Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT04149405
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2019-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'C537525', 'term': 'Sclerosteosis'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010512', 'term': 'Periodontal Index'}], 'ancestors': [{'id': 'D003753', 'term': 'Dental Health Surveys'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011636', 'term': 'Public Health Dentistry'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'feyza_otan@yahoo.com', 'phone': '+905322535106', 'title': 'Feyza Otan Özden', 'organization': 'OndokusMU'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were not monitored/assessed', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in any participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Participants received periodontal phase 1 treatment and used bisphosphonate.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Participants received periodontal phase 1 treatment.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C', 'description': 'Participants used bisphosphonate.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D', 'description': 'Participants did not receive any treatment.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sost Values for 6th Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'scaling and root planning, bisphosphonate therapy (zoledronic acid)\n\nperiodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.\n\nbisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)\n\nGCF: gingival crevicular fluid collection by the same investigator.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'scaling and root planning, no bisphosphonate therapy\n\nperiodontal phase 1 therapy: periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia.\n\nGCF: gingival crevicular fluid collection by the same investigator.'}, {'id': 'OG002', 'title': 'Group C', 'description': 'bisphosphonate therapy (zoledronic acid)\n\nbisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.)\n\nGCF: gingival crevicular fluid collection by the same investigator.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Systemically and periodontally healthy controls No intervention has been made'}], 'classes': [{'categories': [{'measurements': [{'value': '1389.177', 'spread': '670.834', 'groupId': 'OG000'}, {'value': '1085.405', 'spread': '618.136', 'groupId': 'OG001'}, {'value': '1596.585', 'spread': '841.026', 'groupId': 'OG002'}, {'value': '2131.87', 'spread': '485.78', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'levels of sclerostin in 6th month', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dkk-1 Values for 6th Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': '* Subjects with chronic periodontitis and osteoporosis.\n* Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.\n\nPhase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.\n\nBisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year'}, {'id': 'OG001', 'title': 'Group B', 'description': '* Subjects with chronic periodontitis and systemically healthy.\n* Phase 1 periodontal theraphy was administered to the subjects.\n\nPhase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.'}, {'id': 'OG002', 'title': 'Group C', 'description': '* Subjects with periodontally healthy and osteoporosis.\n* Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.\n\nBisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Systemically and periodontally healthy controls No intervention has been made'}], 'classes': [{'categories': [{'measurements': [{'value': '3358.265', 'spread': '1477.199', 'groupId': 'OG000'}, {'value': '1963.185', 'spread': '966.451', 'groupId': 'OG001'}, {'value': '3263.665', 'spread': '2298.590', 'groupId': 'OG002'}, {'value': '4269.39', 'spread': '1734.73', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'levels of dickkopf-related protein-1 in 6th month', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sost Values for 12th Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': '* Subjects with chronic periodontitis and osteoporosis.\n* Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.\n\nPhase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.\n\nBisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year'}, {'id': 'OG001', 'title': 'Group B', 'description': '* Subjects with chronic periodontitis and systemically healthy.\n* Phase 1 periodontal theraphy was administered to the subjects.\n\nPhase 1 periodontal therapy: Scaling and root planning with ultrasonic and hand instruments under local anesthesia.'}, {'id': 'OG002', 'title': 'Group C', 'description': '* Subjects with periodontally healthy and osteoporosis.\n* Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.\n\nBisphosphonate therapy: Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Systemically and periodontally healthy controls No intervention has been made'}], 'classes': [{'categories': [{'measurements': [{'value': '1702.265', 'spread': '1012.124', 'groupId': 'OG000'}, {'value': '1347.330', 'spread': '876.383', 'groupId': 'OG001'}, {'value': '1114.988', 'spread': '368.840', 'groupId': 'OG002'}, {'value': '2131.87', 'spread': '485.78', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 month', 'description': 'levels of sclerostin in 12th month', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dkk-1 Values for 12th Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': '-Subjects with chronic periodontitis and osteoporosis.'