Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-04-20 @ 3:31 PM
Study NCT ID:
NCT03006003
Status:
UNKNOWN
Last Update Posted:
2019-01-14
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporosis Treatment in Post-menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D020849', 'term': 'Raloxifene Hydrochloride'}, {'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2016-12-26', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain-derived neurotrophic factor', 'timeFrame': '3 months', 'description': 'Serum brain-derived neurotrophic factor (BDNF) Levels'}], 'secondaryOutcomes': [{'measure': 'Brain-derived neurotrophic factor', 'timeFrame': '1 year', 'description': 'Serum brain-derived neurotrophic factor (BDNF) Levels'}, {'measure': 'Vascular cell adhesion molecule-1', 'timeFrame': '3 months', 'description': 'Serum vascular cell adhesion molecule-1 (VCAM-1) levels'}, {'measure': 'Orexin-A', 'timeFrame': '3 months', 'description': 'Serum Orexin-A levels'}, {'measure': 'Body components', 'timeFrame': '3 months', 'description': 'Fat tissue ratio'}, {'measure': 'Zung self-rating depression scale', 'timeFrame': '3 months', 'description': 'Questionnaire for depressive symptoms'}, {'measure': '5-Item Geriatric Depression Scale', 'timeFrame': '3 months', 'description': 'Questionnaire for Cognitive assessment'}, {'measure': 'The Mini Mental State Examination (MMSE)', 'timeFrame': '3 months', 'description': 'Questionnaire for Cognitive assessment'}, {'measure': 'The Barthel index', 'timeFrame': '3 months', 'description': 'Questionnaire for Cognitive assessment'}, {'measure': 'Instrumental Activities of Daily Living (IADL)', 'timeFrame': '3 months', 'description': 'Questionnaire for Cognitive assessment'}, {'measure': 'ankle-brachial index', 'timeFrame': '3 months', 'description': 'Peripheral artery disease assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Raloxifene', 'Central nervous disorders'], 'conditions': ['Depressive Syndrome']}, 'descriptionModule': {'briefSummary': 'The study will be conducted to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.', 'detailedDescription': 'Fracture is one of the important complications in female. Osteoporosis should be treated in postmenopausal female due to high risk of fracture. Recently, there have been many classes of medications developed for preventing bone loss. Raloxifene, an oral form of anti-osteoporosis medication, has been reported to improved central nervous disorders. Therefore, this study is designed to assess the depressive symptoms and related markers in the postmenopausal female after anti-osteoporosis treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal female\n* Osteoporosis\n\nExclusion Criteria:\n\n* Psychological disorders'}, 'identificationModule': {'nctId': 'NCT03006003', 'briefTitle': 'Osteoporosis Treatment in Post-menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Assessment of Osteoporosis Treatment in Post-menopausal Women', 'orgStudyIdInfo': {'id': 'CE16256A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raloxifene group', 'description': 'Raloxifene treatment', 'interventionNames': ['Drug: Raloxifene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator group', 'description': 'Alendronate treatment', 'interventionNames': ['Drug: Alendronate']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'To refuse anti-osteoporosis treatment'}], 'interventions': [{'name': 'Raloxifene', 'type': 'DRUG', 'otherNames': ['Evista'], 'description': 'Raloxifene tratment more than 4 weeks', 'armGroupLabels': ['Raloxifene group']}, {'name': 'Alendronate', 'type': 'DRUG', 'otherNames': ['FOSAMAX PLUS'], 'description': 'Alendronic acid 70mg with Colecalciferol 70mcg', 'armGroupLabels': ['Comparator group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I Te Lee, MD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw', 'phone': '886-4-23741340'}, {'name': 'I Te Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Te Lee, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'I-Te Lee, MD, PhD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw', 'phone': '+886-4-23741300'}, {'name': 'I-Te Lee, MD, PhD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}