Effect of monthly intravenous ibandronate injections on vertebral or non-vertebral fracture risk in Japanese patients with high-risk osteoporosis in the MOVER study.

Abstract

We examined the efficacy of intravenous (IV) ibandronate 1mg/month in patient subgroups in the phase III MOVER study. Here we present results of analyses on the incidence of fractures in patients with prevalent vertebral fractures (1 or≥2, and≥3) at screening and femoral neck (FN) bone mineral density (BMD) T scores≥-2.5 or<-2.5, and<-3.0 at baseline. The per-protocol set comprised 1134 patients (ibandronate 0.5mg/month n=376; ibandronate 1mg/month n=382; risedronate oral 2.5mg/day n=376). The incidence of vertebral fractures in patients with 1 or≥2 prevalent vertebral fractures was 11.2 and 20.4%, respectively, with ibandronate 1mg/month, and 12.6 and 22.1%, respectively, with risedronate. In patients with FN BMD T scores≥-2.5 or<-2.5, the vertebral fracture incidence was 13.7 and 16.4%, respectively, with ibandronate 1mg/month, and 17.3 and 19.1%, respectively, with risedronate. The incidence of non-vertebral fractures in patients with≥2 prevalent vertebral fractures or FN BMD T score<-2.5 was 7.6 and 7.6%, respectively, with ibandronate 1mg/month, and 9.5 and 9.4%, respectively, with risedronate. Fracture incidence was consistently lower, but not significant, with ibandronate 1mg/month than with risedronate in patients with≥2 prevalent vertebral fractures and FN BMD T score<-2.5. The efficacy of the fracture reduction of monthly IV ibandronate appears consistent and seemingly independent of the number of prevalent vertebral fractures or baseline BMD values.