Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00212667
Status:
COMPLETED
Last Update Posted:
2012-10-11
First Post:
2005-09-13
Is NOT Gene Therapy:
False
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, '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 spoine (L2-4 BMD), lower back pain'}]}, 'conditionsModule': {'keywords': ['ONO-5920, osteoporosis, bisphosphonate'], 'conditions': ['Involutional Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '19101754', 'type': 'DERIVED', 'citation': 'Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.'}]}, '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 with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis\n2. Patients having radiographically confirmed vertebral (T4-L4) fractures\n3. Other inclusion criteria as specified in the study protocol\n\nExclusion Criteria:\n\n1. Patients having secondary osteoporosis or another condition that presents low bone mass\n2. Patients having findings on X-ray that affect evaluation of vertebral fracture\n3. Patients that have been administered bisphosphonate derivatives\n4. Other exclusion criteria as specified in the study protocol'}, 'identificationModule': {'nctId': 'NCT00212667', 'briefTitle': 'Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan', 'nctIdAliases': ['NCT00189891'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan', 'orgStudyIdInfo': {'id': 'ONO-5920-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ONO-5920', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Project Leader, Development Planning', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. LtTd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}