title: 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 1 mg/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 0.5 mg/month n = 376; ibandronate 1 mg/month n = 382; risedronate oral 2.5 mg/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 1 mg/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 1 mg/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 1 mg/month, and 9.5 and 9.4 %, respectively, with risedronate. Fracture incidence was consistently lower, but not significant, with ibandronate 1 mg/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.
authors.affiliation: Center for Gender Equality, Nagasaki University, Nagasaki, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Ito
authors.affiliation: Clinical Development Division, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Tobinai
authors.affiliation: Clinical Development Division, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
authors.forename: Seitaro
authors.initials: S
authors.lastname: Yoshida
authors.affiliation: Project and Lifecycle Management Unit, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan. hashimotojnk@chugai-pharm.co.jp.
authors.forename: Junko
authors.initials: J
authors.lastname: Hashimoto
authors.affiliation: National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D015519:Bone Density / Q000187:drug effects*; D004164:Diphosphonates / Q000008:administration & dosage*; D005260:Female; D005265:Femoral Neck Fractures / Q000453:epidemiology / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control; D005272:Femur Neck / Q000378:metabolism*; D006801:Humans; D000077557:Ibandronic Acid; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000378:metabolism; D000068296:Risedronic Acid / Q000008:administration & dosage; D016103:Spinal Fractures / Q000453:epidemiology / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control; D013131:Spine / Q000378:metabolism*
chemical_list: D004164:Diphosphonates; D000068296:Risedronic Acid; D000077557:Ibandronic Acid
keywords: BMD T score; Femoral neck; Ibandronate; MOVER study; Prevalent fracture