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

NCT06419270 | Completed

• 1 other identifier: VK-1-10-72-169-23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are:

1. 1.Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls.
2. 2.Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls.
3. 3.Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls.

Conditions

Hypoparathyroidism; Cardiovascular Complication; Fractures, Bone; Renal Disease

Outcome Measures

Primary Outcomes (3)

• Arterial stiffness

  aortic pulse wave velocity in m/s

  24 months

• Vertebral fractures

  VFA assessing fractures in numbers

  24 months

• coronary artery plaque burden

  Heart CT scan assessing coronary artery calcium score

  24 months

Secondary Outcomes (3)

• Renal indices

  24 months

• bone indices

  24 months

• Cardiovascular indices

  24 months

Study Arms (2)

Patients

Patients with post-surgical hypoparathyroidism

Other: Observation

Controls

Gender and age matched controls from the general population

Other: Observation

Interventions

Observation OTHER

Observational

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from endocrine clinics Controls will be recruited from the general population

You may qualify if:

• 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
• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Gødstrup Hospital: collaborator

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus N, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and urine samples

MeSH Terms

Conditions

Hypoparathyroidism; Fractures, Bone; Kidney Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Wounds and Injuries; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Lars Rejnmark

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 17, 2024
• Study Start: May 26, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2024-09

Locations

DK (1)