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

Fractures, Bone Clinical Trial

— CAREHYPO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419270
• Other study ID #: VK-1-10-72-169-23
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Sarah Thornhoj
• Phone: 40491821
• Email: sarthorn[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication
• Fractures, Bone
• Hypoparathyroidism
• Renal Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Gødstrup Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	aortic pulse wave velocity in m/s	24 months
Primary	Vertebral fractures	VFA assessing fractures in numbers	24 months
Primary	coronary artery plaque burden	Heart CT scan assessing coronary artery calcium score	24 months
Secondary	Renal indices	Description of calcifications	24 months
Secondary	bone indices	Description of bone status	24 months
Secondary	Cardiovascular indices	Description of calcifications	24 months