Registry for Hypoparathyroidism Wuerzburg

Quality of Life Clinical Trial

Official title:

Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585593
• Other study ID #: RESHOW
• Status: Recruiting
• Start date: October 18, 2017
• Est. completion date: January 1, 2032

Study information

• Verified date: November 2022
• Source: University of Wuerzburg
• Contact: Stefanie Hahner, MD
• Phone: 0931/201-39200
• Email: hahner_s[@]ukw.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• Hypercalcemia
• Hypocalcemia
• Hypoparathyroidism
• Morality
• Quality of Life

Locations

Country	Name	City	State
Germany	Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6). pii: dgaa113. doi: 10.1210/clinem/dgaa113. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comorbidites	Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment	15 years
Primary	Subjective health status	Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)	15 years
Secondary	Hypocalcemic and hypercalcemic events	documentation of frequency of hypocalcemia under standard treatment	15 years
Secondary	Mortality		15 years