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NCT Number: NCT05585593

Registry for Hypoparathyroidism Wuerzburg

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.

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Key information

Conditions

Comorbidities and Coexisting Conditions Calcium Metabolism Disorders Hypercalcemia Hypocalcemia Metabolic Diseases Morality Nutritional and Metabolic Diseases Quality of Life Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Würzburg, Bavaria, 97080, Germany

Location status: Recruiting

Location contact

Stefanie Hahner, MD

CONTACT

[email protected]

0931/201-39200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Hypocalcemic and hypercalcemic events

    Time frame: 15 years

    documentation of frequency of hypocalcemia under standard treatment

  2. Mortality

    Time frame: 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Stefanie Hahner, MD

CONTACT

[email protected]

0931/201-39200

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Registry information

Official study title

Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg

Important dates

Study start
2017
Primary completion
2032
Study completion
2032
First posted
Oct 19, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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