HypoparathyroidismCAREHYPONCT06419270
Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
An observational study of Hypoparathyroidism and Cardiovascular Complication, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are: 1. Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism, Cardiovascular Complication, Fractures, Bone
- What is being tested?
- Observation
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 26 May 2024to 30 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from endocrine clinics Controls will be recruited from the general population
Who may be able to join
- Patients only:
- Chronic post surgical hypoparathyroidism diagnosed > 5 years ago. (In case recruitment is too challenging, we will accept duration of disease of minimum one year. Including patients with longest duration of disease first.)
- Require treatment with active vitamin D ≥ 1 µg/day
- Controls only:
- No history of neck surgery
- No history of parathyroid disease
Show all 12Show fewer
- All participants:
- Age ≥ 18 years
- 25(OH)D vitamin ≥ 50 nmol/L
- Serum magnesium ≥ 0,50 mmol/L
- Able to read and understand Danish
- Willing and able to sign the informed consent form
Who cannot join
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
- Active cancer or former (except thyroid and basal cell skin) cancer treatment < 5 year ago
- Pregnancy, or breastfeeding < 1 year ago
- Untreated thyroid or liver diseases during the last year
- Treatment with lithium within the last 4 weeks
- Known allergy or sensitivity to iodine
- Any reason that in the opinion of the investigator, that would prevent the patient from completing the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine
Aarhus N, 8200
About this study
The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are:
- Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
- Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
- Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.
Read more
Results will be compared with gender and age matched controls from the general population.
Participants will have a CT scan, DXA scan, tonometry, blood samples and questionaries performed and collect a 24-hour urine sample.
Read the detailed description
Hypoparathyroidism is a rare endocrine disorder characterized by hypocalcemia with low or undetectable levels of parathyroid hormone. The most common cause of hypoparathyroidism is following neck surgery, whereas approximately 25% of hypoparathyroidism patients are suffering from non-surgical hypoparathyroidism due to e.g., genetic or autoimmune causes. According to updated international guidelines, the condition is considered chronic if treatment with calcium and activated vitamin D is still needed a year after surgery.
A large retrospective cohort study of patients with chronic hypoparathyroidism shows that patients with chronic hypoparathyroidism have a significantly higher risk of cardiovascular disease, compared to patients without hypoparathyroidism. Additionally, it is well known that patients with hypoparathyroidism are at increased risk of renal and extra-skeleton calcifications, although cardiovascular calcifications are only sparsely investigated. Furthermore, both higher arterial stiffness assessed by pulse wave velocity and an increased heart rate have previously been shown in patients with non-surgical hypoparathyroidism. It is largely unknown whether this also applies to patients with post-surgical hypoparathyroidism.
The overall aim of the project is to investigate cardiovascular, renal, and skeletal indices in patients diagnosed with Post Surgical hypoparathyroidism and test the following (null-)hypotheses:
- H0: Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
- H0: Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
- H0: Patients with post-surgical hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.
Patients and controls who accept participation will undergo a detailed examination in terms of: Medical history, physical examination, questionnaires, blood and 24-hour urine samples, DXA scan, HRpQCT, tonometry, 12-lead electrocardiogram, 24-hour blood pressure and a CT scan
Data are analyzed according to their distribution using parametric or non-parametric statistics. To address the hypotheses, statistical power calculations have been performed.
50 patients with post-surgical hypoparathyroidism will be matched on sex and age (± 2 years) with 50 randomly selected otherwise healthy controls from the general population.
- Being tested
- Observation
- Medical subject headings
- Hypoparathyroidism, Fractures, Bone, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with post-surgical hypoparathyroidism Receives: Other: Observation | |
| Controls | Gender and age matched controls from the general population Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
aortic pulse wave velocity in m/s
Measured: 24 months
Vertebral fractures
VFA assessing fractures in numbers
Measured: 24 months
coronary artery plaque burden
Heart CT scan assessing coronary artery calcium score
Measured: 24 months
Secondary outcomes (3)
Renal indices
Description of calcifications
Measured: 24 months
bone indices
Description of bone status
Measured: 24 months
Cardiovascular indices
Description of calcifications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start26 May 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Rejnmark, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419270
- Sponsor's protocol ID
- VK-1-10-72-169-23
- Acronym
- CAREHYPO
- Status last verified
- Sep 2024
- First submitted
- 7 May 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT06419270
- Acronym / sponsor ID
- CAREHYPO / VK-1-10-72-169-23
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gødstrup Hospital
- Study start
- 26 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 May 2024 (actual)
- 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 aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are:
- Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
- Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
- Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.
