Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Subjective health status
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Subjective health status
Time Frame: 15 years
Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)
Comorbidites
Time Frame: 15 years
Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment
Secondary Outcomes
- Hypocalcemic and hypercalcemic events(15 years)
- Mortality(15 years)
Investigators
Stefanie Hahner
Prof. Dr.
University of Wuerzburg