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n h pital Saint-Joseph - Paris

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n h pital Saint-Joseph - Paris

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    2. EVISTA® (Raloxifène HCl, 60 mg/j) Des effets sur la DMO à l’efficacité anti-fracturaire Docteur Gérald Rajzbaum Fondation hôpital Saint-Joseph - Paris Title Slide EVISTA® (Raloxifène 60 mg/day), a Selective Estrogen Receptor Modulator (SERM), for the prevention and treatment of postmenopausal osteoporosis.   Title Slide EVISTA® (Raloxifène 60 mg/day), a Selective Estrogen Receptor Modulator (SERM), for the prevention and treatment of postmenopausal osteoporosis.  

    3. MORE Multiple Outcomes of Raloxifene Evaluation Multicentrique, randomisée, double-aveugle, contre placebo 25 pays, 180 centres, 3 ans plus une extension d ’une année 7705 femmes ostéoporotiques en post ménopause (âge moyen 66.5 ans) Raloxifène 60 mg, 120 mg, ou placebo supplémentation quotidienne de calcium (500 mg) et vitamine D (400-600 UI) Objectifs principaux : fracture vertébrale radiographique, DMO Objectifs secondaires : toute fracture ostéoporotique, tolérance, événements cardiovasculaires, cancer du sein, fonctions supérieures MORE: Multiple Outcomes of Raloxifene Evaluation The Multiple Outcomes of Raloxifene Evaluation (MORE) trial was a large, multicenter, double-blind, placebo controlled trial of postmenopausal women with osteoporosis, enrolling 7705 women at 180 sites in 25 countries.1,2 The trial consisted of a 3-year core treatment phase with a 1-year extension phase. Women were randomly assigned to receive placebo or raloxifene 60 mg/day (Evista), or raloxifene 120 mg/day. All women also received supplemental calcium (500 mg/day) and vitamin D (400 – 600 IU/day).   The primary endpoints of the MORE trial were the incidence of new vertebral fractures and bone mineral density of the lumbar spine and femoral neck. Secondary endpoints included all osteoporotic fractures, serum lipids and other markers of cardiovascular risk, cognitive function, breast cancer, and safety. Major criteria for exclusion from the study included a history of breast or endometrial cancer or the presence of abnormal uterine bleeding.   The dose of raloxifene approved for the prevention and treatment of postmenopausal osteoporosis is 60 mg/day, and effects observed with raloxifene 120 mg/day were comparable to those observed with 60 mg/day. Thus, unless noted otherwise, the data in the subsequent slides will focus on the raloxifene 60 mg/day group compared with placebo.   1. Ettinger B et al. JAMA 1999; 282:637-45 2. Cummings SR et al., JAMA 1999;281:2189-97 MORE: Multiple Outcomes of Raloxifene Evaluation The Multiple Outcomes of Raloxifene Evaluation (MORE) trial was a large, multicenter, double-blind, placebo controlled trial of postmenopausal women with osteoporosis, enrolling 7705 women at 180 sites in 25 countries.1,2 The trial consisted of a 3-year core treatment phase with a 1-year extension phase. Women were randomly assigned to receive placebo or raloxifene 60 mg/day (Evista), or raloxifene 120 mg/day. All women also received supplemental calcium (500 mg/day) and vitamin D (400 – 600 IU/day).   The primary endpoints of the MORE trial were the incidence of new vertebral fractures and bone mineral density of the lumbar spine and femoral neck. Secondary endpoints included all osteoporotic fractures, serum lipids and other markers of cardiovascular risk, cognitive function, breast cancer, and safety. Major criteria for exclusion from the study included a history of breast or endometrial cancer or the presence of abnormal uterine bleeding.   The dose of raloxifene approved for the prevention and treatment of postmenopausal osteoporosis is 60 mg/day, and effects observed with raloxifene 120 mg/day were comparable to those observed with 60 mg/day. Thus, unless noted otherwise, the data in the subsequent slides will focus on the raloxifene 60 mg/day group compared with placebo.   1. Ettinger B et al. JAMA 1999; 282:637-45 2. Cummings SR et al., JAMA 1999;281:2189-97

