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Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis

(2012) OSTEOPOROSIS INTERNATIONAL. 23(3). p.1115-1122
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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. 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. 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 FRAXA (R) scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAXA (R)-matched placebo group identified in the TROPOS placebo arm. 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 FRAXA (R)-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. 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.
Keywords
CONTINUING OUTCOMES RELEVANT, Strontium ranelate, Long-term treatment, Osteoporotic fracture, BMD, EXTENSION, PROBABILITY, FRACTURE INTERVENTION TRIAL, VERTEBRAL FRACTURE, RANDOMIZED-TRIAL, WOMEN, RISK, LONG, ALENDRONATE

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MLA
Reginster, J. Y., et al. “Maintenance of Antifracture Efficacy over 10 Years with Strontium Ranelate in Postmenopausal Osteoporosis.” OSTEOPOROSIS INTERNATIONAL, vol. 23, no. 3, 2012, pp. 1115–22, doi:10.1007/s00198-011-1847-z.
APA
Reginster, J.-Y., Kaufman, J., Goemaere, S., Devogelaer, J., Benhamou, C., Felsenberg, D., … Roux, C. (2012). Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis. OSTEOPOROSIS INTERNATIONAL, 23(3), 1115–1122. https://doi.org/10.1007/s00198-011-1847-z
Chicago author-date
Reginster, J-Y, Jean Kaufman, Stefan Goemaere, JP Devogelaer, CL Benhamou, D Felsenberg, M Diaz-Curiel, et al. 2012. “Maintenance of Antifracture Efficacy over 10 Years with Strontium Ranelate in Postmenopausal Osteoporosis.” OSTEOPOROSIS INTERNATIONAL 23 (3): 1115–22. https://doi.org/10.1007/s00198-011-1847-z.
Chicago author-date (all authors)
Reginster, J-Y, Jean Kaufman, Stefan Goemaere, JP Devogelaer, CL Benhamou, D Felsenberg, M Diaz-Curiel, M-L Brandi, J Badurski, J Wark, A Balogh, O Bruyère, and C Roux. 2012. “Maintenance of Antifracture Efficacy over 10 Years with Strontium Ranelate in Postmenopausal Osteoporosis.” OSTEOPOROSIS INTERNATIONAL 23 (3): 1115–1122. doi:10.1007/s00198-011-1847-z.
Vancouver
1.
Reginster J-Y, Kaufman J, Goemaere S, Devogelaer J, Benhamou C, Felsenberg D, et al. Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis. OSTEOPOROSIS INTERNATIONAL. 2012;23(3):1115–22.
IEEE
[1]
J.-Y. Reginster et al., “Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis,” OSTEOPOROSIS INTERNATIONAL, vol. 23, no. 3, pp. 1115–1122, 2012.
@article{3091367,
  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. 
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. 
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 FRAXA (R) scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAXA (R)-matched placebo group identified in the TROPOS placebo arm. 
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 FRAXA (R)-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. 
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.}},
  author       = {{Reginster, J-Y and Kaufman, Jean and Goemaere, Stefan and Devogelaer, JP and Benhamou, CL and Felsenberg, D and Diaz-Curiel, M and Brandi, M-L and Badurski, J and Wark, J and Balogh, A and Bruyère, O and Roux, C}},
  issn         = {{0937-941X}},
  journal      = {{OSTEOPOROSIS INTERNATIONAL}},
  keywords     = {{CONTINUING OUTCOMES RELEVANT,Strontium ranelate,Long-term treatment,Osteoporotic fracture,BMD,EXTENSION,PROBABILITY,FRACTURE INTERVENTION TRIAL,VERTEBRAL FRACTURE,RANDOMIZED-TRIAL,WOMEN,RISK,LONG,ALENDRONATE}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{1115--1122}},
  title        = {{Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis}},
  url          = {{http://doi.org/10.1007/s00198-011-1847-z}},
  volume       = {{23}},
  year         = {{2012}},
}

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