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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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001-es BibID:BIBFORM042776
Első szerző:Ettinger, Bruce
Cím:Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene : results from a 3-year randomized clinical trial / Bruce Ettinger, Dennis M. Black, Bruce H. Mitlak, Ronald K. Knickerbocker, Thomas Nickelsen, Harry K. Genant, Claus Christiansen, Pierre D. Delmas, Jose R. Zanchetta, Jacob Stakkestad, Claus C. Glüer, Kathryn Krueger, Fredric J. Cohen, Stephen Eckert, Kristine E. Ensrud, Louis V. Avioli, Paul Lips, Steven R. Cummings, for the Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators
Dátum:1999
Megjegyzések:Raloxifene hydrochloride, a selective estrogen receptor modulator, prevents bone loss in postmenopausal women, but whether it reduces fracture risk in these women is not known.OBJECTIVE:To determine the effect of raloxifene therapy on risk of vertebral and nonvertebral fractures.DESIGN:The Multiple Outcomes of Raloxifene Evaluation (MORE) study, a multicenter, randomized, blinded, placebo-controlled trial.SETTING AND PARTICIPANTS:A total of 7705 women aged 31 to 80 years in 25 countries who had been postmenopausal for at least 2 years and who met World Health Organization criteria for having osteoporosis. The study began in 1994 and had up to 36 months of follow-up for primary efficacy measurements and nonserious adverse events and up to 40 months of follow-up for serious adverse events.INTERVENTIONS:Participants were randomized to 60 mg/d or 120 mg/d of raloxifene or to identically appearing placebo pills; in addition, all women received supplemental calcium and cholecalciferol.MAIN OUTCOME MEASURES:Incident vertebral fracture was determined radiographically at baseline and at scheduled 24- and 36-month visits. Nonvertebral fracture was ascertained by interview at 6-month-interim visits. Bone mineral density was determined annually by dual-energy x-ray absorptiometry.RESULTS:At 36 months of the evaluable radiographs in 6828 women, 503 (7.4%) had at least 1 new vertebral fracture, including 10.1% of women receiving placebo, 6.6% of those receiving 60 mg/d of raloxifene, and 5.4% of those receiving 120 mg/d of raloxifene. Risk of vertebral fracture was reduced in both study groups receiving raloxifene (for 60-mg/d group: relative risk [RR], 0.7; 95% confidence interval [CI], 0.5-0.8; for 120-mg/d group: RR, 0.5; 95% CI, 0.4-0.7). Frequency of vertebral fracture was reduced both in women who did and did not have prevalent fracture. Risk of nonvertebral fracture for raloxifene vs placebo did not differ significantly (RR, 0.9; 95% CI, 0.8-1.1 for both raloxifene groups combined). Compared with placebo, raloxifene increased bone mineral density in the femoral neck by 2.1 % (60 mg) and 2.4% (120 mg) and in the spine by 2.6% (60 mg) and 2.7% (120 mg) P<0.001 for all comparisons). Women receiving raloxifene had increased risk of venous thromboembolus vs placebo (RR, 3.1; 95% CI, 1.5-6.2). Raloxifene did not cause vaginal bleeding or breast pain and was associated with a lower incidence of breast cancer.CONCLUSIONS:In postmenopausal women with osteoporosis, raloxifene increases bone mineral density in the spine and femoral neck and reduces risk of vertebral fracture.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
külföldön készült közlemény
Megjelenés:JAMA : the Journal of the American Medical Association. - 282 : 7 (1999), p. 637-645. -
További szerzők:Black, Dennis M. Mitlak, Bruce H. Knickerbocker, Ronald K. Nickelsen, Thomas Genant, Harry K. Christiansen, Claus Delmas, Pierre D. Zanchetta, Jose R. Stakkestad, Jacob Glüer, Claus C. Krueger, Kathryn Cohen, Fredric J. Eckert, Stephen Ensrud, Kristine E. Avioli, Louis V. Lips, Paul Cummings, Steven R. 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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3.

001-es BibID:BIBFORM042518
035-os BibID:PMID: 15068500
Első szerző:Johnell, Olof
Cím:Associations Between Baseline Risk Factors and Vertebral Fracture Risk in the Multiple Outcomes of Raloxifene Evaluation (MORE) Study / Johnell Olof, Kanis John A., Black Dennis M., Balogh Adam, Poor Gyula, Sarkar Somnath, Zhou Chunmei, Pavo Imre
Dátum:2004
ISSN:0884-0431
Megjegyzések:Different risk factors may influence the effectiveness of osteoporosis therapies. The interaction of 30 baseline risk factors and the effectiveness of raloxifene in the MORE study were assessed. The efficacy of raloxifene in reducing vertebral fractures is largely independent of the presence of clinical risk factors for osteoporotic fractures.INTRODUCTION:The aim of this analysis was to determine the effect of different risk factors on the effectiveness of raloxifene to reduce vertebral fractures in the Multiple Outcomes of Raloxifene Evaluation (MORE) study using logistic regression models.MATERIALS AND METHODS:The association was assessed using univariate analyses and a multivariate model between 30 potential risk factors at baseline and the risk of vertebral fractures after 3 years in the placebo group, as well as the interaction of risk factors with raloxifene therapy (at a dose of 60 or 120 mg/day).RESULTS AND CONCLUSIONS:In the univariate analysis of the placebo group, after adjusting for baseline lumbar spine BMD (LS BMD), short stature (odds ratio [OR] = 1.18), age (OR = 1.38), years since menopause (OR = 1.38), impaired cognitive function, visuospatial capabilities (OR = 1.19), impaired musculoskeletal strength (OR = 1.23), low femoral neck BMD (OR = 1.21), and prior vertebral fracture (OR = 4.95) were significantly associated with the incidence of new vertebral fractures. In the univariate analysis, significant interactions were observed between raloxifene treatment and age (p = 0.04), serum triglycerides (p = 0.03), LS BMD (p = 0.08), and diabetes mellitus (p = 0.04). In the multivariate analysis, the effectiveness of raloxifene was independent of almost all risk factors, with the exception of baseline serum triglyceride level and LS BMD, suggesting an increased efficacy of raloxifene in patients with increased triglyceride levels (p = 0.006) and lower LS BMD values (p = 0.008) at baseline. These data suggest that the efficacy of raloxifene in reducing vertebral fractures is largely independent of the presence of clinical risk factors for osteoporotic fractures.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Journal Of Bone And Mineral Research. - 19 : 5 (2004), p. 764-772. -
További szerzők:Kanis, John A. Black, Dennis M. Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Poór Gyula Sarkar, Somnath Zhou, Chunmei Pávó Imre J.
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