}, {'id': 'OG001', 'title': 'Group B', 'description': '-Subjects with chronic periodontitis and systemically healthy.'}, {'id': 'OG002', 'title': 'Group C', 'description': '-Subjects with periodontally healthy and osteoporosis.'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Systemically and periodontally healthy controls No intervention has been made'}], 'classes': [{'categories': [{'measurements': [{'value': '3440.67', 'spread': '2347.112', 'groupId': 'OG000'}, {'value': '3203.802', 'spread': '1706.081', 'groupId': 'OG001'}, {'value': '2490.553', 'spread': '841.512', 'groupId': 'OG002'}, {'value': '4269.39', 'spread': '1734.73', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'levels of dickkopf-related protein-1 in 12th month', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'subjects with chronic periodontitis and osteoporosis'}, {'id': 'FG001', 'title': 'Group B', 'description': 'subjects with chronic periodontitis and systemically healthy'}, {'id': 'FG002', 'title': 'Group C', 'description': 'subjects with periodontally healthy and osteoporosis'}, {'id': 'FG003', 'title': 'Group D', 'description': 'systemically and periodontally healthy controls'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Postmenopausal women who were admitted to Ondokuz Mayıs University (OMU), Faculty of Medicine, Department of Endocrinology and Metabolism between 2016 and 2018.\n\nPatients eligible for the study were directed to OMU, Faculty of Dentistry, Department of Periodontology for periodontal examination after obtaining medical records.', 'preAssignmentDetails': 'Smokers and subjects who had received antibiotic treatment in the last 3 months and/or periodontal treatment in the last 6 months were excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'subjects with chronic periodontitis and osteoporosis'}, {'id': 'BG001', 'title': 'Group B', 'description': 'subjects with chronic periodontitis and systemically healthy'}, {'id': 'BG002', 'title': 'Group C', 'description': 'subjects with periodontally healthy and osteoporosis'}, {'id': 'BG003', 'title': 'Group D', 'description': 'systemically and periodontally healthy controls'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.67', 'spread': '4.77', 'groupId': 'BG000'}, {'value': '57.00', 'spread': '4.39', 'groupId': 'BG001'}, {'value': '56.45', 'spread': '3.88', 'groupId': 'BG002'}, {'value': '56.30', 'spread': '3.91', 'groupId': 'BG003'}, {'value': '56.88', 'spread': '4.15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'baseline sost values', 'classes': [{'categories': [{'measurements': [{'value': '494.096', 'spread': '99.840', 'groupId': 'BG000'}, {'value': '634.731', 'spread': '152.554', 'groupId': 'BG001'}, {'value': '1023.071', 'spread': '512.733', 'groupId': 'BG002'}, {'value': '2131.87', 'spread': '485.784', 'groupId': 'BG003'}, {'value': '1103.417', 'spread': '751.080', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'initial sclerostin values', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'baseline dkk-1 levels', 'classes': [{'categories': [{'measurements': [{'value': '1031.323', 'spread': '506.985', 'groupId': 'BG000'}, {'value': '1264.632', 'spread': '492.691', 'groupId': 'BG001'}, {'value': '2630.430', 'spread': '1679.080', 'groupId': 'BG002'}, {'value': '4269.394', 'spread': '1734.732', 'groupId': 'BG003'}, {'value': '2358.505', 'spread': '1801.692', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'initial dickkopf-related protein-1 values', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-30', 'size': 55447, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-11T12:44', 'hasProtocol': False}, {'date': '2018-12-28', 'size': 69843, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-11T13:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2019-10-12', 'resultsFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-05', 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sost Values for 6th Month', 'timeFrame': '6 months', 'description': 'levels of sclerostin in 6th month'}, {'measure': 'Dkk-1 Values for 6th Month', 'timeFrame': '6 months', 'description': 'levels of dickkopf-related protein-1 in 6th month'}], 'secondaryOutcomes': [{'measure': 'Sost Values for 12th Month', 'timeFrame': '12 month', 'description': 'levels of sclerostin in 12th month'}, {'measure': 'Dkk-1 Values for 12th Month', 'timeFrame': '12 months', 'description': 'levels of dickkopf-related protein-1 in 12th month'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sclerostin', 'dickkopf-related protein-1'], 'conditions': ['Osteoporosis, Postmenopausal', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '23702386', 'type': 'BACKGROUND', 'citation': 'Hampson G, Edwards S, Conroy S, Blake GM, Fogelman I, Frost ML. The relationship between inhibitors of the Wnt signalling pathway (Dickkopf-1(DKK1) and sclerostin), bone mineral density, vascular calcification and arterial stiffness in post-menopausal women. Bone. 2013 Sep;56(1):42-7. doi: 10.1016/j.bone.2013.05.010. Epub 2013 May 20.'