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Corticosteroid Rhythms in Hypoparathyroid Patients

Sponsor
University of Bergen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02986607
Collaborator
Haukeland University Hospital (Other)
30
Enrollment
1
Location
1
Arm
27
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: parathyroid hormon 1-84
 Early Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Corticosteroid Rhythms in Hypoparathyroid Patients
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypoparathyroidism

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.

Drug: parathyroid hormon 1-84
Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.
Other Names:
  • Natpara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corticosteroid secretion in hypoparathyroid patients [One week]

      Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Postsurgical hypoparathyroidism of at least one year duration. Undetectable PTH values (< 0.3 pmol/l) or less than 1.3 pmol/l despite hypocalcaemia (Reference range PTH: 1.3-6.8 pmol/L) must be documented before inclusion. 25-hydroxyvitamin D (25(OH)D) should be > 50 nmol/l prior to baseline.

    • Healthy male and female volunteers, aged 18-60 years

    • Patients with primary hyperparathyroidism, defined as simultaneous increased PTH and serum calcium levels, normal or increased urine calcium to exclude hypocalciuric hypercalcemia, normal kidney function (estimated glomerular filtration rate (eGFR) above 60), aged 18-60 years

    Exclusion Criteria:

    • Patients with diabetes mellitus, Addison's disease and patients on steroid medication will not be included in this study.

    • Other exclusion criteria are unstable cardiovascular disease, active malignant disease, epilepsy, pregnancy or lactation, significant hepatic or kidney disease (alanine aminotransferase (ALAT) and or aspartate aminotransferase (ASAT) > 2 times upper limit of normal, eGFR < 30 ml/min), pharmacological treatment with PTH the last 3 months, treatment with other drugs that could interfere with interpretation of the results. Allergy to metacresol, lidocaine or multiple allergies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Norway 5021

    Sponsors and Collaborators

    • University of Bergen
    • Haukeland University Hospital

    Investigators

    • Study Chair: Eystein Husebye, Professor, UiB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne Astor, MD, University of Bergen
    ClinicalTrials.gov Identifier:
    NCT02986607
    Other Study ID Numbers:
    • 2015/871
    First Posted:
    Dec 8, 2016
    Last Update Posted:
    Oct 27, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hyperparathyroidism
    Hypoparathyroidism
    Parathyroid Hormone

    Study Results

    No Results Posted as of Oct 27, 2017