Corticosteroid Rhythms in Hypoparathyroid Patients

Hyperparathyroidism Clinical Trial

Official title:

Corticosteroid Rhythms in Hypoparathyroid Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986607
• Other study ID #: 2015/871
• Status: Recruiting
• Phase: Early Phase 1
• First received: December 5, 2016
• Last updated: October 26, 2017
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2017
• Source: University of Bergen
• Contact: Marianne Astor, MD
• Phone: 40825265
• Email: marianne.astor[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hypoparathyroidism

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corticosteroid secretion in hypoparathyroid patients	Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values	One week