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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05585593
Other study ID # RESHOW
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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