Burden of Illness in Hypoparathyroidism

NCT03437174 | Completed

• 1 other identifier: BOHEME-HP
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypoparathyroidism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hypocalcemia

  12 - 24 months

• Psychological disorders

  12 - 24 months

• Subjective Health Status

  12-24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with chronic hypo- and pseudohypoparathyroidism

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wuerzburg: lead
• Ludwig-Maximilians - University of Munich: collaborator
• University Medical Center Rostock: collaborator
• Praxis Endokrinologie in Charlottenburg, Berlin: collaborator
• Charite University, Berlin, Germany: collaborator
• Endocrine Practice, Oldenburg, Germany: collaborator

Study Sites (5)

Endokrinologie in Charlottenburg

Berlin, D-10627, Germany

Location

Charite Berlin

Berlin, Germany

Location

Ludwig-Maximilians-Universität

Munich, 81377, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Würzburg, 97080, Germany

Location

Related 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. doi: 10.1530/eje.0.1460215.

  PMID: 11834431 BACKGROUND

• 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.

  PMID: 24449664 BACKGROUND

MeSH Terms

Conditions

Hypoparathyroidism; Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Stefanie Hahner, MD

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Stefanie Hahner

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 19, 2018
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

DE (5)