Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients

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.

Timeline

Start

2008-12-09

Primary completion

2017-04-07

Completion

2017-04-07

Drugs

Indications