Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00774020
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2008-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010001', 'term': 'Osteitis Deformans'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.', 'timeFrame': 'at the end of 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'The percent change from baseline in total Serum Alkaline Phosphatase (SAP).', 'timeFrame': 'at the end of 3 months and 6 months'}, {'measure': 'The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).', 'timeFrame': 'at the end of 3 months and 6 months'}]}, 'conditionsModule': {'keywords': ["Paget's Disease of Bone", 'Serum Alkaline Phosphatase'], 'conditions': ["Paget's Disease of Bone"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of PDB by radiological reports\n* Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)\n\nExclusion Criteria:\n\n* History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;\n* History of malignancy of any organ system\n* Severe liver or bladder disease;\n* Calculated creatinine clearance \\< 35 mL/min at baseline;\n* Hypocalcaemia;\n* Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;\n* Evidence of vitamin D deficiency.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00774020', 'briefTitle': "Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China", 'orgStudyIdInfo': {'id': 'CZOL446K2419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Zoledronic acid']}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'description': '5mg, i.v. single dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}