Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 1:00 AM
Study NCT ID:
NCT00212628
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
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': 'C087958', 'term': 'YM 529'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New fragility vertebral fracture'}], 'secondaryOutcomes': [{'measure': 'New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.'}]}, 'conditionsModule': {'keywords': ['ONO-5920', 'osteoporosis', 'bisphosphonate'], 'conditions': ['Involutional Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who was included in study ONO-5920-02 and completed the medication for two years\n2. Other inclusion criteria as specified in the study protocol\n\nExclusion Criteria:\n\n1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator\n2. Patients having secondary osteoporosis or another condition that presents low bone mass\n3. Other exclusion criteria as specified in the study protocol'}, 'identificationModule': {'nctId': 'NCT00212628', 'briefTitle': 'Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan', 'nctIdAliases': ['NCT00189865'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan', 'orgStudyIdInfo': {'id': 'ONO-5920-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Minodronic acid hydrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Chugoku Region Facility'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Chubu Region Facility', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Region Facility'}, {'city': 'Hokuriku', 'country': 'Japan', 'facility': 'Hokuriku Region Facility'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Kanto Region Facility'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Kinki Region Facility'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Kyushu Region Facility'}, {'city': 'Shikoku Region Facility', 'country': 'Japan', 'facility': 'Shikoku Region Facility'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku Region Facility', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Project Leader, Development Planning', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}