Burden of Illness in Hypoparathyroidism

Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03437174

Enrollment

205

Registered

2018-02-19

Start date

2015-08-01

Completion date

2018-01-01

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoparathyroidism

Keywords

Hypoparathyroidism, Parathyroid Disease, Burden of Illness, SF-36, Quality of Life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Hypocalcemia	12 - 24 months	documentation of frequency of hypocalcemia under standard treatment
Psychological disorders	12 - 24 months	documentation of frequency of anxiety and depression under standard treatment
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

Countries

Germany

Outcome results