Corticosteroid Rhythms in Hypoparathyroid Patients

What Was Tested

This registered early phase 1 trial tested Parathyroid Hormone (PTH 1-84) for hyperparathyroidism.

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.

It had 1 arm (groups): Hypoparathyroidism (experimental).

The registry classes the interventions as drug.

More on the Plan

Visit 1: Optimizing conventional treatment regarding s-magnesium, s-calcium, s-phosphorous and 25-hydroxyvitamin D (25(OH)D)-levels.

Day 2: Start of PTH pump-treatment.

Day x: 24h microdialysis sampling and 24h urine-sampling and a venous blood sampling.

The Control patients (healthy volunteers and patients with hyperparathyroidism) will perform 24h microdialysis-sampling only.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male and female volunteers, aged 18-60 years.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients with diabetes mellitus, addison's disease and patients on steroid medication will not be included in this study.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Parathyroid Hormone (PTH 1-84) study: the hyperparathyroidism participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-03 with completion listed for 2018-01.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Corticosteroid secretion in hypoparathyroid patients (time frame: One week).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Parathyroid Hormone (PTH 1-84) in 30 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Parathyroid Hormone (PTH 1-84) compound page, Hyperparathyroidism research.