Comorbidities and Coexisting ConditionsNCT05585593
Registry for Hypoparathyroidism Wuerzburg
An observational study of Comorbidities and Coexisting Conditions and Morality, run by University of Wuerzburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Morality, Hypocalcemia
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2017to 1 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic hypo- and pseudohypoparathyroidism
Who may be able to join
- age of 18
- chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy
- written informed consent
Who cannot join
- age <18 years
- no detailed documentation of hypo- or pseudohypoparathyroidism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
Würzburg, Bavaria, 97080
Stefanie Hahner, MD, 0931/201-39200, hahner_s@ukw.de
About this study
Official title: Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
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.
- Conditions
- Comorbidities and Coexisting Conditions, Morality, Hypocalcemia, Hypercalcemia, Quality of Life
- Medical subject headings
- Hypocalcemia, Hypercalcemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comorbidites
Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment
Measured: 15 years
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)
Measured: 15 years
Secondary outcomes (2)
Hypocalcemic and hypercalcemic events
documentation of frequency of hypocalcemia under standard treatment
Measured: 15 years
Mortality
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start18 Oct 2017
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanie Hahner, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585593
- Sponsor's protocol ID
- RESHOW
- Status last verified
- Nov 2022
- First submitted
- 11 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.
PubMed 32322899Khan 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 33655415Underbjerg 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 23661265Fuss CT, Gronemeyer K, Hermes F, Dorr M, Schmid B, Morbach C, Schmidbauer L, Schlegel N, Fassnacht M, Koschker AC, Nordbeck P, Hannemann A, Hahner S. Cardiovascular status in chronic hypoparathyroidism: a systematic cross-sectional assessment in 168 patients. Eur J Endocrinol. 2025 Mar 27;192(4):373-384. doi: 10.1093/ejendo/lvaf023.
PubMed 40172208Gronemeyer K, Fuss CT, Hermes F, Plass A, Koschker AC, Hannemann A, Volzke H, Hahner S. Renal complications in chronic hypoparathyroidism - a systematic cross-sectional assessment. Front Endocrinol (Lausanne). 2023 Nov 2;14:1244647. doi: 10.3389/fendo.2023.1244647. eCollection 2023.
PubMed 38027217
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
- ClinicalTrials.gov ID
- NCT05585593
- Acronym / sponsor ID
- RESHOW
- Conditions
- Comorbidities and Coexisting Conditions, Morality, Hypocalcemia, Hypercalcemia, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic hypo- and pseudohypoparathyroidism
Key inclusion criteria (3 listed)
- age of 18
- chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy
- written informed consent
Key exclusion criteria (2 listed)
- age <18 years
- no detailed documentation of hypo- or pseudohypoparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comorbidites
Time frame: 15 years
Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment
Subjective health status
Time frame: 15 years
Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)
2 secondary outcomes
Hypocalcemic and hypercalcemic events
Time frame: 15 years
Mortality
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 32322899Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.
- Background: PubMed 33655415Khan 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.
- Background: PubMed 23661265Underbjerg 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.
- Derived from this study: PubMed 40172208Fuss CT, Gronemeyer K, Hermes F, Dorr M, Schmid B, Morbach C, Schmidbauer L, Schlegel N, Fassnacht M, Koschker AC, Nordbeck P, Hannemann A, Hahner S. Cardiovascular status in chronic hypoparathyroidism: a systematic cross-sectional assessment in 168 patients. Eur J Endocrinol. 2025 Mar 27;192(4):373-384. doi: 10.1093/ejendo/lvaf023.
- Derived from this study: PubMed 38027217Gronemeyer K, Fuss CT, Hermes F, Plass A, Koschker AC, Hannemann A, Volzke H, Hahner S. Renal complications in chronic hypoparathyroidism - a systematic cross-sectional assessment. Front Endocrinol (Lausanne). 2023 Nov 2;14:1244647. doi: 10.3389/fendo.2023.1244647. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Comorbidities and Coexisting Conditions
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2/3
Evaluating Smoking Cessation Interventions for PWH in South Africa
Smoking Cessation, HIV
RecruitingObservational study
Frailty in Outpatient Digestive Endoscopy
Frailty, Comorbidities and Coexisting Conditions
Recruiting
eCardiacRehab - a Hybrid Patient-Centered eHealth Programme
Comorbidities and Coexisting Conditions, Ethics
Active, not recruiting
Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity
Asthma Bronchiale, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidities and Coexisting Conditions and Morality, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Hahner, MD (0931/201-39200, hahner_s@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comorbidites (time frame: 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585593, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.