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

NCT ID: NCT01016093

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Beta-Thalassemia; Bone Marrow Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Patients in this arm received zoledronic acid.

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

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.

Control

Patients in this arm received placebo as control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Zometa

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tehran University of Medical Sciences

Locations

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

HORCSCT-0601

Identifier Type: -

Identifier Source: org_study_id