Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
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|ClinicalTrials.gov Identifier: NCT01016093|
Recruitment Status : Unknown
Verified July 2011 by Tehran University of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : November 18, 2009
Last Update Posted : July 26, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Beta-Thalassemia Bone Marrow Transplantation||Drug: Zoledronic acid Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||December 2011|
Patients in this arm received zoledronic acid.
Drug: Zoledronic acid
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.
Other Name: Zometa
Placebo Comparator: Control
Patients in this arm received placebo as control group
- 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. [ Time Frame: 1 year ]
- To describe the percent change in total hip BMD at 12 months in the two study arms. [ Time Frame: 1 year ]
- To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms. [ Time Frame: 1 year ]
- To describe the incidence rate of all clinical fractures at 1 year in the two study arms. [ Time Frame: 1 year ]
- To describe the general safety of zoledronic acid. [ Time Frame: 1 year ]
- To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available. [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Signed written informed consent.
- Patients must be 18 years old and over.
- Diagnosed with beta-thalassemia major
- Scheduled for allogenic bone marrow transplantation
- The date of randomization must be no more than 1 week after BMT.
- Patients must be accessible for follow-up.
- Life expectancy of at least 12 months from randomization.
- Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip.
- Patients with a history of fracture with low-density or no associated trauma.
- Osteoporotic patients with T-score <= -2.5
- Previous treatment with a bisphosphonate.
- 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.
- Pregnancy and lactation.
- Women of childbearing potential not on a medically recognized form of contraception.
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study.
- Subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens.
- Known hypersensitivity to zoledronic acid or bisphosphonates.
- 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).
- Serious intercurrent illness
- History of metabolic bone diseases
- History of corticosteroid treatment for other causes
- History of antiepileptic drug treatment
- History or surgery at the lumbosacral spine, with or without implantable devices.
- Any disease of the spine that would preclude the proper acquisition of a lumbar spine DXA.
- Mental illness that precludes the patient from giving informed consent.
- 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.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016093
|Iran, Islamic Republic of|
|Hematology-Oncology & SCT Research Center|
|Tehran, Iran, Islamic Republic of, 14114|
|Responsible Party:||Mahdi Jalili MD / Hematology-Oncology and SCT Research Center, Tehran University of Medical Sciences|
|Other Study ID Numbers:||
|First Posted:||November 18, 2009 Key Record Dates|
|Last Update Posted:||July 26, 2011|
|Last Verified:||July 2011|
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Bone Density Conservation Agents
Physiological Effects of Drugs