Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-29 @ 10:04 PM
Study NCT ID:
NCT00639392
Status:
WITHDRAWN
Last Update Posted:
2011-11-11
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Ended early due to inability to identify eligible subjects', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-10', 'studyFirstSubmitDate': '2008-03-14', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.', 'timeFrame': 'Within 2 weeks of study drug administration and then every month for approximately 1 year'}], 'secondaryOutcomes': [{'measure': 'The specific purposes of this study are to learn if Zoledronic Acid has serious side effects for subjects with sickle cell disease and to study the effects of Zoledronic acid in subjects with sickle cell disease.', 'timeFrame': 'Two weeks after study drug administration and then every month for approximately 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sickle cell disease'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Male or female with sickle cell disease\n* Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months\n* Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo\n\nExclusion Criteria:\n\n* Calculated creatinine clearance less than 60 mL/min\n* Current active dental problems\n* Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants)\n* History of cirrhosis or chronic symptomatic liver disease; acute liver disease\n* History of aspirin-induced asthma\n* History of allergy to zoledronic acid or similar chemical-entities\n* Pregnant or nursing\n* No prior bisphosphonate use\n* Receipt of an investigational drug within 30 days'}, 'identificationModule': {'nctId': 'NCT00639392', 'briefTitle': 'Phase 1 Study of Zoledronic Acid in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Phase 1 Study of Zoledronic Acid in Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'VCU-PT101439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive Zolendronic Acid are 2 out of 3.', 'interventionNames': ['Drug: Zoledronic Acid']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.', 'armGroupLabels': ['2']}, {'name': 'Zoledronic Acid', 'type': 'DRUG', 'description': 'Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'John D Roberts, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}