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

Primary Purpose

Beta-Thalassemia, Bone Marrow Transplantation

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zoledronic acid
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Beta-Thalassemia focused on measuring Thalassemia, BMT, HSCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hematology-Oncology & SCT Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Patients in this arm received zoledronic acid.

Patients in this arm received placebo as control group

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2009
Last Updated
July 25, 2011
Sponsor
Tehran University of Medical Sciences
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01016093
Brief Title
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
Official Title
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients: A Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta-Thalassemia, Bone Marrow Transplantation
Keywords
Thalassemia, BMT, HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in this arm received zoledronic acid.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients in this arm received placebo as control group
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To describe the percent change in total hip BMD at 12 months in the two study arms.
Time Frame
1 year
Title
To compare the changes in bone turn over markers at 3, 6, and 12 months in the two treatment arms.
Time Frame
1 year
Title
To describe the incidence rate of all clinical fractures at 1 year in the two study arms.
Time Frame
1 year
Title
To describe the general safety of zoledronic acid.
Time Frame
1 year
Title
To describe the percent change in lumbar spine (L1 to L4) BMD and total hip BMD at 6 months when available.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Hematology-Oncology & SCT Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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