A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- Evaluate whether prophylactic administration of zoledronic acid can reduce the severity
of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell
- Determine the safety of zoledronic acid in these patients.
OUTLINE: This is a multicenter, open-label, prospective, randomized, controlled study.
Patients are stratified according to participating center and type of transplant
(myeloablative vs nonmyeloablative). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive oral cholecalciferol (vitamin D) and oral calcium
once a day for 12 months.
- Arm II (treatment): Patients receive vitamin D and calcium as in arm I. Patients also
receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem
cell transplantation and at 3 and 6 months after transplantation.
In both arms, treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean Change in Bone Mineral Density
Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months. This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline.
From Time of Transplant to 12 Months Post-Transplant
Linda J. Burns, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|