NCT06419270

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Observation	Observational

Timeline

• Start date: 2024-05-26
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-05-17
• Last updated: 2025-08-05

Locations

1 site across 1 country: Denmark