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Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Novartis
Information provided by:
Tehran University of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Beta-Thalassemia Bone Marrow Transplantation Drug: Zoledronic acid Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
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
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To describe the percent change in total hip BMD at 12 months in the two study arms. [ Time Frame: 1 year ]
  2. To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms. [ Time Frame: 1 year ]
  3. To describe the incidence rate of all clinical fractures at 1 year in the two study arms. [ Time Frame: 1 year ]
  4. To describe the general safety of zoledronic acid. [ Time Frame: 1 year ]
  5. 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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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


Locations
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Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Novartis
More Information
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Responsible Party: Mahdi Jalili MD / Hematology-Oncology and SCT Research Center, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01016093    
Other Study ID Numbers: HORCSCT-0601
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Keywords provided by Tehran University of Medical Sciences:
Thalassemia
BMT
HSCT
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
 Hemoglobinopathies
Genetic Diseases, Inborn
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs