3 months, treatment with other drugs that could interfere with interpretation of the&#xD;
             results. Allergy to metacresol, lidocaine or multiple allergies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eystein Husebye, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>UiB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianne Astor, MD</last_name>
    <phone>40825265</phone>
    <phone_ext>0047</phone_ext>
    <email>marianne.astor@helse-bergen.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eystein Husebye, Professor</last_name>
    <phone>55973078</phone>
    <phone_ext>0047</phone_ext>
    <email>eyhu@helse-bergen.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Astor, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Hrafnkell Thordarson, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>October 26, 2017</last_update_submitted>
  <last_update_submitted_qc>October 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Marianne Astor</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Hypoparathyroidism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parathyroid Hormone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986607
org study id: 2015/871
nct id: NCT02986607
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal
      activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the
      renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality
      of life. The main objective of the current study is to test if PTH deficiency influences the
      secretion of corticosteroids and whether any abnormalities in the HPA-axis and the
      RAAS-system can be reversed by PTH infusion.
Visit 1: Optimizing conventional treatment regarding s-magnesium, s-calcium, s-phosphorous
      and 25-hydroxyvitamin D (25(OH)D)-levels.

      Visit 2 (In-hospital 4-7 days): Day one: 24h microdialysis sampling, venous blood sampling
      and 24h urine will be collected. Day 2: Start of PTH pump-treatment. Day 3-x: dose adjustment
      of PTH pump therapy according to Calcium Levels, the first two days after started PTH six
      daily venous blood-samplings will be performed. Day x: 24h microdialysis sampling and 24h
      urine-sampling and a venous blood sampling. Restart of conventional treatment.

      The Control patients (healthy volunteers and patients with hyperparathyroidism) will perform
      24h microdialysis-sampling only.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Corticosteroid secretion in hypoparathyroid patients
time frame: One week
description: Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values
arm group label: Hypoparathyroidism
arm group type: Experimental
description: Subcutaneous 24h microdialysis before PTH treatment and during continous subcutaneous PTH treatment. PTH, Natpara (parathyroid hormone 1-84) 50 µg doses with a concentration of 800 µg/ml, will be delivered by an insulin-pump (OmniPod) which delivers the infusion gear continous subcutaneously based on units (U) of insulin. 1 µg Natpara equals 0.125 U of infusion. The starting dose for pump treatment will be 0.50 µg per kilo per day and adjusted according to Calcium levels.
Controls: patients With hyperparathyroidism and healthy volunteers will perform 24h microdialysis.
intervention type: Drug
intervention name: parathyroid hormon 1-84
description: Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.
arm group label: Hypoparathyroidism
other name: Natpara
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eystein Husebye, Professor
role: Study Chair
affiliation: UiB
last name: Marianne Astor, MD
phone: 40825265
phone ext: 0047
email: marianne.astor@helse-bergen.no
last name: Eystein Husebye, Professor
phone: 55973078
phone ext: 0047
email: eyhu@helse-bergen.no
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Marianne Astor
investigator title: MD
mesh term: Hyperparathyroidism
mesh term: Hypoparathyroidism
mesh term: Parathyroid Hormone
sharing ipd: No