Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01016093
Status:
UNKNOWN
Last Update Posted:
2011-07-26
First Post:
2009-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}, {'id': 'D013789', 'term': 'Thalassemia'}], '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the percent change in the lumbar spine (L1 to L4) BMD, as measured by dual energy X-ray absorptiometry, at 12 months in patients with beta-thalassemia major undergoing allogenic BMT randomized to zoledronic acid versus placebo.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To describe the percent change in total hip BMD at 12 months in the two study arms.', 'timeFrame': '1 year'}, {'measure': 'To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms.', 'timeFrame': '1 year'}, {'measure': 'To describe the incidence rate of all clinical fractures at 1 year in the two study arms.', 'timeFrame': '1 year'}, {'measure': 'To describe the general safety of zoledronic acid.', 'timeFrame': '1 year'}, {'measure': 'To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thalassemia', 'BMT', 'HSCT'], 'conditions': ['Beta-Thalassemia', 'Bone Marrow Transplantation']}, 'descriptionModule': {'briefSummary': 'This is prospective randomized, double blind study designed to evaluate the use of zoledronic acid in the prevention prevention of bone loss post allogenic BMT done for beta-thalassemia major patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent.\n* Patients must be 18 years old and over.\n* Diagnosed with beta-thalassemia major\n* Scheduled for allogenic bone marrow transplantation\n* The date of randomization must be no more than 1 week after BMT.\n* Patients must be accessible for follow-up.\n* Life expectancy of at least 12 months from randomization.\n\nExclusion Criteria:\n\n* Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.\n* Patients with a history of fracture with low-density or no associated trauma.\n* Osteoporotic patients with T-score \\<= -2.5\n* Previous treatment with a bisphosphonate.\n* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 30 ml/minute or less.\n* Pregnancy and lactation.\n* Women of childbearing potential not on a medically recognized form of contraception.\n* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study.\n* Subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens.\n* Known hypersensitivity to zoledronic acid or bisphosphonates.\n* Patients with prior exposure to anabolic steroids, growth hormone, Parathyroid Hormone (PTH) or other drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate).\n* Serious intercurrent illness\n* History of metabolic bone diseases\n* History of corticosteroid treatment for other causes\n* History of antiepileptic drug treatment\n* History or surgery at the lumbosacral spine, with or without implantable devices.\n* Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.\n* Mental illness that precludes the patient from giving informed consent.\n* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.\n* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)'}, 'identificationModule': {'nctId': 'NCT01016093', 'briefTitle': 'Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'HORCSCT-0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients in this arm received zoledronic acid.', 'interventionNames': ['Drug: Zoledronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients in this arm received placebo as control group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'otherNames': ['Zometa'], 'description': 'Zoledronic acid 4 mg adjusted dose based on renal function IV 15-minute infusion every 3 months for a total of one year ( 4 doses ) beginning as soon as possible after randomization.', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14114', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Hematology-Oncology & SCT Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Mahdi Jalili MD / Hematology-Oncology and SCT Research Center', 'oldOrganization': 'Tehran University of Medical Sciences'}}}}