Registry for Hypoparathyroidism Wuerzburg

Recruiting

• Conditions: Morality; Hypercalcemia; Comorbidities and Coexisting Conditions; Hypocalcemia; Quality of Life

• Registration Number: NCT05585593
• Lead Sponsor: University of Wuerzburg

Brief Summary

Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a standardized interview as well as blood sampling and examinations such as echocardiography and renal ultrasound are performed.

Detailed Description

Design:

In a longitudinal prospective trial the comorbidities, mortality, hypocalcemic and hypercalcemic events and quality of life in patients with chronic hypoparathyroidism will be evaluated by a standardized interview, blood sampling and further examinations such as echocardiography and renal ultrasound.

Patients:

Patients will be recruited out of the patient population of the University Hospital Wuerzburg.

Statistical Analysis:

Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.

Study Timeline

• Study Start: 2017-10-18
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-08
• Primary Completion: 2032-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age of 18
• chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy
• written informed consent

Exclusion Criteria

• age <18 years
• no detailed documentation of hypo- or pseudohypoparathyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comorbidites	15 years	Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment
Subjective health status	15 years	Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)

Secondary Outcome Measures

Name	Time	Method
Hypocalcemic and hypercalcemic events	15 years	documentation of frequency of hypocalcemia under standard treatment
Mortality	15 years

Trial Locations

Locations (1)

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Bavaria, Germany