Registry for Hypoparathyroidism Wuerzburg

• ClinicalTrials.gov Identifier: NCT05585593
• Recruitment Status: Recruiting
• First Posted: October 19, 2022
• Last Update Posted: November 8, 2022
• Sponsor: University of Wuerzburg
• Information provided by (Responsible Party): Stefanie Hahner, University of Wuerzburg

Tracking Information

• First Submitted Date: October 11, 2022
• First Posted Date: October 19, 2022
• Last Update Posted Date: November 8, 2022
• Actual Study Start Date: October 18, 2017
• Estimated Primary Completion Date: January 1, 2032 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2022)

• 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)

Original Primary Outcome Measures (submitted: October 17, 2022)

• 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 QoL questionnaires (e.g. SF-36, PHQ28)

Current Secondary Outcome Measures (submitted: October 17, 2022)

• Hypocalcemic and hypercalcemic events [ Time Frame: 15 years ]
  documentation of frequency of hypocalcemia under standard treatment
• Mortality [ Time Frame: 15 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry for Hypoparathyroidism Wuerzburg
• Official Title: Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg
• Brief 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Whole blood, serum, urine

• Sampling Method: Probability Sample
• Study Population: patients with chronic hypo- and pseudohypoparathyroidism

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 17, 2022): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2032
• Estimated Primary Completion Date: January 1, 2032 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• age <18 years
• no detailed documentation of hypo- or pseudohypoparathyroidism

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05585593
• Other Study ID Numbers: RESHOW
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Stefanie Hahner, University of Wuerzburg
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Wuerzburg
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Wuerzburg
• Verification Date: November 2022