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

Beta-Thalassemia Clinical Trial

Official title:

Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01016093
• Other study ID #: HORCSCT-0601
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: November 17, 2009
• Last updated: July 25, 2011
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Beta-Thalassemia
• Bone Marrow Transplantation
• Thalassemia

Intervention

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.
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology-Oncology & SCT Research Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Novartis

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To describe the percent change in total hip BMD at 12 months in the two study arms.		1 year	No
Secondary	To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms.		1 year	No
Secondary	To describe the incidence rate of all clinical fractures at 1 year in the two study arms.		1 year	No
Secondary	To describe the general safety of zoledronic acid.		1 year	No
Secondary	To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available.		1 year	No

External Links

•   Hematology-Oncology and Stem Cell Transplantation Research Center