Viewing Study NCT00305695


Ignite Creation Date: 2025-12-24 @ 1:40 PM
Ignite Modification Date: 2026-04-01 @ 8:54 PM
Study NCT ID: NCT00305695
Status: COMPLETED
Last Update Posted: 2020-03-24
First Post: 2006-03-21
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'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': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linda.gedeon@roswellpark.org', 'phone': '716-845-1169', 'title': 'Linda Gedeon on behalf of James Kauderer, MA, BS', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV', 'otherNumAtRisk': 80, 'otherNumAffected': 45, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.', 'otherNumAtRisk': 78, 'otherNumAffected': 19, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, Gu - Vagina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Sinus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Edema: Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood Alteration - Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood Alteration - Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy-Sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Vagina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Chest /Thorax Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Head/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Extremity-Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Abdominal Pain Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: External Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Incontinence, Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu-Like Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.025', 'groupId': 'OG000', 'lowerLimit': '-0.240', 'upperLimit': '0.077'}, {'value': '-0.086', 'groupId': 'OG001', 'lowerLimit': '-0.308', 'upperLimit': '0.067'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 Months', 'description': 'To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated Patients'}, {'type': 'PRIMARY', 'title': 'Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.001', 'groupId': 'OG000', 'lowerLimit': '-0.199', 'upperLimit': '0.093'}, {'value': '-0.094', 'groupId': 'OG001', 'lowerLimit': '-0.349', 'upperLimit': '0.280'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated Patients'}, {'type': 'PRIMARY', 'title': 'Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.101', 'groupId': 'OG000', 'lowerLimit': '-0.400', 'upperLimit': '1.500'}, {'value': '-0.052', 'groupId': 'OG001', 'lowerLimit': '-0.212', 'upperLimit': '0.307'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated patients'}, {'type': 'PRIMARY', 'title': 'Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'OG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.003', 'groupId': 'OG000', 'lowerLimit': '-0.142', 'upperLimit': '0.067'}, {'value': '-0.058', 'groupId': 'OG001', 'lowerLimit': '-0.185', 'upperLimit': '0.009'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months', 'unitOfMeasure': 'g/cm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and Treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'FG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Withdrawal by subject prior to 18 month', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Did not have baseline scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'GOG 0215 accrued 160 patients from November 2005 to April 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Zoledroic Acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nLaboratory Biomarker Analysis: Correlative studies\n\nZoledronic Acid: Given IV'}, {'id': 'BG001', 'title': 'Arm II (Clinical Observation)', 'description': 'Patients are observed for 18 months after surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible and Evaluable subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2006-03-21', 'resultsFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2006-03-21', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-09', 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 9 Months', 'timeFrame': '9 Months', 'description': 'To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 9 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).'}, {'measure': 'Bone Mineral Density of the Lumbar Spine as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at 18 Months', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid administered every 6 months on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries), as compared with observation alone. This is to be evaluated by measuring the change from baseline to 18 months in bone mineral density (BMD) of the lumbar spine, specifically L1-L4 dual energy X-ray absorptiometry (DEXA).'}, {'measure': 'Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Right Hip', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid on the change in BMD of the right hip following treatment, evaluated by measuring the change from baseline to 18 months'}, {'measure': 'Bone Mineral Density of the Total Hip as Measured by DEXA Scan on Left Hip', 'timeFrame': '18 months', 'description': 'To compare the effect of zoledronic acid on the change in BMD of the left hip following treatment, evaluated by measuring the change from baseline to 18 months'}]}, 'conditionsModule': {'conditions': ['Hereditary Breast and Ovarian Cancer Syndrome', 'Osteoporosis', 'Ovarian Carcinoma']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Compare the effect of zoledronate vs observation on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries) in patients undergoing excision of both ovaries.\n\nSECONDARY OBJECTIVE:\n\nI. Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens.\n\nTERTIARY OBJECTIVE:\n\nI. Compare the effect of zoledronate vs observation on biochemical markers of bone resorption and bone formation (N-telopeptide and bone specific alkaline phosphatase) during 1 year of treatment.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\nAll patients undergo surgery, with removal of both ovaries, in month 1. All patients are requested to take calcium supplements twice daily and a multivitamin containing vitamin D once daily beginning in month 1 and continuing for up to 18 months.\n\nARM I: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.\n\nARM II: Patients are observed for 18 months after surgery.\n\nIn both arms, patients complete physical activity questionnaires at baseline and in months 3, 9, 15, and 18. Patients undergo bone mineral density test of lumbar spine and total hip at baseline and in months 9 and 18. Patients also undergo blood collection at baseline and periodically during the study for biomarker studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have elected to undergo, or who have undergone (within 8 weeks) a surgical procedure that results (at minimum) in the absence of both ovaries\n\n * Patients enrolled in the screening arm of GOG-0199 who decide to undergo surgery are potentially eligible for GOG-0215\n* Baseline bone mass density (BMD) T-Score ? -1.5 (no more than 1.5 standard deviation below the mean value for young adults) on both the total lumbar spine (L1-L4 region, not individual bones) and bilateral hip\n* Patients who had/have at least 1 intact ovary at the time of surgery are eligible\n* No prior distant metastatic malignant disease within the past 5 years\n\n * Patients treated for stage M1 (any T, any N) diagnosis in the past 5 years are ineligible\n * Patients who achieved a complete response after treatment for rM0 (any T, any N) within the past 5 years are eligible\n* Premenopausal\\*\n\n * Last menstrual cycle occurred \\< 12 months prior to study enrollment\n* GOG performance status 0-2\n* Creatinine clearance \\> 60 mL/min\n* No clinical or radiological evidence of existing fracture of the lumbar spine or bilateral hip\n* No history of hip of spine fracture with low-intensity trauma or not associated with trauma\n* No uncontrolled seizure disorder associated with falls\n* No diseases that influence bone metabolism, including any of the following:\n\n * Paget?s disease\n * Osteogenesis imperfecta\n * Uncontrolled thyroid or parathyroid dysfunction within 12 months prior to study entry\n* No other nonmalignant systemic disease, including any of the following:\n\n * Uncontrolled infection\n * Uncontrolled type 2 diabetes mellitus\n * Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up\n\n * History of thrombosis or thromboembolism allowed\n* No known HIV positivity\n* No known hypersensitivity to zoledronate or other