Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Status:
Completed
Trial end date:
2017-04-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Roche Pharma AG
Treatments:
Calcium, Dietary Diphosphonates Ergocalciferols Ibandronic Acid Vitamin D Vitamins