NCT05585593

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2017Jan 2032

Study Start

First participant enrolled

October 18, 2017

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

14.2 years

First QC Date

October 11, 2022

Last Update Submit

November 2, 2022

Conditions

Comorbidities and Coexisting ConditionsMoralityHypocalcemiaHypercalcemiaQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Comorbidites

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

    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)

    15 years

Secondary Outcomes (2)

  • Hypocalcemic and hypercalcemic events

    15 years

  • Mortality

    15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with chronic hypo- and pseudohypoparathyroidism

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Related Publications (5)

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

    PMID: 32322899BACKGROUND

  • 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.

    PMID: 33655415BACKGROUND

  • 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.

    PMID: 23661265BACKGROUND

  • Fuss 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.

    PMID: 40172208DERIVED

  • Gronemeyer 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.

    PMID: 38027217DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, urine

MeSH Terms

Conditions

HypocalcemiaHypercalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Central Study Contacts

Stefanie Hahner, MD

CONTACT

0931/201-39200hahner_s@ukw.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 19, 2022

Study Start

October 18, 2017

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)