Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
Study NCT ID:
NCT04146259
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2019-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537525', 'term': 'Sclerosteosis'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002119', 'term': 'Calcium Carbonate'}, {'id': 'C008088', 'term': 'alfacalcidol'}], 'ancestors': [{'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in circulating serum sclerostin levels (pmol/L) during the observation period', 'timeFrame': '7 days', 'description': 'change in circulating serum sclerostin levels (pmol/L)during the observation period'}], 'secondaryOutcomes': [{'measure': 'the between groups difference in % changes of circulating sclerostin', 'timeFrame': '7 days', 'description': 'the between groups difference in % changes of circulating sclerostin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sclerostin', 'Hypoparathyroidism'], 'conditions': ['Hypoparathyroidism Postprocedural']}, 'descriptionModule': {'briefSummary': 'To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism', 'detailedDescription': 'Female patients with thyroid disorders, referred to the Department of Head and Neck Surgery, at Metaxa Anti-Cancer Hospital of Piraeus, for total thyroidectomy.\n\nBased on the development of biochemical hypocalcemia (cCa \\< 8.4 mg/dl), subjects were divided into 2 groups: Group A: without postsurgical hypoparathyroidism that served as controls and group B: subjects, with acute postsurgical hypoparathyroidism.\n\nBlood collections were performed in the morning after an overnight fast, in at least 3 different time points; preoperatively, 1st postoperative day and 7th postoperative day for the detrmination of sclerostin levels'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients with indication for total thyroidectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for total thyroidectomy\n\nExclusion Criteria:\n\n* parathyroid disorders, chronic kidney disease (eGFR\\< 60 ml/min), treatment with antiosteoporosis drugs, rheumatic disease and history of long term (\\>1 month) or current corticosteroid use'}, 'identificationModule': {'nctId': 'NCT04146259', 'briefTitle': 'Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'University of Athens'}, 'officialTitle': 'Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism', 'orgStudyIdInfo': {'id': '1387/08-12-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'Control'}, {'label': 'Group B', 'description': 'Post-surgical hypoparathyroidism', 'interventionNames': ['Drug: calcium carbonate and alphacalcidol']}], 'interventions': [{'name': 'calcium carbonate and alphacalcidol', 'type': 'DRUG', 'description': 'treatment for hypocalcemia', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14561', 'city': 'Athens', 'country': 'Greece', 'facility': 'Symeon Tournis', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Symeon tournis', 'investigatorAffiliation': 'University of Athens'}}}}