Burden of Illness in Hypoparathyroidism

Completed

• Conditions: Hypoparathyroidism

• Registration Number: NCT03437174
• Lead Sponsor: University of Wuerzburg

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 disease specific questionnaire, as well as the SF-36 are handed out.

Detailed Description

Design:

In a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the SF-36.

Patients:

Patients will be recruited out of the patient population of the participating five medical centers.

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 Timeline

• Study Start: 2015-08-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-10
• Last Update Submitted: 2018-02-10
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• chronic hypoparathyroidism (>12 months) under established therapy
• chronic pseudohypoparathyroidism (>12 months) under established therapy
• written informed consent

Exclusion Criteria

• age <18 years
• no detailed documentation of hypo- or pseudohypoparathyroidism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Burden of illness	12 - 24 months	Assessment of the burden of illness due to chronic hypoparathyroidism using a disease specific questionnaire to further investigate impairment in daily and professional life in comparison to the general German population (DEGS1, SHIP-2).

Secondary Outcome Measures

Name	Time	Method
Subjective Health Status	12-24 months	Assessment of the subjective health status due to chronic hypoparathyroidism by Assessment of subjective health status in patients with chronic hypoparathyroidism
Psychological disorders	12 - 24 months	documentation of frequency of anxiety and depression under standard treatment
Hypocalcemia	12 - 24 months	documentation of frequency of hypocalcemia under standard treatment

Trial Locations

Locations (5)

Charite Berlin; 🇩🇪 Berlin, Germany

Ludwig-Maximilians-Universität; 🇩🇪 Munich, Germany

Endokrinologie in Charlottenburg; 🇩🇪 Berlin, Germany

University Hospital Rostock; 🇩🇪 Rostock, Germany

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany