title: Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study.
abstract: The long-term efficacy and safety of once-monthly ibandronate were studied in this extension to the 2-year Monthly Oral Ibandronate in Ladies (MOBILE) trial. Over 5 years, lumbar spine bone mineral density (BMD) increased from baseline with monthly ibandronate 150 mg (8.4%). Long-term monthly ibandronate is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.
  
  
  BACKGROUND
  Once-monthly therapy with ibandronate has been studied for up to 5 years in a long-term extension (LTE) to the 2 year MOBILE trial.
  
  
  METHODS
  This multicenter, double-blind extension study of monthly ibandronate involved postmenopausal women who had completed 2 years of the MOBILE core study, with ≥75% adherence. Patients were reallocated, or were randomized from daily therapy, to ibandronate 100 mg monthly or 150 mg monthly for a further 3 years.
  
  
  RESULTS
  A pooled intent-to-treat (ITT) analysis of 344 patients receiving monthly ibandronate from the core MOBILE baseline showed increases over 5 years in lumbar spine BMD (8.2% with 100 mg and 8.4% with 150 mg). Three-year data relative to MOBILE LTE baseline in the full ITT population of all 698 patients randomized or reallocated from MOBILE (including those previously on daily treatment) showed, on average, maintenance of proximal femur BMD gains achieved in the core 2-year study, with further small gains in lumbar spine BMD. In general, maintenance of efficacy was also indicated by markers of bone metabolism.
  
  
  CONCLUSIONS
  There were no tolerability concerns or new safety signals. Monthly treatment with ibandronate 100 and 150 mg is effective and well tolerated for up to 5 years in women with postmenopausal osteoporosis.
authors.affiliation: Colorado Center for Bone Research, Lakewood, CO, USA. millerccbr@aol.com
authors.forename: P D
authors.initials: PD
authors.lastname: Miller
authors.forename: R R
authors.initials: RR
authors.lastname: Recker
authors.forename: J-Y
authors.initials: JY
authors.lastname: Reginster
authors.forename: B J
authors.initials: BJ
authors.lastname: Riis
authors.forename: E
authors.initials: E
authors.lastname: Czerwinski
authors.forename: D
authors.initials: D
authors.lastname: Masanauskaite
authors.forename: A
authors.initials: A
authors.lastname: Kenwright
authors.forename: R
authors.initials: R
authors.lastname: Lorenc
authors.forename: J A
authors.initials: JA
authors.lastname: Stakkestad
authors.forename: P
authors.initials: P
authors.lastname: Lakatos
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000378:metabolism; D015519:Bone Density / Q000502:physiology; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016723:Bone Remodeling; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging; D006801:Humans; D000077557:Ibandronic Acid; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid