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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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DOI
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2.

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.
Internet cím:DOI
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3.

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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