Registry for Hypoparathyroidism Wuerzburg

NCT ID: NCT05585593

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-18

Study Completion Date

2032-01-01

Brief Summary

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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

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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.

Conditions

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Comorbidities and Coexisting Conditions Morality Hypocalcemia Hypercalcemia Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role lead

Responsible Party

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Stefanie Hahner

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Würzburg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefanie Hahner, MD

Role: CONTACT

0931/201-39200

Facility Contacts

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Stefanie Hahner, MD

Role: primary

0931/201-39200

References

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Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.

Reference Type BACKGROUND
PMID: 32322899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33655415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23661265 (View on PubMed)

Fuss CT, Gronemeyer K, Hermes F, Dorr M, Schmid B, Morbach C, Schmidbauer L, Schlegel N, Fassnacht M, Koschker AC, Nordbeck P, Hannemann A, Hahner S. Cardiovascular status in chronic hypoparathyroidism: a systematic cross-sectional assessment in 168 patients. Eur J Endocrinol. 2025 Mar 27;192(4):373-384. doi: 10.1093/ejendo/lvaf023.

Reference Type DERIVED
PMID: 40172208 (View on PubMed)

Gronemeyer K, Fuss CT, Hermes F, Plass A, Koschker AC, Hannemann A, Volzke H, Hahner S. Renal complications in chronic hypoparathyroidism - a systematic cross-sectional assessment. Front Endocrinol (Lausanne). 2023 Nov 2;14:1244647. doi: 10.3389/fendo.2023.1244647. eCollection 2023.

Reference Type DERIVED
PMID: 38027217 (View on PubMed)

Other Identifiers

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RESHOW

Identifier Type: -

Identifier Source: org_study_id

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