Burden of Illness in Hypoparathyroidism

Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism

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.

Study Overview

• Status: Completed
• Conditions: Hypoparathyroidism

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 Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Berlin
  • Berlin, Germany, D-10627
    • Endokrinologie in Charlottenburg
  • Munich, Germany, 81377
    • Ludwig-Maximilians-Universität
  • Rostock, Germany, 18057
    • University Hospital Rostock
  • Wuerzburg, Germany, 97080
    • Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with chronic hypo- and pseudohypoparathyroidism

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wuerzburg
• Collaborators: Charite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; University Medical Center Rostock; Praxis Endokrinologie in Charlottenburg, Berlin; Endocrine Practice, Oldenburg, Germany
• Investigators: Principal Investigator: Stefanie Hahner, MD, University Hospital Wuerzburg

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 10, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; SF-36; Hypoparathyroidism; Parathyroid Disease; Burden of Illness
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: BOHEME-HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No