Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-21 @ 5:32 AM
Study NCT ID:
NCT02005250
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steen.bonnema@rsyd.dk', 'phone': '+4527339180', 'title': 'Prof. Steen Bonnema', 'organization': 'Odense Universitetshospital, afd.M'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '19 month', 'description': 'Prospective monitoring and data collection of out-hospital patients during the study period', 'eventGroups': [{'id': 'EG000', 'title': 'Hyperthyroidism', 'description': "46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism", 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hypothyroidism', 'description': '27 women with overt or subclinical autoimmune hypothyroidism', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Thyroid Extreme CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyperthyroidism', 'description': "46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism"}, {'id': 'OG001', 'title': 'Hypothyroidism', 'description': '27 women with overt or subclinical autoimmune hypothyroidism'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.04'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '1.32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'one year', 'description': 'Bone cortical thickness in the radius measured by high-resolution peripheral quantitative CT, in newly diagnosed thyroid disorder, before and after treatment aimed to obtain euthyroidism', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyperthyroidism', 'description': "46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism"}, {'id': 'FG001', 'title': 'Hypothyroidism', 'description': '27 women with overt or subclinical autoimmune hypothyroidism'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Patients are enrolled consecutively, until maximum 200 participants are reached, or further enrollment is terminated on the decision by the sponsor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyperthyroidism', 'description': "46 women with Graves' disease, toxic nodular goiter or subclinical hyperthyroidism"}, {'id': 'BG001', 'title': 'Hypothyroidism', 'description': '27 women with overt or subclinical autoimmune hypothyroidism'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.83', 'spread': '11.47', 'groupId': 'BG000'}, {'value': '48.3', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '53', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cortical thickness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'groupId': 'BG000', 'lowerLimit': '0.61', 'upperLimit': '0.83'}, {'value': '1.15', 'groupId': 'BG001', 'lowerLimit': '1.01', 'upperLimit': '1.24'}, {'value': '0.90', 'groupId': 'BG002', 'lowerLimit': '0.61', 'upperLimit': '1.24'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2013-12-03', 'resultsFirstSubmitDate': '2020-03-06', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-09', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid Extreme CT', 'timeFrame': 'one year', 'description': 'Bone cortical thickness in the radius measured by high-resolution peripheral quantitative CT, in newly diagnosed thyroid disorder, before and after treatment aimed to obtain euthyroidism'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'hyperthyroidism', 'hypothyroidism'], 'conditions': ['Hyperthyroidism', 'Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '36064878', 'type': 'DERIVED', 'citation': 'Vinther CJ, Poulsen LH, Nicolaisen P, Obling ML, Brix TH, Hermann AP, Hegedus L, Jorgensen NR, Hansen S, Bonnema SJ. Do bone turnover markers reflect changes in bone microarchitecture during treatment of patients with thyroid dysfunction? J Endocrinol Invest. 2023 Feb;46(2):345-358. doi: 10.1007/s40618-022-01907-2. Epub 2022 Sep 5.'}, {'pmid': '33901280', 'type': 'DERIVED', 'citation': 'Larsen CB, Riis KR, Winther KH, Larsen EL, Ellervik C, Hegedus L, Brix TH, Poulsen HE, Bonnema SJ. Treatment of Hyperthyroidism Reduces Systemic Oxidative Stress, as Measured by Markers of RNA and DNA Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2512-e2520. doi: 10.1210/clinem/dgab273.'}]}, 'descriptionModule': {'briefSummary': 'The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder', 'detailedDescription': 'The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and one year after treatment for a thyroid functional disorder. Women with hyper- og hypothyroidism are included and undergo usual treatment. Patients are stratified into 10 different groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with untreated hyper- or hypothyroidism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ninformed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder,\n\nExclusion Criteria:\n\npregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, T-score below -3.5, thyroidea ophthalmopathy with indication for steroids,'}, 'identificationModule': {'nctId': 'NCT02005250', 'briefTitle': 'Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism', 'orgStudyIdInfo': {'id': 'Thyroid Xtreme'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hyperthyroidism', 'description': '61 pre- and postmenopausal women with hyperthyroidism'}, {'label': 'hypothyroidism', 'description': '32 pre- and postmenopausal women with hypothyroidism'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Steen Bonnema, phd, DMsci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steen Bonnema', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant, phd, DMsc', 'investigatorFullName': 'Steen Bonnema', 'investigatorAffiliation': 'Odense University Hospital'}}}}