ClinicalTrials.gg
RecruitingNCT05585593Updated Nov 8, 2022

Registry for Hypoparathyroidism Wuerzburg

An observational study in Comorbidities and Coexisting Conditions, Morality and Hypocalcemia, sponsored by University of Wuerzburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University of Wuerzburg · Observational

From the registry’s dates

  • Started Oct 2017; still recruiting 9 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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 standardized interview as well as blood sampling and examinations such as echocardiography and renal ultrasound are performed.

Read the detailed description

Design:

In a longitudinal prospective trial the comorbidities, mortality, hypocalcemic and hypercalcemic events and quality of life in patients with chronic hypoparathyroidism will be evaluated by a standardized interview, blood sampling and further examinations such as echocardiography and renal ultrasound.

Patients:

Patients will be recruited out of the patient population of the University Hospital Wuerzburg.

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.

02

Conditions studied

  • Comorbidities and Coexisting Conditions
  • Morality
  • Hypocalcemia
  • Hypercalcemia
  • Quality of Life
03

In context

Hypocalcemia

98 studies on the registry are indexed under Hypocalcemia; 16 are open to participants now.

This study's planned enrollment of 300 is above the median of 123 across 29 observational studies indexed under Hypocalcemia.

Browse Hypocalcemia studies →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Inclusion criteria

  • age of 18
  • chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy
  • written

Exclusion criteria

Exclusion Criteria:

  • age \<18 years
  • no detailed documentation of hypo- or pseudohypoparathyroidism
Terms in these criteria, in plain language(1)

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.

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Comorbidites

    Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment

    Time frame: 15 years

  2. Subjective health status

    Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)

    Time frame: 15 years

Secondary outcomes

  1. Hypocalcemic and hypercalcemic events

    documentation of frequency of hypocalcemia under standard treatment

    Time frame: 15 years

  2. Mortality

    Time frame: 15 years

07

Study locations

1 of 1 sites recruiting
  • Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
    Wuerzburg, Bavaria 97080, Germany
    Recruiting
08

References and documents

Publications

  • Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113. PubMed 32322899 ↗
  • Khan AA, AbuAlrob H, Punthakee Z, Shrayyef M, Werfalli RE, Kassem HA, Braga M, Millar A, Hussain S, Iqbal S, Khan T, Paul T, Van Uum S, Young JEM. Canadian national hypoparathyroidism registry: an overview of hypoparathyroidism in Canada. Endocrine. 2021 May;72(2):553-561. doi: 10.1007/s12020-021-02629-w. Epub 2021 Mar 2. PubMed 33655415 ↗
  • Underbjerg L, Sikjaer T, Mosekilde L, Rejnmark L. Cardiovascular and renal complications to postsurgical hypoparathyroidism: a Danish nationwide controlled historic follow-up study. J Bone Miner Res. 2013 Nov;28(11):2277-85. doi: 10.1002/jbmr.1979. PubMed 23661265 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Jan 2032, 170 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2022
First posted
Oct 19, 2022
StartActual
Oct 18, 2017
Primary completionEst.
Jan 1, 2032
CompletionEst.
Jan 1, 2032
Last update
Nov 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05585593
Lead sponsor
University of Wuerzburg
Responsible party
Stefanie Hahner (Prof. Dr., University of Wuerzburg) — Principal investigator
First posted
Oct 19, 2022
Start date
Oct 18, 2017
Primary completion
Jan 1, 2032 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Nov 8, 2022

Study contacts

Stefanie Hahner, MD
Contact
hahner_s@ukw.de
0931/201-39200

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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