Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism

NCT ID: NCT06419270

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-26
• Study Completion Date: 2025-06-30

Brief 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. Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.

3. 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:

1. H0: Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.

2. H0: Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.

3. 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.

Conditions

Hypoparathyroidism; Cardiovascular Complication; Fractures, Bone; Renal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

Patients with post-surgical hypoparathyroidism

Observation

Intervention Type: OTHER

Observational

Controls

Gender and age matched controls from the general population

Observation

Intervention Type: OTHER

Observational

Interventions

Observation

Observational

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gødstrup Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Rejnmark

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Endocrinology and Internal Medicine

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

VK-1-10-72-169-23

Identifier Type: -

Identifier Source: org_study_id