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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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.
Placebo
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, Iran
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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