bisphosphonates\n* No psychiatric, psychological, or other conditions that prevent fully informed consent\n* No other active malignancy except nonmelanoma skin cancer\n* No history of any medical condition that places the patient at risk for donating blood for research purposes (e.g., chronic infectious diseases, sever anemia, or hemophilia)\n* Not pregnant\n* Negative pregnancy test\n* No current active dental problems, including any of the following:\n\n * Infection of the teeth or jawbone (maxilla or mandible)\n * Dental or fixture trauma\n * Current or prior diagnosis of osteonecrosis of the jaw\n * Exposed bone in the mouth\n * Slow healing after dental procedures\n* No recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction or implants)\n* No prior treatment for osteoporosis\n* No adjuvant radiotherapy within the past 31 days\n* No chemotherapy within the past 30 days\n* No prior surgery to the hip or spine\n* No prior systemic sodium fluoride for \\> 3 months during the past 2 years\n* No more than 30 days use in the past 12 months and no concurrent tamoxifen, raloxifene, or any other selective estrogen-receptor modulator (SERM)\n* More than 12 months since prior and no concurrent endocrine therapy\n\n * Insulin and/or oral antidiabetic medications allowed\n * Thyroid hormone replacement allowed\n* More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone)\n\n * Prior or concurrent oral contraceptives allowed\n * Systemic (oral) hormone replacement therapy following surgery not allowed\n\n * Vaginal (non-systemic) estrogen allowed\n* More than 12 months since prior and no concurrent oral or IV bisphosphonate\n* More than 12 months since prior and no concurrent anabolic steroids or growth hormone\n* More than 12 months since prior and no concurrent systemic corticosteroids\n\n * Concurrent short term corticosteroid therapy (to prevent/treat chemotherapy-induced nausea/vomiting) allowed\n* More than 6 months since prior and no concurrent Tibolone\n* More than 2 weeks since prior and no concurrent drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate)\n* No concurrent chemotherapy or radiotherapy\n* No concurrent aromatase inhibitors\n* Concurrent enrollment on protocol GOG-0199 allowed'}, 'identificationModule': {'nctId': 'NCT00305695', 'briefTitle': 'Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries', 'orgStudyIdInfo': {'id': 'GOG-0215'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00589', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NCI-P6966'}, {'id': 'NOVARTIS-GOG-0215'}, {'id': 'CDR0000462217'}, {'id': 'NCI-06-C-0204'}, {'id': 'GOG-0215', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-0215', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'GOG-0215', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA101165', 'link': 'https://reporter.nih.gov/quickSearch/U10CA101165', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (zoledroic acid)', 'description': 'Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Zoledronic Acid']}, {'type': 'NO_INTERVENTION', 'label': 'Arm II (clinical observation)', 'description': 'Patients are observed for 18 months after surgery.'}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (zoledroic acid)']}, {'name': 'Zoledronic Acid', 'type': 'DRUG', 'otherNames': ['[1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic Acid', 'CGP 42446', 'CGP42446A', 'NDC-Zoledronate', 'Reclast', 'ZOL 446', 'Zometa'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (zoledroic acid)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center-North Campus', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center/Disney Family Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Gynecologic Oncology Group', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose-Saint Francis Healthcare', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'SCL Health Saint Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Colorado Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80539', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'McKee Medical Center', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'SCL Health Lutheran Medical Center', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Hospital of Central Connecticut', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System-Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Cancer Center at Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '96859', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem-Evanston Hospital', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine Central DuPage Hospital', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Saint Vincent Hospital and Health Care Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Memorial Hospital of South Bend', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa/Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Menorah Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': "Saint Luke's South Hospital", 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Baptist Health Lexington', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Hospital Pavilion and Medical Campus', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Franklin Square Medical Center/Weinberg Cancer Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21921', 'city': 'Elkton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Hospital of Cecil County', 'geoPoint': {'lat': 39.60678, 'lon': -75.83327}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital-Royal Oak', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Truman Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64116', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'North Kansas City Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64118', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Hematology and Oncology Associates Incorporated', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64086', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's East - Lee's Summit", 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '64507', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Regional Medical Center', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital Springfield', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CoxHealth South Hospital', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis-Cape Girardeau CCOP', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Hospital and Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center of Hope at Renown Medical Center', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital University Medical Center', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Memorial', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health/Center for Advanced Medicine', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27215', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cone Health Cancer Center at Alamance Regional', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Presbyterian Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'country': 'United States', 'facility': 'FirstHealth of the Carolinas-Moore Regional Hospital', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati/Barrett Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital - Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Methodist Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43222', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel Health Center West', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Seidman Cancer Center at Lake Health Mentor Campus', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Cancer Specialists and Research Institute-Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Health NCORP', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women and Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': "Chattanooga's Program in Women's Oncology", 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'The Don and Sybil Harrington Cancer Center', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University/Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic Gynecological Oncology', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Saint Vincent Hospital Cancer Center Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora West Allis Medical Center', 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}], 'overallOfficials': [{'name': 'David S Alberts', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}