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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: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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