Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02304757
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013667', 'term': 'Technetium'}, {'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004603', 'term': 'Elements, Radioactive'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D011868', 'term': 'Radioisotopes'}, {'id': 'D007554', 'term': 'Isotopes'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mc_7419@hotmail.com', 'phone': '02125078593', 'title': 'Chao Ma', 'phoneExt': '86', 'organization': "Tenth People's Hospital of Tongji University"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected at 1year.', 'eventGroups': [{'id': 'EG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 6, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'upper gastrointestinal (GI) adverse events', 'notes': 'In the 6/72 patients with GI adverse events treated with alendronate, 2 cases had abdominal pain, 4 had dyspepsia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 72, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change of Bone Mineral Density in Lumbar and Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'OG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}], 'classes': [{'title': 'Percentage change of lumbar spine at month 6', 'categories': [{'measurements': [{'value': '3.0', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Percentage change of lumbar spine month 12', 'categories': [{'measurements': [{'value': '3.8', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Percentage change of total hip at month 6', 'categories': [{'measurements': [{'value': '0.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Percentage change of total hip at month 12', 'categories': [{'measurements': [{'value': '5.1', 'spread': '17', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months, and 12 months', 'description': 'Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Turnover Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'OG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}], 'classes': [{'title': 'PINP before treatment', 'categories': [{'measurements': [{'value': '43.7725', 'spread': '14.74802', 'groupId': 'OG000'}, {'value': '29.255', 'spread': '29.46603', 'groupId': 'OG001'}]}]}, {'title': 'PINP at 12months', 'categories': [{'measurements': [{'value': '52.6422', 'spread': '20.56123', 'groupId': 'OG000'}, {'value': '20.56123', 'spread': '25.34437', 'groupId': 'OG001'}]}]}, {'title': 'CTX before treatment', 'categories': [{'measurements': [{'value': '0.4657', 'spread': '0.25277', 'groupId': 'OG000'}, {'value': '0.1526', 'spread': '0.14138', 'groupId': 'OG001'}]}]}, {'title': 'CTX at 12months', 'categories': [{'measurements': [{'value': '0.3707', 'spread': '0.21062', 'groupId': 'OG000'}, {'value': '0.1771', 'spread': '0.16019', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 months', 'description': 'bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'OG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}], 'classes': [{'title': 'Physical component summary at baseline by 36-item Short Form Health Status Survey questionnaire', 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '92.5'}, {'value': '64.4', 'groupId': 'OG001', 'lowerLimit': '30.5', 'upperLimit': '87.5'}]}]}, {'title': 'Physical component summary at 6months by 36-item Short Form Health Status Survey questionnaire', 'categories': [{'measurements': [{'value': '67.587', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '100'}, {'value': '69.09', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '94.25'}]}]}, {'title': 'Physical component summary at 12months by 36-item Short Form Health Status Survey questionnaire', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '30.25', 'upperLimit': '94.25'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '92.25'}]}]}, {'title': 'Mental component score at baseline by 36-item Short Form Health Status Survey questionnaire', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000', 'lowerLimit': '19.38', 'upperLimit': '100'}, {'value': '65.7', 'groupId': 'OG001', 'lowerLimit': '34.88', 'upperLimit': '95.88'}]}]}, {'title': 'Mental component score at 6months by 36-item Short Form Health Status Survey questionnaire', 'categories': [{'measurements': [{'value': '69.0359', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '100'}, {'value': '66.24', 'groupId': 'OG001', 'lowerLimit': '39.38', 'upperLimit': '95'}]}]}, {'title': 'Mental component score at 12months by 36-item Short Form Health Status Survey questionnaire (0-100)', 'categories': [{'measurements': [{'value': '69.2645', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '100'}, {'value': '67.087', 'groupId': 'OG001', 'lowerLimit': '37.75', 'upperLimit': '92.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months, and 12 months', 'description': 'The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome.\n\nThe questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'OG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}], 'classes': [{'title': 'abdominal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'dyspepsia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months, and 12 months', 'description': 'A transient rash and phlebitis, gastrointestinal reaction.', 'unitOfMeasure': 'side effects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'FG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients were enrolled in three centers (Tenth People's Hospital of Tongji University, Shanghai No. 4 People's Hospital and Xinhua Hospital School of Medicine Shanghai Jiaotong University) from January 2015 to December 2019.", 'preAssignmentDetails': 'In the total of 142 included patients, 70 were treated with 99Tc-MDP and 72 were treated with Fosamax.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.\n\n99Tc-MDP: 99Tc-MDP, H20000218'}, {'id': 'BG001', 'title': 'Fosamax', 'description': '70mg po every week for 12 months.\n\nAlendronate Sodium: H20080172'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.29', 'spread': '7.96', 'groupId': 'BG000'}, {'value': '62.73', 'spread': '7.24', 'groupId': 'BG001'}, {'value': '63', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex: Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'TNM staging', 'classes': [{'title': 'T1N0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'T2N0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'T3N0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'T4N0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'TxNx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'TxN0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'T1-2Nx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'T1N0-1, indicated participants had tumor ≤2 cm in greatest dimension, and with (N1) or without (N0)metastasis to lymph node; T2N0-1, tumor size \\>2 cm but ≤4 cm in greatest dimension, and with or without metastasis to lymph node; T3N0-1, tumor size \\>4 cm, and with or without metastasis to lymph node; TxNX, indicated participants had unknown tumor size and unknown metastasis to lymph node; TxN0-1, indicated participants had unknown tumor size, and with or without metastasis to lymph node; T1-2Nx, tumor ≤2 cm(T1) or \\>2 cm but ≤4 cm (T2), and unknown metastasis to lymph node.', 'unitOfMeasure': 'number of participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-16', 'size': 161954, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-22T01:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2014-11-24', 'resultsFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-20', 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change of Bone Mineral Density in Lumbar and Hip', 'timeFrame': 'baseline, 6 months, and 12 months', 'description': 'Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Bone Turnover Markers', 'timeFrame': 'baseline and 12 months', 'description': 'bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)'}, {'measure': 'Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)', 'timeFrame': 'baseline, 6 months, and 12 months', 'description': 'The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome.\n\nThe questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome.'}, {'measure': 'Side Effects', 'timeFrame': '6 months, and 12 months', 'description': 'A transient rash and phlebitis, gastrointestinal reaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['differentiated thyroid cancer', 'bone mineral density', 'thyroid stimulating hormone suppression'], 'conditions': ['Differentiated Thyroid Cancer', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,alendronate sodium in postmenopausal women with DTC under TSH suppression and osteoporosis.', 'detailedDescription': 'Differentiated thyroid cancer (DTC) has become one of the most common endocrine malignancies. According to American Thyroid Association (ATA) and Chinese Thyroid Association (CTA), most of DTC patients undergo total or near total thyroidectomy, radioiodine ablation and TSH (thyroid stimulating hormone) suppression. Osteoporosis (OS) and fractures are important comorbidities in patients with DTC, with potential negative impact on quality of life (QOL) and survival. The main determinant of skeletal fragility in DTC is the TSH suppression. Postmenopausal women with DTC under TSH suppression therapy are more vulnerable to OS. Technetium-99 methylene diphosphonate (99Tc-MDP) is a decay product of 99mTc-MDP (used for bone scintigraphy) and a novel bisphosphonates, which has been used in China for diseases like rheumatoid arthritis (RA), ankylosing spondylitis (AS) and osteochondral lesions of the talus, etc. However, as a member of bisphosphates, little attention has been paid to its anti-OS effect for DTC under TSH suppression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.\n\nExclusion Criteria:\n\n1. patients having medications for osteoporosis before TSH suppression treatment;\n2. secondary osteoporosis ;\n3. severe liver or kidney disease;\n4. myelosuppression;\n5. digestive disease;\n6. long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. This study was approved by the Institutional Review Board of Hospital Research Ethics. All the patients were fully acquainted with their treatment and consented to participate in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT02304757', 'briefTitle': '99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Prospective Trial of 99Tc-MDP and Fosamax in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis Treated With Supraphysiological Doses of Thyroid Hormone', 'orgStudyIdInfo': {'id': 'SanghaiXinhua'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99Tc-MDP', 'description': '15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.', 'interventionNames': ['Drug: 99Tc-MDP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fosamax', 'description': '70mg po every week for 12 months.', 'interventionNames': ['Drug: Fosamax']}], 'interventions': [{'name': '99Tc-MDP', 'type': 'DRUG', 'otherNames': ['Yunke,Technetium [99Tc] Methylenediphosphonate'], 'description': '99Tc-MDP, H20000218', 'armGroupLabels': ['99Tc-MDP']}, {'name': 'Fosamax', 'type': 'DRUG', 'otherNames': ['alendronate sodium'], 'description': 'H20080172', 'armGroupLabels': ['Fosamax']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Nuclear Medicine Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chao Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Chao Ma', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}