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Open Access 01-03-2012 | Original Article

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

Authors: J-Y. Reginster, J-M. Kaufman, S. Goemaere, J. P. Devogelaer, C. L. Benhamou, D. Felsenberg, M. Diaz-Curiel, M-L. Brandi, J. Badurski, J. Wark, A. Balogh, O. Bruyère, C. Roux

Published in: Osteoporosis International | Issue 3/2012

Abstract

Summary

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® 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.

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Title: Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis
Authors: J-Y. Reginster
J-M. Kaufman
S. Goemaere
J. P. Devogelaer
C. L. Benhamou
D. Felsenberg
M. Diaz-Curiel
M-L. Brandi
J. Badurski
J. Wark
A. Balogh
O. Bruyère
C. Roux
Publication date: 01-03-2012
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 3/2012
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-011-1847-z

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Summary

Introduction

Methods

Results

Conclusions

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Springer Medicine

Abstract

Summary

Introduction

Methods

Results

Conclusions

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