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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01016093

Collaborator

Novartis (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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 Names: Zometa
Placebo Comparator: Control Patients in this arm received placebo as control group	Drug: Placebo Placebo

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 Names:

Zometa

Placebo Comparator: Control

Patients in this arm received placebo as control group

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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. [1 year]

Secondary Outcome Measures

To describe the percent change in total hip BMD at 12 months in the two study arms. [1 year]
To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms. [1 year]
To describe the incidence rate of all clinical fractures at 1 year in the two study arms. [1 year]
To describe the general safety of zoledronic acid. [1 year]
To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)