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Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients

NCT00824993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2018-09-13

Study results available
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Summary

The goal of this clinical research study is to see if ibandronate can help to slow the rate of bone loss that may occur in patients who have received a bone marrow transplant for blood cancer.

This study plans to address the following hypotheses:

1. The addition of Ibandronate initiated immediately after the transplantation will prevent bone loss in patients undergoing allogenic bone marrow transplantation (BMT) with underlying hematologic malignancies or hematologic disorders.
2. BMT patients who require prolonged steroid and other immunosuppressive treatment for Graft versus Host Diseases(GVHD) have a higher rate of bone loss, which can be prevented or attenuated by Ibandronate.

Specific objectives to test these hypotheses are:

1. Primary Objective:

1\. To prospectively compare the bone mineral density changes of lumbar spine, femoral neck and total hip between patients randomly assigned to ibandronate and control group over 12 months post bone marrow transplantation at the University of Texas MD Anderson Cancer Center.
2. Secondary Objectives:

1. To measure and compare the accumulated level of steroid used in both treatment and control groups.
2. To collect and compare the level of serum C-terminal telopeptide (CTX) in both treatment and control groups to monitor the bone turnover rate for the duration of the study.
3. To conduct a cost-effectiveness analysis of participating patients for both outcomes on bone mineral density (measured data) and skeletal-related events (modeled data).
4. To record incidence of bone fractures and the graft rate in both treatment and control groups.

Conditions

Interventions

DRUG

Ibandronate

Infusion of 3 mg by vein over 15 to 30 seconds for 4 doses at 3-6 weeks after transplant, and at Months 3, 6, and 9 after the transplant.

DRUG

Vitamin Supplements

Calcium 500 mg by mouth everyday for 12 months Vitamin D 400 units by mouth 2 times a day for 12 months

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Huifang Lu, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-09
Primary Completion
2017-04-07
Completion
2017-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824993 on ClinicalTrials.gov