Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
Phase 2
- Conditions
- Beta-ThalassemiaBone Marrow Transplantation
- Interventions
- Drug: Placebo
- Registration Number
- NCT01016093
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo Patients in this arm received placebo as control group Intervention Zoledronic acid Patients in this arm received zoledronic acid.
- Primary Outcome Measures
Name Time Method 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. 1 year
- Secondary Outcome Measures
Name Time Method To describe the percent change in total hip BMD at 12 months in the two study arms. 1 year To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms. 1 year To describe the incidence rate of all clinical fractures at 1 year in the two study arms. 1 year To describe the general safety of zoledronic acid. 1 year To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available. 1 year
Trial Locations
- Locations (1)
Hematology-Oncology & SCT Research Center
🇮🇷Tehran, Iran, Islamic Republic of