Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01381393
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2011-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
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': 'D000077557', 'term': 'Ibandronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 659}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of adverse event after ibandronate administration', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The number of unexpected adverse events after ibandronate administration', 'timeFrame': '6 months'}, {'measure': 'The number of serious adverse events after ibandronate administration', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'ibandronate'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This is an open label, multi-centre, non-interventional post-marketing surveillance.', 'detailedDescription': 'This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate administered in Korean patients according to the prescribing information.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients administrated ibandronate with postmenopausal osteoporosis in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects must satisfy the following criteria at study entry:\n\n1. Subjects diagnosed with osteoporosis in postmenopausal women.\n2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol\n3. Subjects with no experience of treatment using ibandronate.\n4. Subjects who are administered of ibandronate in normal prescription use\n\nExclusion Criteria:\n\nConsidering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate following the locally approved Prescribing Information.\n\nThe following criteria should be checked at the time of study entry.\n\nAccording to contraindication on the prescribing information, ibandronate should not be administered to the following patients:\n\n1. Patients with known hypersensitivity to ibandronate or to any of its excipients\n2. Uncorrected hypocalcemia\n3. Inability to stand or sit upright for at least 60 minutes'}, 'identificationModule': {'nctId': 'NCT01381393', 'acronym': 'BONPMS', 'briefTitle': 'BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information', 'orgStudyIdInfo': {'id': '110603'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ibandronate', 'description': 'The subjects with osteoporosis in postmenopausal women', 'interventionNames': ['Drug: Ibandronate']}], 'interventions': [{'name': 'Ibandronate', 'type': 'DRUG', 'otherNames': ['BONVIVA'], 'description': "Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.", 'armGroupLabels': ['Ibandronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}