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

NCT01016093 | Unknown Phase 2 DMC

• 1 other identifier: HORCSCT-0601
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Thalassemia; BMT; HSCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in this arm received zoledronic acid.

Drug: Zoledronic acid

Control

PLACEBO COMPARATOR

Patients in this arm received placebo as control group

Drug: Placebo

Interventions

Zoledronic acid 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.

Also known as: Zometa

Intervention

Placebo DRUG

Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Novartis: collaborator

Study Sites (1)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

beta-Thalassemia; Thalassemia

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

IR (1)