Registry for Hypoparathyroidism Wuerzburg

Sponsor
University of Wuerzburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT05585593
Collaborator
(none)
300
1
170.4
1.8

Study Details

Study Description

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 W├╝rzburg, 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Registry and Biobank for Patients With Hypoparathyrodism Wuerzburg
Actual Study Start Date :
Oct 18, 2017
Anticipated Primary Completion Date :
Jan 1, 2032
Anticipated Study Completion Date :
Jan 1, 2032

Outcome Measures

Primary Outcome Measures

  1. Comorbidites [15 years]

    Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment

  2. Subjective health status [15 years]

    Assessment of the subjective health status by standardized QoL questionnaires (e.g. SF-36, PHQ28)

Secondary Outcome Measures

  1. Hypocalcemic and hypercalcemic events [15 years]

    documentation of frequency of hypocalcemia under standard treatment

  2. Mortality [15 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg Wuerzburg Bavaria Germany 97080

Sponsors and Collaborators

  • University of Wuerzburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stefanie Hahner, Prof. Dr., University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT05585593
Other Study ID Numbers:
  • RESHOW
First Posted:
Oct 19, 2022
Last Update Posted:
Oct 19, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2022