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

Tehran University of Medical Sciences

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Beta-Thalassemia

Bone Marrow Transplantation

Treatments

Drug: Placebo

Drug: Zoledronic acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01016093

HORCSCT-0601

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)