    4. Evista® augmente la Densité Minérale Osseuse à tous les sites

    5. Effect of Raloxifene on Spine and Femoral Neck BMD This slide shows that the increase in lumbar spine and femoral neck BMD observed with raloxifene 60 mg/day therapy at 3 years, is continued into the 4th year extension phase of MORE. The 2.6% difference in lumbar spine BMD between the placebo and raloxifene groups was maintained. While the femoral neck BMD appeared to decrease after year 3 in the raloxifene group, there was a corresponding decrease in the placebo group during this time. The 2.1% difference in femoral neck BMD between the placebo and raloxifene groups was consistent in years 2, 3 and 4. Raloxifene has effects on both lumbar spine and femoral neck BMD, which are primarily composed of cancellous and cortical bone, respectively. This indicates that raloxifene has systemic skeletal effects.Effect of Raloxifene on Spine and Femoral Neck BMD This slide shows that the increase in lumbar spine and femoral neck BMD observed with raloxifene 60 mg/day therapy at 3 years, is continued into the 4th year extension phase of MORE. The 2.6% difference in lumbar spine BMD between the placebo and raloxifene groups was maintained. While the femoral neck BMD appeared to decrease after year 3 in the raloxifene group, there was a corresponding decrease in the placebo group during this time. The 2.1% difference in femoral neck BMD between the placebo and raloxifene groups was consistent in years 2, 3 and 4. Raloxifene has effects on both lumbar spine and femoral neck BMD, which are primarily composed of cancellous and cortical bone, respectively. This indicates that raloxifene has systemic skeletal effects.

    6. Changement moyen % par rapport à la valeur de base

    7. Le fluor augmente aussi la DMO... et pourtant il augmente le risque de fracture

    8. Relation entre risque de fracture vertébrale et augmentation de la DMO Relationship Between the Risk of Vertebral Fracture and Increases in BMD There is an growing body of evidence suggesting that changes in BMD only partially explain the antifracture efficacy of antiresorptive therapies such as bisphosphonates and SERMs. This phenomenon is illustrated in this slide, showing the percent decrease in risk of vertebral fracture versus the percent increase in spine BMD associated with this effect in double blind prospective clinical trials of calcitonin1, raloxifene2, risedronate3,4, and alendronate5,6. The risk of vertebral fracture was reduced to a comparable extent (35% to 45%) across a relatively broad range of BMD increases (approximately 2% up to almost 7%). These and other data from fracture trials suggest that increases in BMD underestimate the magnitude of fracture reduction achieved with antiresorptive therapies, and suggest that changes in BMD only partially explain their antifracture efficacy. Thus, repeated BMD measurements are not an accurate predictive tool for the antifracture efficacy of most antiresorptive therapies.   1. Chesnut CH, et al. Am J Med. 2000;109:267-276 2. Ettinger B, et al. JAMA. 1999;282:637-645 3. Harris ST, et al. JAMA. 1999;282:1344-1352 4. Reginster J-Y, et al. Osteoporosis Int. 2000;11:83-91 5. Black DM, et al. Lancet. 1996;348:1535-1541 6. Cummings SR, et al. JAMA. 1998;280:2077-2082 Relationship Between the Risk of Vertebral Fracture and Increases in BMD There is an growing body of evidence suggesting that changes in BMD only partially explain the antifracture efficacy of antiresorptive therapies such as bisphosphonates and SERMs. This phenomenon is illustrated in this slide, showing the percent decrease in risk of vertebral fracture versus the percent increase in spine BMD associated with this effect in double blind prospective clinical trials of calcitonin1, raloxifene2, risedronate3,4, and alendronate5,6. The risk of vertebral fracture was reduced to a comparable extent (35% to 45%) across a relatively broad range of BMD increases (approximately 2% up to almost 7%). These and other data from fracture trials suggest that increases in BMD underestimate the magnitude of fracture reduction achieved with antiresorptive therapies, and suggest that changes in BMD only partially explain their antifracture efficacy. Thus, repeated BMD measurements are not an accurate predictive tool for the antifracture efficacy of most antiresorptive therapies.   1. Chesnut CH, et al. Am J Med. 2000;109:267-276 2. Ettinger B, et al. JAMA. 1999;282:637-645 3. Harris ST, et al. JAMA. 1999;282:1344-1352 4. Reginster J-Y, et al. Osteoporosis Int. 2000;11:83-91 5. Black DM, et al. Lancet. 1996;348:1535-1541 6. Cummings SR, et al. JAMA. 1998;280:2077-2082

    9. Efficacité d’Evista® sur le risque de nouvelles fractures vertébrales (symptomatiques) à 1 an

    10. Effect of Raloxifene Treatment on New Vertebral Fractures (MORE Trial-3 Years) This slide summarizes the fracture results from the core 3-year treatment phase of the MORE trial, showing the incidence of new vertebral fractures in women with no preexisting vertebral fractures at baseline (without prevalent vertebral fracture) or with 1 or more preexisting vertebral fractures at baseline (with prevalent vertebral fracture). Women assigned to placebo are represented by the white bars and those assigned to raloxifene 60 mg/d are represented by the yellow bars.   Confirming previous studies, women with 1 or more existing fractures at baseline were at a 5-fold higher risk of experiencing a subsequent vertebral fracture compared with women with no vertebral fractures at baseline. In women without prevalent vertebral fractures, raloxifene 60 mg/day significantly decreased the risk of new vertebral fractures by 55% at 3 years, compared with placebo. In women with prevalent vertebral fractures, who are at greater risk of subsequent fracture, raloxifene 60 mg/day significantly decreased the risk of new vertebral fractures by 30% at 3 years, compared with placebo. The reduction in risk of new vertebral fracture with raloxifene therapy was similar in the following subgroups, as defined according their baseline characteristics: tertiles of age, tertiles of baseline lumbar spine or femoral neck BMD, prior hysterectomy, and prior hormone replacement therapy Ettinger B et al. JAMA 1999; 282:637-45 Lufkin et al. Rheum Dis Clin No Amer 2001;27:163-185   Effect of Raloxifene Treatment on New Vertebral Fractures (MORE Trial-3 Years) This slide summarizes the fracture results from the core 3-year treatment phase of the MORE trial, showing the incidence of new vertebral fractures in women with no preexisting vertebral fractures at baseline (without prevalent vertebral fracture) or with 1 or more preexisting vertebral fractures at baseline (with prevalent vertebral fracture). Women assigned to placebo are represented by the white bars and those assigned to raloxifene 60 mg/d are represented by the yellow bars.   Confirming previous studies, women with 1 or more existing fractures at baseline were at a 5-fold higher risk of experiencing a subsequent vertebral fracture compared with women with no vertebral fractures at baseline. In women without prevalent vertebral fractures, raloxifene 60 mg/day significantly decreased the risk of new vertebral fractures by 55% at 3 years, compared with placebo. In women with prevalent vertebral fractures, who are at greater risk of subsequent fracture, raloxifene 60 mg/day significantly decreased the risk of new vertebral fractures by 30% at 3 years, compared with placebo. The reduction in risk of new vertebral fracture with raloxifene therapy was similar in the following subgroups, as defined according their baseline characteristics: tertiles of age, tertiles of baseline lumbar spine or femoral neck BMD, prior hysterectomy, and prior hormone replacement therapy Ettinger B et al. JAMA 1999; 282:637-45 Lufkin et al. Rheum Dis Clin No Amer 2001;27:163-185  

    11. Concept of Sustained vs. Unsustained Efficacy (also see alternative slide) The concept of sustained efficacy, and how it differs from cumulative efficacy, are important in the context of a therapy targeted to long-term prevention. The graph to the left is a cartoon representation of the efficacy of 2 drugs (A & B) over time. From the beginning of the study (time 0) through time Y, Drug A and Drug B both demonstrate a comparable 50% reduction in risk; thus, the cumulative efficacy appears identical between the two drugs. However, the cumulative 50% risk reduction with Drug A is a composite of a larger risk reduction during the early years of the study followed by declining risk reduction during the later years of the study. The efficacy of Drug A during later years of the study (represented in the graph by time period X ? Y) is substantially less than that observed for the time period 0 ?X. In contrast, the efficacy of Drug B during the period X ? Y is comparable to that observed for the time period 0?X. In other words, the efficacy of Drug B is sustained during the later years of the study whereas that of Drug A is not sustained. This example illustrates why cumulative risk reduction alone (that is, the risk reduction determined from the beginning of a study though a given time point), is not sufficient to demonstrate sustained efficacy. Because a drug that shows a substantial drop in efficacy over time will likely lose clinical benefit sooner than a drug with a stable, sustained efficacy over time, sustained efficacy is a preferred characteristic of long-term therapy. ----OR NEXT SLIDE----   Concept of Sustained vs. Unsustained Efficacy (also see alternative slide) The concept of sustained efficacy, and how it differs from cumulative efficacy, are important in the context of a therapy targeted to long-term prevention. The graph to the left is a cartoon representation of the efficacy of 2 drugs (A & B) over time. From the beginning of the study (time 0) through time Y, Drug A and Drug B both demonstrate a comparable 50% reduction in risk; thus, the cumulative efficacy appears identical between the two drugs. However, the cumulative 50% risk reduction with Drug A is a composite of a larger risk reduction during the early years of the study followed by declining risk reduction during the later years of the study. The efficacy of Drug A during later years of the study (represented in the graph by time period X ? Y) is substantially less than that observed for the time period 0 ?X. In contrast, the efficacy of Drug B during the period X ? Y is comparable to that observed for the time period 0?X. In other words, the efficacy of Drug B is sustained during the later years of the study whereas that of Drug A is not sustained. This example illustrates why cumulative risk reduction alone (that is, the risk reduction determined from the beginning of a study though a given time point), is not sufficient to demonstrate sustained efficacy. Because a drug that shows a substantial drop in efficacy over time will likely lose clinical benefit sooner than a drug with a stable, sustained efficacy over time, sustained efficacy is a preferred characteristic of long-term therapy. ----OR NEXT SLIDE----  

    12. Efficacy of Raloxifene by Study Period Through 4 Years To assess whether raloxifene treatment was associated with sustained decreases in risk of vertebral fracture, the risk of new vertebral fracture among women assigned to raloxifene 60 mg/day relative to placebo was determined cumulatively through 3 years of treatment (purple bars) and during the 4th year alone (green bars). Raloxifene 60 mg/day decreased the cumulative relative risk of new vertebral fractures by 55% and 30% in women without and with prevalent vertebral fractures in years 0-3 [Left panel]. Raloxifene 60 mg/day decreased the relative risk of new vertebral fractures by 50% and 38% in women without and with prevalent vertebral fractures in the 4th year alone [Right panel]. Women without prevalent vertebral fractures had reductions in fracture risk of 50% in year 4 which is similar to the 55% seen in years 0-3. Women with prevalent vertebral fractures had reductions in fracture risk of 30% in year 4 which is similar to the 38% seen in years 0-3. For women with and without existing vertebral fractures at baseline, the reduction in risk of new vertebral fracture associated with raloxifene therapy during the 4th year alone was comparable to the cumulative risk reduction observed during the first 3 years of the trial.1 Therefore, the fracture efficacy of raloxifene 60 mg/day observed during the first 3 years is SUSTAINED in the 4th year. 1. Eastell R et al., J Bone Mineral Res 2000;15:(Suppl 1):p S229Efficacy of Raloxifene by Study Period Through 4 Years To assess whether raloxifene treatment was associated with sustained decreases in risk of vertebral fracture, the risk of new vertebral fracture among women assigned to raloxifene 60 mg/day relative to placebo was determined cumulatively through 3 years of treatment (purple bars) and during the 4th year alone (green bars). Raloxifene 60 mg/day decreased the cumulative relative risk of new vertebral fractures by 55% and 30% in women without and with prevalent vertebral fractures in years 0-3 [Left panel]. Raloxifene 60 mg/day decreased the relative risk of new vertebral fractures by 50% and 38% in women without and with prevalent vertebral fractures in the 4th year alone [Right panel]. Women without prevalent vertebral fractures had reductions in fracture risk of 50% in year 4 which is similar to the 55% seen in years 0-3. Women with prevalent vertebral fractures had reductions in fracture risk of 30% in year 4 which is similar to the 38% seen in years 0-3. For women with and without existing vertebral fractures at baseline, the reduction in risk of new vertebral fracture associated with raloxifene therapy during the 4th year alone was comparable to the cumulative risk reduction observed during the first 3 years of the trial.1 Therefore, the fracture efficacy of raloxifene 60 mg/day observed during the first 3 years is SUSTAINED in the 4th year. 1. Eastell R et al., J Bone Mineral Res 2000;15:(Suppl 1):p S229

