Clinical trial NCT01016093: Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
Official title: Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Beta-Thalassemia
Bone Marrow Transplantation
Keywords: Thalassemia
BMT
HSCT
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
References: