This trial is active, not recruiting.

Conditions beta-thalassemia, bone marrow transplantation
Treatments zoledronic acid, placebo
Phase phase 2/phase 3
Sponsor Tehran University of Medical Sciences
Collaborator Novartis
Start date November 2009
End date November 2011
Trial size 50 participants
Trial identifier NCT01016093, HORCSCT-0601


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Patients in this arm received zoledronic acid.
zoledronic acid Zometa
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 Comparator)
Patients in this arm received placebo as control group

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.