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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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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 elektronikus változat
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