}, {'pmid': '1581119', 'type': 'BACKGROUND', 'citation': 'Papapoulos SE, Landman JO, Bijvoet OL, Lowik CW, Valkema R, Pauwels EK, Vermeij P. The use of bisphosphonates in the treatment of osteoporosis. Bone. 1992;13 Suppl 1:S41-9. doi: 10.1016/s8756-3282(09)80009-4.'}, {'pmid': '26435630', 'type': 'BACKGROUND', 'citation': 'Juluri R, Prashanth E, Gopalakrishnan D, Kathariya R, Devanoorkar A, Viswanathan V, Romanos GE. Association of Postmenopausal Osteoporosis and Periodontal Disease: A Double-Blind Case-Control Study. J Int Oral Health. 2015 Sep;7(9):119-23.'}, {'pmid': '16018754', 'type': 'RESULT', 'citation': 'Lane N, Armitage GC, Loomer P, Hsieh S, Majumdar S, Wang HY, Jeffcoat M, Munoz T. Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study. J Periodontol. 2005 Jul;76(7):1113-22. doi: 10.1902/jop.2005.76.7.1113.'}, {'pmid': '26367496', 'type': 'RESULT', 'citation': 'Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.'}, {'pmid': '24576302', 'type': 'RESULT', 'citation': 'Napimoga MH, Nametala C, da Silva FL, Miranda TS, Bossonaro JP, Demasi AP, Duarte PM. Involvement of the Wnt-beta-catenin signalling antagonists, sclerostin and dickkopf-related protein 1, in chronic periodontitis. J Clin Periodontol. 2014 Jun;41(6):550-7. doi: 10.1111/jcpe.12245.'}]}, 'descriptionModule': {'briefSummary': 'Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt / β-catenin signal is controlled by physiological antagonists, including dickkopf released from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and increased SOST in the late period were reported. Increased bone formation after bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with increased serum SOST level. The aim of our study is to investigate the effect of bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition metabolism in periodontally healthy and periodontally diseased tooth regions and gingival health with the clinical data by investigating the SOST and DDK-1 molecules that play role in bone destruction mechanism.', 'detailedDescription': 'This study aims to reveal the effect of initial periodontal treatment together with bisphosphonate on sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival crevicular fluid (GCF) of patients with osteoporosis.\n\nClinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and those using bisphosphonate (Group A, n=12), with chronic periodontitis and otherwise healthy (Group B, n=10), without chronic periodontitis and those using bisphosphonate (Group C, n=11), systemically and periodontally healthy controls (Group D, n=10) at the baseline.\n\nGCF sampling were recorded and repeated at the 6th and 12th months in Group A, B and C. SOST and DKK-1 values were measured by ELISA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '51 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with T scores less than -2.5 (groups A and C)\n* The periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (BOP), ≥5 mm pocket depth (PD) and ≥6 mm clinical attachment loss (CAL).\n* The clinically healthy control groups were selected on the basis of no radiographic bone loss or CAL and PD≤3 mm.\n\nExclusion Criteria:\n\n* Any known systemic disease rather than osteoporosis\n* Smoking\n* Antibiotic therapy within the last 3 months\n* Periodontal treatment in the last 6 months'}, 'identificationModule': {'nctId': 'NCT04149405', 'briefTitle': 'Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Investigation of the Effects of Bisphosphonate on the Gingival Crevicular Fluid Levels of Sclerostin and the DKK-1 in Individuals With Postmenopausal Osteoporosis With Periodontal Changes', 'orgStudyIdInfo': {'id': 'KAEK 2016/100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': '* Subjects with chronic periodontitis and osteoporosis.\n* Phase 1 periodontal therapy and bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.', 'interventionNames': ['Procedure: Phase 1 periodontal therapy', 'Drug: Bisphosphonate therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': '* Subjects with chronic periodontitis and systemically healthy.\n* Phase 1 periodontal theraphy was administered to the subjects.', 'interventionNames': ['Procedure: Phase 1 periodontal therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': '* Subjects with periodontally healthy and osteoporosis.\n* Bisphosphonate therapy ( Aclasta: intravenous infusion of 5 mg of zoledronic acid once a year) were administered to the subjects.', 'interventionNames': ['Drug: Bisphosphonate therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Group D', 'description': '* Systemically and periodontally healthy controls\n* No intervention has been made.'}], 'interventions': [{'name': 'Phase 1 periodontal therapy', 'type': 'PROCEDURE', 'otherNames': ['Periodontal treatment'], 'description': 'Scaling and root planning with ultrasonic and hand instruments under local anesthesia.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Bisphosphonate therapy', 'type': 'DRUG', 'otherNames': ['Osteoporosis treatment'], 'description': 'Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year', 'armGroupLabels': ['Group A', 'Group C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eser Acarel, PhD,Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University, School of Dentistry, Department of Periodontology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Feyza Otan ÖZDEN', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}