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OpenTrials
Completed

NCT Number: NCT03437174

Burden of Illness in 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.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite Berlin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Burden of illness

    Time frame: 12 - 24 months

    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).

Secondary outcomes

  1. Hypocalcemia

    Time frame: 12 - 24 months

    documentation of frequency of hypocalcemia under standard treatment

  2. Psychological disorders

    Time frame: 12 - 24 months

    documentation of frequency of anxiety and depression under standard treatment

  3. Subjective Health Status

    Time frame: 12-24 months

    Assessment of the subjective health status due to chronic hypoparathyroidism by Assessment of subjective health status in patients with chronic hypoparathyroidism

Sponsors and collaborators

Lead sponsor

University of Wuerzburg

Other

Collaborators

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

Registry information

Official study title

Burden of Illness and Disease Associated Emergencies in Chronic Hypoparathyroidism

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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