Reference : Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopa...
Scientific journals : Article
Human health sciences : General & internal medicine
http://hdl.handle.net/2268/107713
Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
English
Reginster, Jean-Yves mailto [Université de Liège - ULg > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé]
Kaufman, J. M. [> > > >]
Goemaere, S. [> > > >]
Devogelaer, J. P. [> > > >]
Benhamou, C. L. [> > > >]
Felsenberg, D. [> > > >]
Diaz-Curiel, M. [> > > >]
Brandi, M. L. [> > > >]
Badurski, J. [> > > >]
Wark, J. [> > > >]
Balogh, A. [> > > >]
Bruyère, Olivier mailto [Université de Liège - ULg > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé]
Roux, C. [> > > >]
2012
Osteoporosis International
Springer Science & Business Media B.V.
23
1115-1122
Yes (verified by ORBi)
International
0937-941X
1433-2965
Godalming
United Kingdom
[en] 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. INTRODUCTION: 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(R) scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX(R)-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(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. 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.
http://hdl.handle.net/2268/107713
10.1007/s00198-011-1847-z

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