Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: Results of a five-year, randomized, placebo-controlled trial

Jean Yves Reginster, Dieter Felsenberg, Steven Boonen, Adolfo Diez-Perez, Rene Rizzoli, Maria Luisa Brandi, Tim D. Spector, Kim Brixen, Stefan Goemaere, Catherine Cormier, A. Balogh, Pierre D. Delmas, Pierre J. Meunier

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Abstract

Objective. This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. Methods. A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. Results. Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. Conclusion. Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years.

Original languageEnglish
Pages (from-to)1687-1695
Number of pages9
JournalArthritis and Rheumatism
Volume58
Issue number6
DOIs
Publication statusPublished - Jun 2008

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strontium ranelate
Postmenopausal Osteoporosis
Randomized Controlled Trials
Placebos
Hip Fractures
Incidence
Therapeutics
Osteoporosis
Confidence Intervals
Osteoporotic Fractures
Femur Neck
Radiography
Bone Density
Spine

ASJC Scopus subject areas

  • Immunology
  • Rheumatology

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Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis : Results of a five-year, randomized, placebo-controlled trial. / Reginster, Jean Yves; Felsenberg, Dieter; Boonen, Steven; Diez-Perez, Adolfo; Rizzoli, Rene; Brandi, Maria Luisa; Spector, Tim D.; Brixen, Kim; Goemaere, Stefan; Cormier, Catherine; Balogh, A.; Delmas, Pierre D.; Meunier, Pierre J.

In: Arthritis and Rheumatism, Vol. 58, No. 6, 06.2008, p. 1687-1695.

Research output: Contribution to journalArticle

Reginster, JY, Felsenberg, D, Boonen, S, Diez-Perez, A, Rizzoli, R, Brandi, ML, Spector, TD, Brixen, K, Goemaere, S, Cormier, C, Balogh, A, Delmas, PD & Meunier, PJ 2008, 'Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: Results of a five-year, randomized, placebo-controlled trial', Arthritis and Rheumatism, vol. 58, no. 6, pp. 1687-1695. https://doi.org/10.1002/art.23461
Reginster, Jean Yves ; Felsenberg, Dieter ; Boonen, Steven ; Diez-Perez, Adolfo ; Rizzoli, Rene ; Brandi, Maria Luisa ; Spector, Tim D. ; Brixen, Kim ; Goemaere, Stefan ; Cormier, Catherine ; Balogh, A. ; Delmas, Pierre D. ; Meunier, Pierre J. / Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis : Results of a five-year, randomized, placebo-controlled trial. In: Arthritis and Rheumatism. 2008 ; Vol. 58, No. 6. pp. 1687-1695.
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abstract = "Objective. This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. Methods. A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. Results. Of the 5,091 patients, 2,714 (53{\%}) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15{\%} in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95{\%} confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43{\%} (relative risk 0.57 [95{\%} confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24{\%} (relative risk 0.76 [95{\%} CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. Conclusion. Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years.",
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T1 - Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis

T2 - Results of a five-year, randomized, placebo-controlled trial

AU - Reginster, Jean Yves

AU - Felsenberg, Dieter

AU - Boonen, Steven

AU - Diez-Perez, Adolfo

AU - Rizzoli, Rene

AU - Brandi, Maria Luisa

AU - Spector, Tim D.

AU - Brixen, Kim

AU - Goemaere, Stefan

AU - Cormier, Catherine

AU - Balogh, A.

AU - Delmas, Pierre D.

AU - Meunier, Pierre J.

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N2 - Objective. This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. Methods. A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. Results. Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. Conclusion. Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years.

AB - Objective. This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial. Methods. A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method. Results. Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings. Conclusion. Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years.

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