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Corticosteroid Rhythms in Hypoparathyroid Patients

Primary Purpose

Hypoparathyroidism, Hyperparathyroidism

Status

Unknown status

Phase

Early Phase 1

Locations

Norway

Study Type

Interventional

Intervention

parathyroid hormon 1-84

About this trial

This is an interventional basic science trial for Hypoparathyroidism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypoparathyroidism

Arm 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.

Outcomes

Primary Outcome Measures

Corticosteroid secretion in hypoparathyroid patients

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02986607

First Posted

December 5, 2016

Last Updated

October 26, 2017

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02986607

Brief Title

Corticosteroid Rhythms in Hypoparathyroid Patients

Official Title

Corticosteroid Rhythms in Hypoparathyroid Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoparathyroidism, Hyperparathyroidism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypoparathyroidism

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

parathyroid hormon 1-84

Other Intervention Name(s)

Natpara

Intervention Description

Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.

Primary Outcome Measure Information:

Title

Corticosteroid secretion in hypoparathyroid patients

Description

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

Time Frame

One week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne Astor, MD

Phone

40825265

Ext

0047

marianne.astor@helse-bergen.no

First Name & Middle Initial & Last Name or Official Title & Degree

Eystein Husebye, Professor

Phone

55973078

Ext

0047

eyhu@helse-bergen.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eystein Husebye, Professor

Organizational Affiliation

UiB

Official's Role

Study Chair

Facility Information:

Facility Name

Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne Astor, MD

First Name & Middle Initial & Last Name & Degree

Hrafnkell Thordarson, MD

12. IPD Sharing Statement

Plan to Share IPD

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Corticosteroid Rhythms in Hypoparathyroid Patients

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