Corticosteroid Rhythms in Hypoparathyroid Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02986607
• Date of registration: 05/12/2016
• Prospective Registration: No
• Primary sponsor: University of Bergen
• Public title: Corticosteroid Rhythms in Hypoparathyroid Patients
• Scientific title: Corticosteroid Rhythms in Hypoparathyroid Patients
• Date of first enrolment: March 2016
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02986607
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

Norway

Contacts

• Name: Marianne Astor, MD

• Name: Marianne Astor, MD

• Name: Eystein Husebye, Professor
• Affiliation: UiB

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyperparathyroidism

Hypoparathyroidism

Intervention(s)

Drug: parathyroid hormon 1-84

Primary Outcome(s)

Corticosteroid secretion in hypoparathyroid patients [Time Frame: One week]

Secondary ID(s)

2015/871

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Haukeland University Hospital