Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-03-08 @ 5:06 AM
Study NCT ID:
NCT02156960
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2014-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic 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': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2014-05-31', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of bone mineral density', 'timeFrame': 'every 4-6 months', 'description': 'Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.'}], 'secondaryOutcomes': [{'measure': 'Changes of bone turnover markers', 'timeFrame': 'every 3-6 months', 'description': 'Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.'}]}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '26666998', 'type': 'DERIVED', 'citation': 'Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.'}]}, 'descriptionModule': {'briefSummary': 'It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoporotic patients\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02156960', 'briefTitle': 'Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'orgStudyIdInfo': {'id': 'Deno-PTH2365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denosumab and/or teriparatide treatment', 'description': 'Denosumab and/or teriparatide treatment in osteoporotic patients', 'interventionNames': ['Drug: Denosumab treatment in osteoporotic patients', 'Drug: Teriparatide treatment in osteoporotic patients', 'Drug: Denosumab and teriparatide treatment in osteoporotic patients']}], 'interventions': [{'name': 'Denosumab treatment in osteoporotic patients', 'type': 'DRUG', 'description': 'To examine the effectiveness of denosumab in osteoporotic patients', 'armGroupLabels': ['Denosumab and/or teriparatide treatment']}, {'name': 'Teriparatide treatment in osteoporotic patients', 'type': 'DRUG', 'description': 'To examine the effectiveness of teriparatide in osteoporotic patients', 'armGroupLabels': ['Denosumab and/or teriparatide treatment']}, {'name': 'Denosumab and teriparatide treatment in osteoporotic patients', 'type': 'DRUG', 'description': 'To examine the effectiveness of denosumab and teriparatide in osteoporotic patients', 'armGroupLabels': ['Denosumab and/or teriparatide treatment']}]}, '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, MD, PhD', 'role': 'CONTACT', 'email': 'yxn14@aol.jp', 'phone': '+81-263-37-2659'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shinshu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yukio Nakamura', 'investigatorAffiliation': 'Shinshu University'}}}}