An observational study in Hypoparathyroidism, sponsored by University of Wuerzburg. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by University of Wuerzburg · Observational
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.
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.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's enrollment of 205 is above the median of 147 across 48 observational studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →University of Wuerzburg is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with chronic hypo- and pseudohypoparathyroidism
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: 12 - 24 months
Hypocalcemia
documentation of frequency of hypocalcemia under standard treatment
Time frame: 12 - 24 months
Psychological disorders
documentation of frequency of anxiety and depression under standard treatment
Time frame: 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
Time frame: 12-24 months
Ran from Aug 2015 to primary completion in Dec 2017, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University of Wuerzburg