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Registry for Hypoparathyroidism Wuerzburg

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ClinicalTrials.gov Identifier: NCT05585593
Recruitment Status : Recruiting
First Posted : October 19, 2022
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Stefanie Hahner, University of Wuerzburg

Study Description
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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
Comorbidities and Coexisting Conditions Morality Hypocalcemia Hypercalcemia Quality of Life

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
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : January 1, 2032
Estimated Study Completion Date : January 1, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Comorbidites [ Time Frame: 15 years ]
    Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment

  2. Subjective health status [ Time Frame: 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 :
  1. Hypocalcemic and hypercalcemic events [ Time Frame: 15 years ]
    documentation of frequency of hypocalcemia under standard treatment

  2. Mortality [ Time Frame: 15 years ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum, urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with chronic hypo- and pseudohypoparathyroidism
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05585593


Contacts
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Contact: Stefanie Hahner, MD 0931/201-39200 hahner_s@ukw.de

Locations
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Germany
Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Stefanie Hahner, MD    0931/201-39200    hahner_s@ukw.de   
Sponsors and Collaborators
University of Wuerzburg
More Information
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Publications:

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Responsible Party: Stefanie Hahner, Prof. Dr., University of Wuerzburg
ClinicalTrials.gov Identifier: NCT05585593    
Other Study ID Numbers: RESHOW
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypocalcemia
Hypercalcemia
Hypoparathyroidism
Parathyroid Diseases
 Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance