Corticosteroid Rhythms in Hypoparathyroid Patients

NCT ID: NCT02986607

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-06-30

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.

Conditions

Hypoparathyroidism; Hyperparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

parathyroid hormon 1-84

Intervention Type: DRUG

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

Interventions

parathyroid hormon 1-84

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

Intervention Type: DRUG

Other Intervention Names

Natpara

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Marianne Astor

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eystein Husebye, Professor

Role: STUDY_CHAIR

UiB

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Marianne Astor, MD

Role: CONTACT

Phone: 40825265

Email: marianne.astor@helse-bergen.no

Eystein Husebye, Professor

Role: CONTACT

Phone: 55973078

Email: eyhu@helse-bergen.no

Facility Contacts

Marianne Astor, MD

Role: primary

Hrafnkell Thordarson, MD

Role: backup

References

Astor MC, Lovas K, Methlie P, Simunkova K, Assmus J, Husebye ES. Corticosteroid rhythms in hypoparathyroid patients. Eur J Endocrinol. 2024 Aug 30;191(3):271-278. doi: 10.1093/ejendo/lvae102.

Reference Type: DERIVED

PMID: 39167533 (View on PubMed)

Other Identifiers

2015/871

Identifier Type: -

Identifier Source: org_study_id