Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 12:56 AM
Study NCT ID:
NCT00085956
Status:
COMPLETED
Last Update Posted:
2007-03-09
First Post:
2004-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Arzoxifene on Bone Mass and the Uterus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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': 'C115121', 'term': 'LY 353381'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-02'}, 'lastUpdateSubmitDate': '2007-03-07', 'studyFirstSubmitDate': '2004-06-18', 'studyFirstSubmitQcDate': '2004-06-21', 'lastUpdatePostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women'}, {'measure': 'The effects of arzoxifene on the uterus (womb) in post menopausal women'}, {'measure': 'The safety of arzoxifene and any side effects that might be associated with its use'}], 'secondaryOutcomes': [{'measure': 'The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density'}, {'measure': 'The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease'}, {'measure': 'The effects of arzoxifene on breast density'}]}, 'conditionsModule': {'conditions': ['Postmenopausal Bone Loss']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine:\n\n* The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women.\n* The effects of arzoxifene on the uterus (womb) in postmenopausal women.\n* The effects of arzoxifene on blood tests that measure changes in bone rebuilding in postmenopausal women with low bone density.\n* The effects of arzoxifene on blood lipids (fats) and other blood markers of heart disease risk.\n* The safety of arzoxifene and any side effects that might be associated with its use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 45 to 60 years of age, inclusive\n* At least 2 years since last menstrual cycle\n* Intact uterus (womb).\n\nExclusion Criteria:\n\n* Existing fracture of the spine.\n* Bone disorders, other than low bone mass\n* History of cancer in the last 5 years. Also, any history, at any time, of breast cancer or cancer of the lining of the uterus.\n* Abnormal or unexplained vaginal bleeding.'}, 'identificationModule': {'nctId': 'NCT00085956', 'briefTitle': 'Effects of Arzoxifene on Bone Mass and the Uterus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Effects of Arzoxifene on Bone Mineral Density and Endometrial Histology in Postmenopausal Women.', 'orgStudyIdInfo': {'id': '8537'}, 'secondaryIdInfos': [{'id': 'H4Z-MC-GJAE'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Arzoxifene', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}