Burden of Illness in Hypoparathyroidism

Hypoparathyroidism Clinical Trial

Official title:

Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437174
• Other study ID #: BOHEME-HP
• Status: Completed
• Phase: N/A
• First received: February 10, 2018
• Last updated: February 10, 2018
• Start date: August 1, 2015
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2018
• Source: University of Wuerzburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: January 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism

Locations

Country	Name	City	State
Germany	Charite Berlin	Berlin
Germany	Endokrinologie in Charlottenburg	Berlin
Germany	Ludwig-Maximilians-Universität	Munich
Germany	University Hospital Rostock	Rostock
Germany	Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg	Wuerzburg

Sponsors (6)

Lead Sponsor	Collaborator
University of Wuerzburg	Charite University, Berlin, Germany, Endocrine Practice, Oldenburg, Germany, Ludwig-Maximilians - University of Munich, Praxis Endokrinologie in Charlottenburg, Berlin, University Medical Center Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burden of illness	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).	12 - 24 months
Secondary	Hypocalcemia	documentation of frequency of hypocalcemia under standard treatment	12 - 24 months
Secondary	Psychological disorders	documentation of frequency of anxiety and depression under standard treatment	12 - 24 months
Secondary	Subjective Health Status	Assessment of the subjective health status due to chronic hypoparathyroidism by Assessment of subjective health status in patients with chronic hypoparathyroidism	12-24 months