Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-16 @ 6:49 AM
Study NCT ID:
NCT03755193
Status:
RECRUITING
Last Update Posted:
2021-09-21
First Post:
2018-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D004164', 'term': 'Diphosphonates'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2026-11-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2018-11-23', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone', 'timeFrame': 'Change from Baseline Values of bone mineral density at 2 years in each group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:\n\nSERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoporosis patients\n\nExclusion Criteria:\n\n* not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant'}, 'identificationModule': {'nctId': 'NCT03755193', 'briefTitle': 'Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'officialTitle': 'Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients', 'orgStudyIdInfo': {'id': 'DMAb switch 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SERM plus ELD', 'description': 'To examine the effects of SERM plus ELD in osteoporosis patients', 'interventionNames': ['Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"', 'Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"', 'Drug: ELD "Edirol®Tablet 0.75ug"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BP plus ELD', 'description': 'To examine the effects of BP plus ELD in osteoporosis patients', 'interventionNames': ['Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"', 'Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"', 'Drug: ELD "Edirol®Tablet 0.75ug"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ELD alone', 'description': 'To examine the effects of ELD alone in osteoporosis patients', 'interventionNames': ['Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"', 'Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"', 'Drug: ELD "Edirol®Tablet 0.75ug"']}], 'interventions': [{'name': 'SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"', 'type': 'DRUG', 'description': 'To examine the effects of SERM and ELD in osteoporosis patients', 'armGroupLabels': ['BP plus ELD', 'ELD alone', 'SERM plus ELD']}, {'name': 'Bisphosphonates and ELD "Edirol®Tablet 0.75ug"', 'type': 'DRUG', 'description': 'To examine the effects of BP and ELD in osteoporosis patients', 'armGroupLabels': ['BP plus ELD', 'ELD alone', 'SERM plus ELD']}, {'name': 'ELD "Edirol®Tablet 0.75ug"', 'type': 'DRUG', 'description': 'To examine the effects of ELD in osteoporosis patients', 'armGroupLabels': ['BP plus ELD', 'ELD alone', 'SERM plus ELD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3908621', 'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yukio Nakamura, MD, PhD', 'role': 'CONTACT', 'email': 'yxn14@aol.jp', 'phone': '+81-263-37-2659'}, {'name': 'Yukio Nakamura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yukio Nakamura', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}], 'centralContacts': [{'name': 'Yukio Nakamura', 'role': 'CONTACT', 'email': 'yxn14@aol.jp', 'phone': '+81263372576'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shinshu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at Shinshu University School of Medicine', 'investigatorFullName': 'Yukio Nakamura', 'investigatorAffiliation': 'Shinshu University'}}}}