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001-es BibID:	BIBFORM005618
Első szerző:	Reginster, Jean-Yves
Cím:	Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis / Jean-Yves Reginster, Dieter Felsenberg, Steven Boonen, Adolfo Diez-Perez, Rene Rizzoli, Maria-Luisa Brandi, Tim D. Spector, Kim Brixen, Stefan Goemaere, Catherine Cormier, Adam Balogh, Pierre D. Delmas, Pierre J. Meunier
Dátum:	2008
Megjegyzések:	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.
Tárgyszavak:	Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Arthritis and Rheumatism 58 : 6 (2008), p. 1687-1695. -
További szerzők:	Felsenberg, Dieter Boonen, Steven Diez-Perez, Adolfo Rizzoli, Rene Brandi, Maria-Luisa Spector, Tim D. Brixen, Kim Goemaere, Stefan Cormier, Catherine Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Delmas, Pierre D. Meunier, Pierre J.
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001-es BibID:	BIBFORM042521
035-os BibID:	PMID:22124575
Első szerző:	Reginster, J-Y.
Cím:	Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis / Reginster, J-Y., 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, O., Roux, C.
Dátum:	2012
ISSN:	0937-941X
Megjegyzések:	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.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Osteoporosis International 23 : 3 (2012), p. 1115-1122. -
További szerzők:	Kaufman, J-M. Goemaere, Stefan Devogelaer, Jean-Pierre Benhamou, C. L. Felsenberg, Dieter Diaz-Curiel, M. Brandi, M-L. Badurski, Janusz E. Wark, J. Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Bruyère, Olivier Roux, Christian
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