title: Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
abstract: In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term.
  
  
  BACKGROUND
  Strontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years.
  
  
  METHODS
  Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX® scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX®-matched placebo group identified in the TROPOS placebo arm.
  
  
  RESULTS
  The patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 ± 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX®-matched placebo group over 5 years (P < 0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years.
  
  
  CONCLUSIONS
  Long-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate.
authors: Department of Public Health and Health Economics, University of Liège, Liège, Belgium. jyreginster@ulg.ac.be
authors: J-Y
authors: JY
authors: Reginster
authors: J-M
authors: JM
authors: Kaufman
authors: S
authors: S
authors: Goemaere
authors: J P
authors: JP
authors: Devogelaer
authors: C L
authors: CL
authors: Benhamou
authors: D
authors: D
authors: Felsenberg
authors: M
authors: M
authors: Diaz-Curiel
authors: M-L
authors: ML
authors: Brandi
authors: J
authors: J
authors: Badurski
authors: J
authors: J
authors: Wark
authors: A
authors: A
authors: Balogh
authors: O
authors: O
authors: Bruyère
authors: C
authors: C
authors: Roux
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D005500:Follow-Up Studies; D006621:Hip Joint / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D009942:Organometallic Compounds; D013876:Thiophenes; C081587:strontium ranelate