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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

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)