Results will be compared with gender and age matched controls from the general population.
Participants will have a CT scan, DXA scan, tonometry, blood samples and questionaries performed and collect a 24-hour urine sample.
Detailed description
Hypoparathyroidism is a rare endocrine disorder characterized by hypocalcemia with low or undetectable levels of parathyroid hormone. The most common cause of hypoparathyroidism is following neck surgery, whereas approximately 25% of hypoparathyroidism patients are suffering from non-surgical hypoparathyroidism due to e.g., genetic or autoimmune causes. According to updated international guidelines, the condition is considered chronic if treatment with calcium and activated vitamin D is still needed a year after surgery.
A large retrospective cohort study of patients with chronic hypoparathyroidism shows that patients with chronic hypoparathyroidism have a significantly higher risk of cardiovascular disease, compared to patients without hypoparathyroidism. Additionally, it is well known that patients with hypoparathyroidism are at increased risk of renal and extra-skeleton calcifications, although cardiovascular calcifications are only sparsely investigated. Furthermore, both higher arterial stiffness assessed by pulse wave velocity and an increased heart rate have previously been shown in patients with non-surgical hypoparathyroidism. It is largely unknown whether this also applies to patients with post-surgical hypoparathyroidism.
The overall aim of the project is to investigate cardiovascular, renal, and skeletal indices in patients diagnosed with Post Surgical hypoparathyroidism and test the following (null-)hypotheses:
- H0: Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
- H0: Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
- H0: Patients with post-surgical hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.
Patients and controls who accept participation will undergo a detailed examination in terms of: Medical history, physical examination, questionnaires, blood and 24-hour urine samples, DXA scan, HRpQCT, tonometry, 12-lead electrocardiogram, 24-hour blood pressure and a CT scan
Data are analyzed according to their distribution using parametric or non-parametric statistics. To address the hypotheses, statistical power calculations have been performed.
50 patients with post-surgical hypoparathyroidism will be matched on sex and age (± 2 years) with 50 randomly selected otherwise healthy controls from the general population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: ObservationPatients with post-surgical hypoparathyroidism |
| Controls | – | Other: ObservationGender and age matched controls from the general population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from endocrine clinics Controls will be recruited from the general population
Key inclusion criteria (12 listed)
- Chronic post surgical hypoparathyroidism diagnosed > 5 years ago. (In case recruitment is too challenging, we will accept duration of disease of minimum one year. Including patients with longest duration of disease first.)
- Require treatment with active vitamin D ≥ 1 µg/day
- No history of neck surgery
- No history of parathyroid disease
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m3
- Active cancer or former (except thyroid and basal cell skin) cancer treatment < 5 year ago
- Pregnancy, or breastfeeding < 1 year ago
- Untreated thyroid or liver diseases during the last year
- Treatment with lithium within the last 4 weeks
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 |
|---|---|---|
| ObservationObservational | Other | Controls, Patients |
Primary outcome
Arterial stiffness
Time frame: 24 months
aortic pulse wave velocity in m/s
Vertebral fractures
Time frame: 24 months
VFA assessing fractures in numbers
coronary artery plaque burden
Time frame: 24 months
Heart CT scan assessing coronary artery calcium score
3 secondary outcomes
Renal indices
Time frame: 24 months
bone indices
Time frame: 24 months
Cardiovascular indices
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Lars Rejnmark principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism and Cardiovascular Complication, run by University of Aarhus at 1 site in Denmark.
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 12 inclusion and 7 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: finished, as of the sponsor's last update on 5 Aug 2025. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2025.