Viewing Study NCT00622505

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 3:26 AM

Ignite Modification Date: 2026-03-06 @ 8:05 AM

Study NCT ID: NCT00622505

Status: COMPLETED

Last Update Posted: 2021-05-26

First Post: 2008-02-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 Years', 'description': 'Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.', 'eventGroups': [{'id': 'EG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 70, 'seriousNumAtRisk': 79, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 41, 'seriousNumAtRisk': 42, 'deathsNumAffected': 2, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, 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'MedDRA (unspecified)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥1 SRE at the End of 1 Year on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': 'Upper and lower limits of 95% CI were not estimable due to the smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in this study.'}, {'type': 'SECONDARY', 'title': 'Time to First SRE on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95 % CI was not estimable because there were too few events (low incidence of observed SREs) to calculate the median and 95 % CI.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.', 'unitOfMeasure': 'years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in this study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Pathologic Bone Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI were not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.15'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI were not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1 and 2', 'description': 'Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Spinal Cord Compression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.15'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1 and 2', 'description': 'Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Radiation to Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI were not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.18'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI were not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.20'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1 and 2', 'description': 'Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Surgery to Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.07'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1 and 2', 'description': 'Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced HCM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.07'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.00', 'comment': 'Upper and lower limits of 95% CI was not estimable due to smaller number of participants with the event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Years 1 and 2', 'description': 'HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter \\[mmol/L\\]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Skeletal Related Event (SRE) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Years 1 and 2', 'description': 'The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.', 'unitOfMeasure': 'number of SRE/total follow-up time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '15.63', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '11.50', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '19.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '15.66', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '13.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '9.24', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '18.39', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '17.54', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '10.99', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '15.50', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '18.51', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '17.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)', 'description': 'uNTx is a biomarker used to measure the rate of bone turnover found in urine.', 'unitOfMeasure': 'nmol/mmol creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.'}, {'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'OG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CI was not estimable because there were too few events (low incidence of observed deaths) to calculate the median and 95% CI.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and 95% CI was not estimable because there were too few events (low incidence of observed deaths) to calculate the median and 95% CI.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years', 'description': 'Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method.', 'unitOfMeasure': 'years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all participants who were enrolled in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'FG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Abnormal Laboratory Value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Abnormal Test Procedure Result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at 67 centers in the United States (US) from 07 November 2007 to 03 April 2012.', 'preAssignmentDetails': 'A total of 121 participants with Advanced Multiple Myeloma were enrolled in this study. By study design, any participants who had a Skeletal-related Event (SRE) in Zoledronic Acid Every 12 Weeks group was switched to Zoledronic Acid Every 4 Weeks or 12 Weeks group and reported as Zoledronic Acid Every 4 Weeks or 12 Weeks group, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zoledronic Acid Every 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( \\<50 nmol/mmol creatinine).'}, {'id': 'BG001', 'title': 'Zoledronic Acid Every 4 Weeks or 12 Weeks', 'description': 'Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or \\<50 nmol/mmol creatinine, respectively).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.91', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '12.66', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '10.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set included all participants who were enrolled in this study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2012-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2008-02-14', 'resultsFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With ≥1 SRE at the End of 1 Year on Study', 'timeFrame': '1 year', 'description': 'SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.'}], 'secondaryOutcomes': [{'measure': 'Time to First SRE on Study', 'timeFrame': 'Up to 2 years', 'description': 'The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Who Experienced Pathologic Bone Fracture', 'timeFrame': 'Years 1 and 2', 'description': 'Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma.'}, {'measure': 'Percentage of Participants Who Experienced Spinal Cord Compression', 'timeFrame': 'Years 1 and 2', 'description': 'Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.'}, {'measure': 'Percentage of Participants Who Experienced Radiation to Bone', 'timeFrame': 'Years 1 and 2', 'description': 'Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression.'}, {'measure': 'Percentage of Participants Who Experienced Surgery to Bone', 'timeFrame': 'Years 1 and 2', 'description': 'Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression.'}, {'measure': 'Percentage of Participants Who Experienced HCM', 'timeFrame': 'Years 1 and 2', 'description': 'HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter \\[mmol/L\\]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration.'}, {'measure': 'Skeletal Related Event (SRE) Rate', 'timeFrame': 'Years 1 and 2', 'description': 'The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.'}, {'measure': 'Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)', 'timeFrame': 'Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)', 'description': 'uNTx is a biomarker used to measure the rate of bone turnover found in urine.'}, {'measure': 'Time to Death', 'timeFrame': 'Up to 2 years', 'description': 'Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'zoledronic acid', 'skeletal complications', 'bone'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '26644410', 'type': 'RESULT', 'citation': 'Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, Hadala JT, Warsi G, Argonza-Aviles E, Ericson SG, Anderson KC. Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study. Clin Cancer Res. 2016 Mar 15;22(6):1378-84. doi: 10.1158/1078-0432.CCR-15-1864. Epub 2015 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of multiple myeloma\n* Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma\n* Stable renal function\n\nExclusion Criteria:\n\n* Known sensitivity to bisphosphonates\n* Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover\n* Current active dental problems\n* Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00622505', 'acronym': 'Z-MARK', 'briefTitle': 'Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'CZOL446EUS129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoledronic acid', 'description': 'Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \\[≥\\] 50 nanomoles per millimoles \\[nmol/mmol\\] creatinine or \\<50 nmol/mmol creatinine, respectively).', 'interventionNames': ['Drug: zoledronic acid']}], 'interventions': [{'name': 'zoledronic acid', 'type': 'DRUG', 'otherNames': ['Zometa'], 'description': 'Zoledronic acid concentrate (4 mg/5 milliliters \\[ml\\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.', 'armGroupLabels': ['Zoledronic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85222', 'city': 'Casa Grande', 'state': 'Arizona', 'country': 'United States', 'facility': 'TriValley Cancer Research and Treatment Center', 'geoPoint': {'lat': 32.8795, 'lon': -111.75735}}, {'zip': '91750', 'city': 'La Verne', 'state': 'California', 'country': 'United States', 'facility': 'Wilshire Oncology Medical Group', 'geoPoint': {'lat': 34.10084, 'lon': -117.76784}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center Outpatient Cancer Ctr. 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