title: Long-term fracture rates seen with continued ibandronate treatment: pooled analysis of DIVA and MOBILE long-term extension studies.
abstract: Ibandronate reduces the risk of vertebral and non-vertebral fractures versus placebo in postmenopausal women with osteoporosis. This analysis, in which fractures were reported as safety events, showed that long-term use of ibandronate was associated with low fracture rates over 5 years of treatment.
  
  
  BACKGROUND
  A previous post-hoc meta-analysis of 2-3 year studies found that ibandronate regimens with annual cumulative exposure (ACE) of ≥10.8 mg reduced the risk of vertebral and nonvertebral fractures (NVFs) versus placebo in postmenopausal women. This post-hoc analysis used individual patient data from the 2-year monthly oral ibandronate in ladies (MOBILE) and dosing intravenous administration (DIVA) studies, including the 3-year long-term extensions (LTEs), to assess fracture risk in patients treated with ibandronate for 5 years.
  
  
  METHODS
  Patients treated for 2 years in MOBILE with monthly oral ibandronate 150 mg (n = 176) and in DIVA with IV ibandronate every 2 months 2 mg (n = 253) or quarterly 3 mg (n = 263) who continued on the same regimens for 3 additional years in the LTEs were included. Three-year placebo data (n = 1,924) were obtained from the ibandronate osteoporosis vertebral fracture trial in North America and Europe (BONE) and IV Fracture Prevention trials. The primary endpoint was clinical fracture rate; clinical fracture data were collected as adverse events. Time to fracture was analyzed using Kaplan-Meier and statistical analysis was conducted using the log-rank test. All clinical fractures included all NVFs and symptomatic vertebral fractures.
  
  
  RESULTS
  For ibandronate regimens with ACE ≥10.8 mg, time to fracture was significantly longer for all clinical fractures, NVFs, and clinical vertebral fractures versus placebo (P = 0.005). For all fracture types, the rate of fracture appeared stable during the 5-year treatment period.
  
  
  CONCLUSIONS
  In women with postmenopausal osteoporosis, continuous treatment with ibandronate over 5 years results in low sustained clinical fracture rate.
authors.affiliation: Colorado Center for Bone Research, 3190 S Wadsworth Blvd, Lakewood, CO, 80227, 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: S
authors.initials: S
authors.lastname: Harris
authors.forename: S
authors.initials: S
authors.lastname: Silverman
authors.forename: D
authors.initials: D
authors.lastname: Felsenberg
authors.forename: J
authors.initials: J
authors.lastname: Reginster
authors.forename: B-M
authors.initials: BM
authors.lastname: Day
authors.forename: C
authors.initials: C
authors.lastname: Barr
authors.forename: D
authors.initials: D
authors.lastname: Masanauskaite
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004164:Diphosphonates / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000453:epidemiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control; D014481:United States / Q000453:epidemiology
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid