HypoparathyroidismEarly Phase 1NCT02986607
Corticosteroid Rhythms in Hypoparathyroid Patients
A Early Phase 1 study testing parathyroid hormon 1-84 in people with Hypoparathyroidism and Hyperparathyroidism, run by University of Bergen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism, Hyperparathyroidism
- What is being tested?
- parathyroid hormon 1-84
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Marianne Astor, MD
Hrafnkell Thordarson, MD
About this study
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.
Read the detailed 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.
- Conditions
- Hypoparathyroidism, Hyperparathyroidism
- Being tested
- parathyroid hormon 1-84
- Medical subject headings
- Hypoparathyroidism, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroid hormon 1-84Drug
Also called Natpara
Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: parathyroid hormon 1-84 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticosteroid secretion in hypoparathyroid patients
Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Marianne Astor, University of Bergen
- Investigators
- Eystein Husebye, Professor, Study chair, UiB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986607
- Sponsor's protocol ID
- 2015/871
- Status last verified
- Oct 2017
- First submitted
- 5 Dec 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39167533
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Rhythms in Hypoparathyroid Patients
- ClinicalTrials.gov ID
- NCT02986607
- Acronym / sponsor ID
- 2015/871
- Conditions
- Hypoparathyroidism, Hyperparathyroidism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoparathyroidism | Experimental | Drug: parathyroid hormon 1-84Subcutaneous 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroid hormon 1-84Also: NatparaHypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days. | Drug | Hypoparathyroidism |
Primary outcome
Corticosteroid secretion in hypoparathyroid patients
Time frame: One week
Evaluating of 24h corticosteroid secretion with PTH versus without PTH in hypoparathyroid patients with undetectable PTH-values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 39167533Astor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eystein Husebye, Professor study chair
UiB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing parathyroid hormon 1-84 in people with Hypoparathyroidism and Hyperparathyroidism, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Astor, MD (40825265 ext. 0047, marianne.astor@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticosteroid secretion in hypoparathyroid patients (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.