Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-31 @ 7:08 AM
Study NCT ID:
NCT00099203
Status:
TERMINATED
Last Update Posted:
2017-08-16
First Post:
2004-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077557', 'term': 'Ibandronic Acid'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2004-12-10', 'studyFirstSubmitQcDate': '2004-12-09', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, as measured by Brief Pain Inventory and analgesic use', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'Performance score and QoL measures', 'timeFrame': 'Week 24'}, {'measure': 'AEs and laboratory parameters', 'timeFrame': 'Throughout study'}, {'measure': 'Opioid side effects', 'timeFrame': 'Throughout study'}, {'measure': 'Skeletal-related events', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Pain', 'Bone Neoplasm', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with malignant bone disease;\n* patients with moderate to severe pain.\n\nExclusion Criteria:\n\n* patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;\n* patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;\n* untreated esophagitis or gastric ulcers;\n* recent or pre-scheduled radiotherapy to bone;\n* patients who are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00099203', 'briefTitle': 'A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain', 'orgStudyIdInfo': {'id': 'BO18040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ibandronate [Bondronat]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: zoledronic acid']}], 'interventions': [{'name': 'ibandronate [Bondronat]', 'type': 'DRUG', 'description': '6mg iv on days 1-3, and every 3-4 weeks', 'armGroupLabels': ['1']}, {'name': 'zoledronic acid', 'type': 'DRUG', 'description': '4mg iv on day 1 and every 3-4 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, 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