Long-term treatment of postmenopausal osteoporosis with strontium ranelate: Results at 8 years.Reginster, Jean-Yves ; Bruyère, Olivier ; et alin BONE (2009), 45 OBJECTIVES: Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This ... [more ▼] OBJECTIVES: Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This article describes the efficacy, safety, and tolerability of this agent over 8 years. METHODS: Postmenopausal osteoporotic women having participated in the 5-year efficacy trials SOTI and TROPOS were invited to enter a 3-year open-label extension study. The results presented here focus on patients who received strontium ranelate for 8 years. RESULTS: At the extension baseline, the population treated for 8 years (n=879; 79.1+/-5.6 years) had femoral neck T-score of -2.61+/-0.71. The cumulative incidences of new vertebral and nonvertebral fractures (13.7% and 12.0%, respectively) over years 6 to 8 were non-statistically different from the cumulative incidences in the first 3 years of the original studies (11.5% and 9.6%). Lumbar spine, femoral neck, and total hip bone mineral density (BMD) increased throughout the 8-year period. Annual relative change in BMD was significant at every visit, except the 8-year visit for femoral neck and total hip BMD. Strontium ranelate was safe and well tolerated over 8 years. CONCLUSIONS: Long-term treatment with strontium ranelate 2 g/day in postmenopausal osteoporotic women leads to continued increases in BMD at all sites. The data also provide some evidence for a sustained antifracture efficacy. [less ▲] Detailed reference viewed: 79 (31 ULg) Strontium ranelate : long-term efficacy over 8 years in postmenopausal osteoporotic womenReginster, Jean-Yves ; ; et alin Arthritis and Rheumatism (2008, October), 58 Detailed reference viewed: 13 (5 ULg) Strontium ranelate: 8 years efficacy on vertebral and nonvertebral fractures in postmenopausal osteoporotic womenReginster, Jean-Yves ; ; et alin Osteoporosis International (2008, April), 19(Suppl.1), 131-132 Detailed reference viewed: 10 (1 ULg) Le ranélate de strontium maintient son efficacité sur 8 ans chez les femmes ménopausées ostéoporotiquesReginster, Jean-Yves ; ; et alin Revue du Rhumatisme (2008), 75 Detailed reference viewed: 5 (1 ULg) Strontium ranelate reduces the risk of vertebral fracture in patients with osteopenia; ; Reginster, Jean-Yves et alin Osteoporosis International (2006, June), 17(Suppl.2), 85 Detailed reference viewed: 3 (1 ULg) Vertebral fracture risk reduction with strontium ranelate in women with post-menopausal osteoporosis is independent of baseline risk factors; Reginster, Jean-Yves ; et alin Osteoporosis International (2006, June), 17(Suppl.2), 92 Detailed reference viewed: 2 (0 ULg) Strontium ranelate reduces the risk of vertebral fracture in patients with osteopenia; ; Reginster, Jean-Yves et alin Osteoporosis International (2006, May), 17(Suppl. 2), 209 Detailed reference viewed: 7 (4 ULg) Vertebral fracture risk reduction with strontium ranelate in women with postmenopausal osteoporosis is independent of baseline risk factors; Reginster, Jean-Yves ; et alin Journal of Bone and Mineral Research (2006), 21(4), 536-542 Strontium ranelate (2 g/day) was studied in 5082 postmenopausal women. A reduction in incident vertebral fracture risk by 40% was shown after 3 years. This effect was independent of age, initial BMD, and ... [more ▼] Strontium ranelate (2 g/day) was studied in 5082 postmenopausal women. A reduction in incident vertebral fracture risk by 40% was shown after 3 years. This effect was independent of age, initial BMD, and prevalent vertebral fractures. Introduction: Strontium ranelate is an orally active treatment able to decrease the risk of vertebral and hip fractures in osteoporotic postmenopausal women. The aim of this study was to assess the efficacy of strontium ranelate according to the main determinants of vertebral fracture risk: age, baseline BMD, prevalent fractures, family history of osteoporosis, baseline BMI, and addiction to smoking. Materials and Methods: We pooled data of two large multinational randomized double-blind studies with a population of 5082 (2536 receiving strontium ranelate 2 g/day and 2546 receiving a placebo), 74 years of age on average, and a 3-year follow-up. An intention-to-treat principle was used, as well as a Cox model for comparison and relative risks. Results: The treatment decreased the risk of both vertebral (relative risk [RR] = 0.60 [0.53-0.69] p < 0.001) and nonvertebral (RR = 0.85 [0.74-0.99] p = 0.03) fractures. The decrease in risk of vertebral fractures was 37% (p = 0.003) in women <70 years, 42% (p < 0.001.) for those 70-80 years of age, and 32% (P = 0.013) for those >= 80 years. The RR of vertebral fracture was 0.28 (0.07-0.99) in osteopenic and 0.61. (0.53-0.70) in osteoporotic women, and baseline BMD was not a determinant of efficacy. The incidence of vertebral fractures in the placebo group increased with the number of