Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 5:52 PM
Study NCT ID:
NCT00859560
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2009-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-10', 'studyFirstSubmitDate': '2009-03-10', 'studyFirstSubmitQcDate': '2009-03-10', 'lastUpdatePostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone fracture incidence', 'timeFrame': 'Time since starting Arimidex'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Time since starting Arimidex'}, {'measure': 'Bone density measurement', 'timeFrame': 'Time since starting Arimidex'}]}, 'conditionsModule': {'keywords': ['Breast cancer', 'post-menopausal women', 'Arimidex', 'bone fracture'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post-menoposal breast cancer patients who were previousely registered in clinical experience investigation with Arimidex 1mg as adjuvant therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00859560', 'briefTitle': 'Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Retrospective Survey of Bone Fracture in Post-Menopausal Breast Cancer Patients With Arimidex 1 mg as Adjuvant Therapy', 'orgStudyIdInfo': {'id': 'NIS-OJP-ARI-2007/1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AstraZeneca Japan Medical Director MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alain Huvenne, Senior Medical Marketing Director', 'oldOrganization': 'AstraZeneca KK'}}}}