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001-es BibID:BIBFORM042783
035-os BibID:PMID:12161484
Első szerző:Delmas, Pierre D.
Cím:Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis : four-year results from a randomized clinical trial / Pierre D. Delmas, Kristine E. Ensrud, Jonathan D. Adachi, Kristine D. Harper, Somnath Sarkar, Carlo Gennari, Jean-Yves Reginster, Huibert A. P. Pols, Robert R. Recker, Steven T. Harris, Wentao Wu, Harry K. Genant, Dennis M. Black, Richard Eastell, Mulitple Outcomes of Raloxifene Evaluation (MORE) Investigators
Dátum:2002
ISSN:0167-6806
Megjegyzések:The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999): 637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
külföldön készült közlemény
Megjelenés:The Journal of Clinical Endocrinology and Metabolism. - 87 : 8 (2002), p. 3609-3617. -
További szerzők:Ensrud, Kristine E. Adachi, Jonathan D. Harper, Kristine D. Sarkar, Somnath Gennari, Carlo Reginster, Jean-Yves Pols, Huibert A. P. Recker, Robert R. Harris, Steven T. Wu, Wentao Genant, Harry K. Black, Dennis M. Eastell, Richard Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) The Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
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2.

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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3.

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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4.

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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5.

001-es BibID:BIBFORM042526
035-os BibID:PMID: 17997711
Első szerző:Seeman, Ego
Cím:Strontium ranelate reduces the risk of vertebral fractures in patients with osteopenia / Seeman Ego, Devogelaer Jean-Pierre, Lorenc Roman, Spector Timothy, Brixen Kim, Balogh Adam, Stucki Gerold, Reginster Jean-Yves
Dátum:2008
ISSN:0884-0431
Megjegyzések:Many fractures occur in women with moderate fracture risk caused by osteopenia. Strontium ranelate was studied in 1431 postmenopausal women with osteopenia. Vertebral fracture risk reduction of 41-59% was shown depending on the site and fracture status at baseline. This is the first report of antivertebral fracture efficacy in women with vertebral osteopenia.INTRODUCTION:Women with osteoporosis are at high risk for fracture. However, more than one half of all fractures in the community originate from the larger population at more moderate risk of fracture caused by osteopenia. Despite this, evidence for antifracture efficacy in these persons is limited. The aim of this study was to determine whether strontium ranelate, a new drug that reduces fracture risk in women with osteoporosis, is also effective in women with osteopenia.MATERIALS AND METHODS:Data from the Spinal Osteoporosis Therapeutic Intervention study (SOTI; n = 1649) and the TReatment Of Peripheral OSteoporosis (TROPOS; n = 5091) were pooled to evaluate the antivertebral fracture efficacy of strontium ranelate in women with lumbar spine (LS) osteopenia with any BMD value at the femoral neck (FN; N = 1166) and in 265 women with osteopenia at both sites (intention-to-treat analysis). The women were randomized to strontium ranelate 2 g/d orally or placebo for 3 yr.RESULTS:No group differences were present in baseline characteristics that may influence fracture outcome independent of therapy. In women with LS osteopenia, treatment reduced the risk of vertebral fracture by 41% (RR = 0.59; 95% CI, 0.43-0.82), by 59% (RR = 0.41; 95% CI, 0.17-0.99) in the 447 patients with no prevalent fractures, and by 38% (RR = 0.62; 95% CI, 0.44-0.88) in the 719 patients with prevalent fractures. In women with osteopenia at both sites, treatment reduced the risk of fracture by 52% (RR = 0.48; 95% CI, 0.24-0.96).CONCLUSIONS:Strontium ranelate safely reduces the risk of vertebral fractures in women with osteopenia with or without a prevalent fracture.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
osteopenia
vertebral fracture risk reduction
strontium ranelate
Megjelenés:Journal of Bone And Mineral Research. - 23 : 3 (2008), p. 433-438. -
További szerzők:Devogelaer, Jean-Pierre Lorenc, Roman Spector, Timothy Brixen, Kim Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Stucki, Gerold Reginster, Jean-Yves
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DOI
Intézményi repozitóriumban (DEA) tárolt változat
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