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001-es BibID:BIBFORM042522
Első szerző:Meunier, Pierre J.
Cím:The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in Women with Postmenopausal Osteoporosis / Meunier, Pierre J., Roux, Christian, Seeman, Ego, Ortolani, Sergio, Badurski, Janusz E., Spector, Tim D., Cannata, Jorge, Balogh, Adam, Lemmel, Ernst-Martin, Pors-Nielsen, Stig, Rizzoli, René, Genant, Harry K., Reginster, Jean-Yves
Dátum:2004
ISSN:0028-4793
Megjegyzések:Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.METHODS:To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months.RESULTS:New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events.CONCLUSIONS:Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine. - 350 : 5 (2004), p. 459-468. -
További szerzők:Roux, Christian Seeman, Ego Ortolani, S. Badurski, Janusz E. Spector, Tim D. Cannata, Jorge B. Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Lemmel, Ernst-Martin Pors-Nielsen, Stig Rizzoli, Rene Genant, Harry K. Reginster, Jean-Yves Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos)
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001-es BibID:bibEBI00019025
Első szerző:Reginster, Jean-Yves
Cím:Strontium ranelate reduces the risk of vertebral fractures in osteoporotic postmenopausal women without prevalent vertebral fracture / Reginster J.-Y., Rizzoli R., Balogh Á., Badurski J., Spector T., Tulassay Z., Felsenberg D., Cannata J. B., Phenekos C., Ortolani S., Meunier P. J.
Dátum:2005
Tárgyszavak:Orvostudományok Elméleti orvostudományok idézhető absztrakt
Megjelenés:Osteoporosis International. - 16 : Suppl.3 (2005), p. S53. -
További szerzők:Rizzoli, Rene Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Badurski, Janusz E. Spector, Thomas Tulassay Zsolt (1944-) (belgyógyász, gasztroenterológus) Felsenberg, Dieter Cannata, Jorge B. Phenekos, Costas Ortolani, S. Meunier, Pierre J.
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3.

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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