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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parathyroid hormon 1-84 | Drug | Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corticosteroid secretion in hypoparathyroid patients | Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianne Astor, MD | Contact | 40825265 | 0047 | marianne.astor@helse-bergen.no |
| Eystein Husebye, Professor | Contact | 55973078 | 0047 | eyhu@helse-bergen.no |
| Name | Affiliation | Role |
|---|---|---|
| Eystein Husebye, Professor | UiB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39167533 | Derived | 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. |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| D000602 | Amino Acids, Peptides, and Proteins |