Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT05585593
Status:
RECRUITING
Last Update Posted:
2022-11-08
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry for Hypoparathyroidism Wuerzburg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006996', 'term': 'Hypocalcemia'}, {'id': 'D006934', 'term': 'Hypercalcemia'}], 'ancestors': [{'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comorbidites', 'timeFrame': '15 years', 'description': 'Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment'}, {'measure': 'Subjective health status', 'timeFrame': '15 years', 'description': 'Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28)'}], 'secondaryOutcomes': [{'measure': 'Hypocalcemic and hypercalcemic events', 'timeFrame': '15 years', 'description': 'documentation of frequency of hypocalcemia under standard treatment'}, {'measure': 'Mortality', 'timeFrame': '15 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Comorbidities and Coexisting Conditions', 'Morality', 'Hypocalcemia', 'Hypercalcemia', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '32322899', 'type': 'BACKGROUND', 'citation': 'Bilezikian JP. Hypoparathyroidism. J Clin Endocrinol Metab. 2020 Jun 1;105(6):1722-36. doi: 10.1210/clinem/dgaa113.'}, {'pmid': '33655415', 'type': 'BACKGROUND', 'citation': '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': '23661265', 'type': 'BACKGROUND', 'citation': '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': '40172208', 'type': 'DERIVED', 'citation': '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': '38027217', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design:\n\nIn 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.\n\nPatients:\n\nPatients will be recruited out of the patient population of the University Hospital Wuerzburg.\n\nStatistical Analysis:\n\nDocumentation 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic hypo- and pseudohypoparathyroidism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 18\n* chronic hypoparathyroidism (\\>12 months) under established therapy or chronic pseudohypoparathyroidism (\\>12 months) under established therapy\n* written informed consent\n\nExclusion Criteria:\n\n* age \\<18 years\n* no detailed documentation of hypo- or pseudohypoparathyroidism'}, 'identificationModule': {'nctId': 'NCT05585593', 'briefTitle': 'Registry for Hypoparathyroidism Wuerzburg', 'organization': {'class': 'OTHER', 'fullName': 'University of Wuerzburg'}, 'officialTitle': 'Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg', 'orgStudyIdInfo': {'id': 'RESHOW'}}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefanie Hahner, MD', 'role': 'CONTACT', 'email': 'hahner_s@ukw.de', 'phone': '0931/201-39200'}], 'facility': 'Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'centralContacts': [{'name': 'Stefanie Hahner, MD', 'role': 'CONTACT', 'email': 'hahner_s@ukw.de', 'phone': '0931/201-39200'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wuerzburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Stefanie Hahner', 'investigatorAffiliation': 'University of Wuerzburg'}}}}