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See detailEfficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial.
Reginster, Jean-Yves ULg; Badurski, J; Bellamy, N et al

in Annals of the Rheumatic Diseases (2013), 72(2), 179-86

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its ... [more ▼]

BACKGROUND: Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis. METHODS: Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5-5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372). RESULTS: The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56) mm; 2 g/day: -0.27 (SD 0.63) mm; placebo: -0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. CONCLUSIONS: Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day. [less ▲]

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See detailStructure modifying effects of strontium ranelate in knee osteoarthritis
Reginster, Jean-Yves ULg; Chapurlat, R; Christiaensen, C et al

in Osteoporosis International (2012, March), 23(S2), 58-59

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See detailStrontium ranelate reduces the number of radiological or radioclinical progressors in patients with primary knee osteoarthritis
Reginster, Jean-Yves ULg; Chapurlat, R; Christiansen, C et al

in Osteoporosis International (2012, March), 23(S2), 366-367

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See detailStrontium ranelate in knee osteoarthritis trial (SEKOIA) : a structural and symptomatic efficacy
Reginster, Jean-Yves ULg; Chapurlat, R; Christiansen, C et al

in Arthritis and Rheumatism (2012), 64(S10), 681

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See detailEfficacy and safety of strontium ranelate in the treatment of knee osteoarthritis : a randomized, double-blind, placebo-controlled international trial
Cooper, C; Chapurlat, R; Christiansen, C et al

in Annals of the Rheumatic Diseases (2012), 71(3), 693

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See detailMaintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.
Reginster, Jean-Yves ULg; Kaufman, J. M.; Goemaere, S. et al

in Osteoporosis International (2012), 23

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 ... [more ▼]

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. [less ▲]

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See detailEfficacy and safety of strontium ranelate in the treatment of knee ostoarthritis : a randomized, double-blind, placebo-controlled international trial
Reginster, Jean-Yves ULg; Chapurlat, R.; Christiansen, C. et al

in Osteoporosis International (2011), 22(S5), 742-743

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See detailRanélate de strontium : efficacité à long terme sur 10 ans chez les femmes ménopausées ostéoporotiques
Reginster, Jean-Yves ULg; Kaufman, Jean-Marc; Goemaere, S. et al

in Revue du Rhumatisme (2010, November), 77(Suppl.3), 99-100

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See detailEffects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis.
Meunier, Pierre; Roux, C.; Ortolani, S. et al

in Osteoporosis International (2009), 20

Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33 ... [more ▼]

Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33% over 4 years, confirming the role of strontium ranelate as an effective long-term treatment in osteoporosis. INTRODUCTION: Osteoporotic vertebral fractures are associated with increased mortality, morbidity, and loss of quality-of-life (QoL). Strontium ranelate (2 g/day) was shown to prevent bone loss, increase bone strength, and reduce vertebral and peripheral fractures. The preplanned aim of this study was to evaluate long-term efficacy and safety of strontium ranelate. METHODS: A total of 1,649 postmenopausal osteoporotic women were randomized to strontium ranelate or placebo for 4 years, followed by a 1-year treatment-switch period for half of the patients. Primary efficacy criterion was incidence of patients with new vertebral fractures over 4 years. Lumbar bone mineral density (BMD) and QoL were also evaluated. RESULTS: Over 4 years, risk of vertebral fracture was reduced by 33% with strontium ranelate (risk reduction = 0.67, p < 0.001). Among patients with two or more prevalent vertebral fractures, risk reduction was 36% (p < 0.001). QoL, assessed by the QUALIOST(R), was significantly better (p = 0.025), and patients without back pain were greater (p = 0.005) with strontium ranelate than placebo over 4 years. Lumbar BMD increased over 5 years in patients who continued with strontium ranelate, while it decreased in patients who switched to placebo. Emergent adverse events were similar between groups. CONCLUSION: In this 4- and 5-year study, strontium ranelate is an effective and safe treatment for long-term treatment of osteoporosis in postmenopausal women. [less ▲]

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See detailRelationship between Change in Femoral Neck Bone Mineral Density and Hip Fracture Incidence During Treatment with Strontium Ranelate
Bruyère, Olivier ULg; Roux, Christian; Badurski, J. et al

in Current Medical Research & Opinion (2007), 23(12), 3041-5

OBJECTIVE: Strontium ranelate (SR) increases bone mineral density (BMD) in postmenopausal osteoporotic women and reduces vertebral and non-vertebral fracture incidence. Hip fracture reduction has also ... [more ▼]

OBJECTIVE: Strontium ranelate (SR) increases bone mineral density (BMD) in postmenopausal osteoporotic women and reduces vertebral and non-vertebral fracture incidence. Hip fracture reduction has also been observed during 3-year treatment with SR in osteoporotic women at high risk of hip fracture. The objective of this study is to analyse the association between BMD changes and hip fracture incidence during treatment with SR. MATERIAL AND METHODS: In this post-hoc analysis, 465 women aged over 74 years with low BMD at the femoral neck (T-score < or = -2.4 according to NHANES normative values) were selected from the population of a recently published study (the Treatment of Peripheral Osteoporosis Study - TROPOS). BMD was assessed at the femoral neck at baseline and after a follow-up of 3 years. Hip fractures were reported by study investigators. RESULTS: After adjusting for age, body mass index, femoral neck BMD at baseline and number of prevalent vertebral fractures, we found that for each 1% increase in femoral neck BMD observed after 3 years, the risk to experience a hip fracture after 3 years decreased by 7% (95% CI: 1-14%) (p = 0.04). In patients experiencing a hip fracture over 3 years of treatment with SR, femoral neck BMD increased by (mean [SE]) 3.41 (1.02)% compared to 7.23 (0.81)% in patients without hip fracture (p = 0.02). CONCLUSION: In this post-hoc analysis of women undergoing 3 years of SR treatment, an increase in femoral neck BMD is associated with a decrease in hip fracture incidence. [less ▲]

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See detailstrontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women without prevalent vertebral fracture
Reginster, Jean-Yves ULg; Rizzoli, René; Balogh, A. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 53

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See detailStrontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women without prevalent vertebral fracture
Reginster, Jean-Yves ULg; Rizzoli, R.; Balogh, A. et al

in Calcified Tissue International (2004), 74(S1), 83

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See detailStrontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women without prevalent vertebral fracture
Reginster, Jean-Yves ULg; Balogh, A.; Badurski, J. et al

in Osteoporosis International (2003, November), 14(Suppl. 7), 7-8

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See detailOptimizing patient adherence and persistence in strontium ranelate phase 3 program using a short term run-in study
Reginster, Jean-Yves ULg; Spector, Tim; Badurski, J. et al

in Osteoporosis International (2002, November), 13(Suppl.3), 35-36

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See detailA short-term run-in study can significantly contribute to increasing the quality of long-term osteoporosis trials. The strontium-ranelate phase 3 program
Reginster, Jean-Yves ULg; Spector, T.; Badurski, J. et al

in Osteoporosis International (2002), 13(S1), 30

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