Lymphoma Clinical Trial
Official title:
A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are
undergoing donor stem cell transplant.
PURPOSE: This randomized phase II trial is studying how well zoledronic acid works in
preventing osteoporosis in patients undergoing donor stem cell transplant.
OBJECTIVES:
Primary
- Evaluate whether prophylactic administration of zoledronic acid can reduce the severity
of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell
transplantation.
Secondary
- 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
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