title: Higher response with bone mineral density increase with monthly injectable ibandronate 1 mg compared with oral risedronate in the MOVER study.
abstract: We examined response to bone mineral density (BMD) gains in the MOVER study following treatment with intravenous (IV) ibandronate 1 mg/month, and investigated the characteristics of a non-responder group. At 1 year, responder rates for patients with BMD increases >0 % were similar with IV ibandronate 0.5 or 1 mg/month and oral risedronate 2.5 mg/day. However, after 3 years, responder rates with BMD increases ≥3 % were highest with ibandronate 1 mg at all bone sites (>80 % at the lumbar spine [L2-L4] and >50 % at all femur sites, which was significantly higher than with risedronate). Non-responders were defined by BMD increases ≤3 % at L2-L4 or ≤0 % at total hip, and ≤50 % reduction in creatinine-corrected urinary collagen type 1 cross-linked C-telopeptide (uCTX) from baseline to 1 year. There were a small number of non-responders in the ibandronate 1 mg group: 3.3 % (10/299) with ≤0 % total hip BMD increase and ≤50 % uCTX reduction from baseline. These non-responders had lower 25-hydroxyvitamin D (25[OH]D) levels than responders, but no differences in kidney function, L2-L4 BMD or bone turnover marker baseline values. Throughout the study, non-responders failed to show any increases in BMD. Our analysis demonstrates significantly higher responder rates with IV ibandronate 1 mg/month than with risedronate at 3 years. A small number of non-responders in the ibandronate group had lower 25(OH)D baseline levels than responders, suggesting that 25(OH)D levels could be a useful indicator of BMD response to therapy.
authors.affiliation: Tamana Central Hospital, Kumamoto, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Project & Lifecycle Management Unit, Chugai Pharmaceutical Co. Ltd., Tokyo, Japan.
authors.forename: Masao
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Project & 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: 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: National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D024042:Collagen Type I / Q000652:urine; D003404:Creatinine / Q000652:urine; D004164:Diphosphonates / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005269:Femur / Q000378:metabolism; D006801:Humans; D000077557:Ibandronic Acid; D007677:Kidney Function Tests; D008159:Lumbar Vertebrae / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D010455:Peptides / Q000652:urine; D000068296:Risedronic Acid / Q000008:administration & dosage*; D016103:Spinal Fractures / Q000097:blood / Q000209:etiology / Q000517:prevention & control / Q000652:urine; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood
chemical_list: D024042:Collagen Type I; D004164:Diphosphonates; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D003404:Creatinine; D000068296:Risedronic Acid; D000077557:Ibandronic Acid
keywords: Ibandronate; Intravenous; MOVER study; Osteoporosis; Responders