A randomized controlled trial of ibandronate for the prevention of bone loss following allogeneic stem cell transplantation.

Abstract

7029 Background: Bone mineral density (BMD) loss occurs rapidly within the first year following allogeneic hematopoietic stem cell transplantation (alloHCT), which can lead to fractures. Nonpharmacologic prophylaxis measures are inadequate in preventing bone loss following alloHCT and the effect of ibandronate has not been evaluated. Methods: We performed a phase 3 single-center open-label randomized controlled trial of intravenous ibandronate to prevent BMD loss in adult recipients of alloHCT at The University of Texas MD Anderson Cancer Center. The treatment group received 3 mg of intravenous ibandronate over 15–30 seconds starting within 45 days of alloHCT and at 3, 6, and 9 months after alloHCT. All patients received daily calcium (500 mg) and daily vitamin D (400 IU) oral supplements twice daily for 12 months. We compared changes in BMD in the lumbar spine, femoral neck, and total hip at 6 and 12 months following alloHCT relative to baseline between treatment and control groups. Results: Of 414 patie...