Corticosteroid Rhythms in Hypoparathyroid Patients

NCT02986607 | Unknown Early Phase 1 DMC

• 1 other identifier: 2015/871
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoparathyroidism; Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Corticosteroid secretion in hypoparathyroid patients

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

  One week

Study Arms (1)

Hypoparathyroidism

EXPERIMENTAL

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

Interventions

parathyroid hormon 1-84 DRUG

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

Also known as: Natpara

Hypoparathyroidism

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 39167533 DERIVED

MeSH Terms

Conditions

Hypoparathyroidism; Hyperparathyroidism

Interventions

Parathyroid Hormone

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Eystein Husebye, Professor

  UiB

  STUDY CHAIR

Central Study Contacts

Marianne Astor, MD

CONTACT

40825265; marianne.astor@helse-bergen.no

Eystein Husebye, Professor

CONTACT

55973078; eyhu@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 8, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)