Article (Scientific journals)
Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
Reginster, Jean-Yves; Kaufman, J. M.; Goemaere, S. et al.
2012In Osteoporosis International, 23, p. 1115-1122
Peer Reviewed verified by ORBi
 

Files


Full Text
Maintenance of antifracture efficacy over 10 years.pdf
Publisher postprint (265.79 kB)
Request a copy

All documents in ORBi are protected by a user license.

Send to



Details



Abstract :
[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.
Disciplines :
General & internal medicine
Author, co-author :
Reginster, Jean-Yves  ;  Université de Liège - ULiège > 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  ;  Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Roux, C.
More authors (3 more) Less
Language :
English
Title :
Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
Publication date :
2012
Journal title :
Osteoporosis International
ISSN :
0937-941X
eISSN :
1433-2965
Publisher :
Springer Science & Business Media B.V., Godalming, United Kingdom
Volume :
23
Pages :
1115-1122
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 12 January 2012

Statistics


Number of views
56 (8 by ULiège)
Number of downloads
3 (3 by ULiège)

Scopus citations®
 
100
Scopus citations®
without self-citations
85
OpenCitations
 
80

Bibliography


Similar publications



Contact ORBi