Registry for Hypoparathyroidism Wuerzburg
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Comorbidites [15 years]
Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment
- Subjective health status [15 years]
Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)
Secondary Outcome Measures
- Hypocalcemic and hypercalcemic events [15 years]
documentation of frequency of hypocalcemia under standard treatment
- Mortality [15 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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age of 18
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chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy
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written informed consent
Exclusion Criteria:
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age <18 years
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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
- Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.
- 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.
- 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.
- RESHOW