Clinical trial NCT03437174: Burden of Illness in Hypoparathyroidism
Official title: Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism
Parathyroid Disease
Burden of Illness
SF-36
Quality of Life
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: University Medical Center Rostock
name: Praxis Endokrinologie in Charlottenburg, Berlin
name: Charite University, Berlin, Germany
name: Endocrine Practice, Oldenburg, Germany
First posted: 2018-02-19
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic hypo- and pseudohypoparathyroidism

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.

Eligibility criteria: 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

Primary outcomes:
measure: Burden of illness
timeFrame: 12 - 24 months
Secondary outcomes:
measure: Hypocalcemia
timeFrame: 12 - 24 months
measure: Psychological disorders
timeFrame: 12 - 24 months
measure: Subjective Health Status
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Endokrinologie in Charlottenburg
city: Berlin
country: Germany
facility: Charite Berlin
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Wuerzburg
country: Germany
facility: Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
Study officials:
affiliation: University Hospital Wuerzburg
name: Stefanie Hahner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arlt W, Fremerey C, Callies F, Reincke M, Schneider P, Timmermann W, Allolio B. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol. 2002 Feb;146(2):215-22. doi: 10.1530/eje.0.1460215.
citation: Hadker N, Egan J, Sanders J, Lagast H, Clarke BL. Understanding the burden of illness associated with hypoparathyroidism reported among patients in the PARADOX study. Endocr Pract. 2014 Jul;20(7):671-9. doi: 10.4158/EP13328.OR.