Clinical trial NCT05585593: Registry for Hypoparathyroidism Wuerzburg
Official title: Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Comorbidities and Coexisting Conditions
Morality
Hypocalcemia
Hypercalcemia
Quality of Life
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic hypo- and pseudohypoparathyroidism

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comorbidites
timeFrame: 15 years
measure: Subjective health status
timeFrame: 15 years
Secondary outcomes:
measure: Hypocalcemic and hypercalcemic events
timeFrame: 15 years
measure: Mortality
timeFrame: 15 years
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
state: Bavaria
Study officials:
References:
citation: Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.
citation: Khan AA, AbuAlrob H, Punthakee Z, Shrayyef M, Werfalli RE, Kassem HA, Braga M, Millar A, Hussain S, Iqbal S, Khan T, Paul T, Van Uum S, Young JEM. Canadian national hypoparathyroidism registry: an overview of hypoparathyroidism in Canada. Endocrine. 2021 May;72(2):553-561. doi: 10.1007/s12020-021-02629-w. Epub 2021 Mar 2.
citation: Underbjerg L, Sikjaer T, Mosekilde L, Rejnmark L. Cardiovascular and renal complications to postsurgical hypoparathyroidism: a Danish nationwide controlled historic follow-up study. J Bone Miner Res. 2013 Nov;28(11):2277-85. doi: 10.1002/jbmr.1979.