prevalent vertebral fractures, but this was not a determinant of the effect of strontium ranelate. In 2605 patients, the risk of experiencing a first vertebral fracture was reduced by 48% (p < 0.001.). The risk of experiencing a second vertebral fracture was reduced by 45% (p < 0.001,; 1100 patients). Moreover, the risk of experiencing more than two vertebral fractures was reduced by 33% (p < 0.001; 1365 patients). Family history of osteoporosis, baseline BMI, and addiction to smoking were not determinants of efficacy. Conclusions: This study shows that a 3-year treatment with strontium ranelate leads to antivertebral fracture efficacy in postmenopausal women independently of baseline osteoporotic risk factors. [less ▲] Detailed reference viewed: 20 (3 ULg) Strontium ranelate reduces the risk of vertebral fracture in patients with osteopenia; ; Reginster, Jean-Yves et alin Osteoporosis International (2006, March), 17(Suppl.1), 50 Detailed reference viewed: 2 (0 ULg) Vertebral fracture risk reduction with strontium ranelate in women with post-menopausal osteoporosis is independent of baseline risk factors; Reginster, Jean-Yves ; et alin Osteoporosis International (2006, March), 17(Suppl.1), 50 Detailed reference viewed: 1 (0 ULg) Strontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women whatever the baseline vertebral fractures status; ; et al in Annals of the Rheumatic Diseases (2005, June), 64(Suppl.III), 359 Detailed reference viewed: 8 (6 ULg) Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) studyReginster, Jean-Yves ; ; et alin Journal of Clinical Endocrinology and Metabolism (2005), 90(5), 2816-2822 Background: Strontium ranelate, a new oral drug shown to reduce vertebral fracture risk in postmenopausal women with osteoporosis, was studied in the Treatment of Peripheral Osteoporosis (TROPOS) study to ... [more ▼] Background: Strontium ranelate, a new oral drug shown to reduce vertebral fracture risk in postmenopausal women with osteoporosis, was studied in the Treatment of Peripheral Osteoporosis (TROPOS) study to assess its efficacy and safety in preventing nonvertebral fractures also. Methods: Strontium ranelate (2 g/d) or placebo were randomly allocated to 5091 postmenopausal women with osteoporosis in a double-blind placebo-controlled 5-yr study with a main statistical analysis over 3 yr of treatment. Findings: In the entire sample, relative risk (RR) was reduced by 16% for all nonvertebral fractures (P = 0.04), and by 19% for major fragility fractures (hip, wrist, pelvis and sacrum, ribs and sternum, clavicle, humerus) (P = 0.031) in strontium ranelate-treated patients in comparison with the placebo group. Among women at high risk of hip fracture ( age ≥ 74 yr and femoral neck bone mineral density T score ≤-3, corresponding to -2.4 according to NHANES reference) (n = 1977), the RR reduction for hip fracture was 36% (P = 0.046). RR of vertebral fractures was reduced by 39% (P < 0.001) in the 3640 patients with spinal x-rays and by 45% in the subgroup without prevalent vertebral fracture. Strontium ranelate increased bone mineral density throughout the study, reaching at 3 yr (P < 0.001): +8.2% (femoral neck) and +9.8% (total hip). Incidence of adverse events (AEs) was similar in both groups. Conclusion: This study shows that strontium ranelate significantly reduces the risk of all nonvertebral and in a high-risk subgroup, hip fractures over a 3-yr period, and is well tolerated. It confirms that strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe and effective means of reducing the risk of fracture associated with osteoporosis. [less ▲] Detailed reference viewed: 22 (3 ULg) Strontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women whatever the baseline vertebral fracture status; ; et al in BONE (2005), 36(S2), 403 Detailed reference viewed: 3 (1 ULg) Strontium ranelate reduces the risk of vertebral fractures in postmenopausal women with osteopenia; Reginster, Jean-Yves ; et alin Osteoporosis International (2004), 15(S1), 119-120 Detailed reference viewed: 8 (4 ULg) Strontium ranelate reduces the risk of vertebral fractures in postmenopausal women with osteopenia; Reginster, Jean-Yves ; et alin Calcified Tissue International (2004), 74(S1), 84 Detailed reference viewed: 3 (2 ULg) Early effect of strontium ranelate on clinical vertebral fractures in women with postmenopausal osteoporosis; ; et al in BONE (2003), 32(S7), 222 Detailed reference viewed: 8 (7 ULg) Strontium ranelate reduces the risk of hip fracture in women with postmenopausal osteoporosisReginster, Jean-Yves ; ; et alin Osteoporosis International (2002, November), 13(Suppl.3), 14 Detailed reference viewed: 12 (0 ULg) Rapid and sustained anti-fracture efficacy of strontium ranelate in postmenopausal osteoporosisReginster, Jean-Yves ; ; et alin Arthritis and Rheumatism (2002, September), 46(number 9 (suppl.)), 584-5 Detailed reference viewed: 9 (0 ULg) |
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