Burden of Illness in Hypoparathyroidism

NCT ID: NCT03437174

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-01-01

Brief Summary

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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

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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.

Conditions

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Hypoparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

University Medical Center Rostock

OTHER

Sponsor Role collaborator

Praxis Endokrinologie in Charlottenburg, Berlin

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Endocrine Practice, Oldenburg, Germany

UNKNOWN

Sponsor Role collaborator

University of Wuerzburg

OTHER

Sponsor Role lead

Responsible Party

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Stefanie Hahner

Prof. Stefanie Hahner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefanie Hahner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Wuerzburg

Locations

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Endokrinologie in Charlottenburg

Berlin, , Germany

Site Status

Charite Berlin

Berlin, , Germany

Site Status

Ludwig-Maximilians-Universität

Munich, , Germany

Site Status

University Hospital Rostock

Rostock, , Germany

Site Status

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

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 11834431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24449664 (View on PubMed)

Other Identifiers

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BOHEME-HP

Identifier Type: -

Identifier Source: org_study_id

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