    13. Effect of Antiresportive Therapy on the Incidence of Hip Fracture in Postmenopausal Women Across Antiresorptive Studies The incidence of hip fractures varies greatly between clinical trials, as shown in this slide. The ability of a clinical trial to show a statistically significant decreased risk of hip fractures with antiresorptive therapy is associated with the background incidence of hip fractures in the placebo group. The occurrence of hip fractures is greatly increased in women over the age of 70 years.1 Therefore, to determine the effects of antiresorptive therapy on the risk of hip fractures, a clinical trial must enroll large numbers of elderly women who are at highest risk for hip fracture. To date, the clinical trial evidence does not consistently show a decreased risk of hip fracture with antiresorptive agents. The raloxifene2 and risedronate5,6 studies did not show a significant decrease in the risk of hip fractures. Alendronate did not significantly decrease the incidence of hip fractures in women without prevalent vertebral fractures4, although there was a significant decrease in alendronate-treated women with prevalent vertebral fractures.3 None of these clinical trials were designed to examine the effects of antiresorptive therapy on the incidence of hip fractures. The HIP trial with risedronate7 was the only clinical trial designed to assess the effects of antiresorptive therapy on the risk of hip fractures, and enrolled women over 70 years of age, with clinical risk factors for hip fracture. A significant decrease in the risk of hip fracture was observed with risedronate therapy in women aged 70-79 years with established osteoporosis. However, in the same study, women over 80 years of age without osteoporosis, who had clinical risk factors for hip fracture, did not have a significant decrease in hip fracture risk with risedronate. 7 1. Gullberg et al. Osteopor Int 1997; 7: 407-413. Ettinger B, et al. JAMA. 1999;282:637-645. Black DM, et al. Lancet. 1996;348:1535-1541. Cummings SR, et al. JAMA. 1998;280:2077-2082. Harris ST, et al. JAMA. 1999;282:1344-1352. Reginster JY, et al. Osteoporos Int. 2000;11:83-91. McClung MR, et al. N Engl J Med. 2001;344:333-340.Effect of Antiresportive Therapy on the Incidence of Hip Fracture in Postmenopausal Women Across Antiresorptive Studies The incidence of hip fractures varies greatly between clinical trials, as shown in this slide. The ability of a clinical trial to show a statistically significant decreased risk of hip fractures with antiresorptive therapy is associated with the background incidence of hip fractures in the placebo group. The occurrence of hip fractures is greatly increased in women over the age of 70 years.1 Therefore, to determine the effects of antiresorptive therapy on the risk of hip fractures, a clinical trial must enroll large numbers of elderly women who are at highest risk for hip fracture. To date, the clinical trial evidence does not consistently show a decreased risk of hip fracture with antiresorptive agents. The raloxifene2 and risedronate5,6 studies did not show a significant decrease in the risk of hip fractures. Alendronate did not significantly decrease the incidence of hip fractures in women without prevalent vertebral fractures4, although there was a significant decrease in alendronate-treated women with prevalent vertebral fractures.3 None of these clinical trials were designed to examine the effects of antiresorptive therapy on the incidence of hip fractures. The HIP trial with risedronate7 was the only clinical trial designed to assess the effects of antiresorptive therapy on the risk of hip fractures, and enrolled women over 70 years of age, with clinical risk factors for hip fracture. A significant decrease in the risk of hip fracture was observed with risedronate therapy in women aged 70-79 years with established osteoporosis. However, in the same study, women over 80 years of age without osteoporosis, who had clinical risk factors for hip fracture, did not have a significant decrease in hip fracture risk with risedronate. 7 1. Gullberg et al. Osteopor Int 1997; 7: 407-413. Ettinger B, et al. JAMA. 1999;282:637-645. Black DM, et al. Lancet. 1996;348:1535-1541. Cummings SR, et al. JAMA. 1998;280:2077-2082. Harris ST, et al. JAMA. 1999;282:1344-1352. Reginster JY, et al. Osteoporos Int. 2000;11:83-91. McClung MR, et al. N Engl J Med. 2001;344:333-340.

    14. Incidence des événement dans les études MORE et WHI Femmes des groupes placebo The event rates per 1000 patient-years were determined in the placebo groups of the MORE and WHI studies. The WHI study enrolled 8102 postmenopausal women in the placebo group, who had a mean age of 63.3 years. The average follow-up period for WHI was 5.2 years.The WHI study did not examine vertebral fractures with scheduled radiographs. Note that the definition of coronary events was slightly different in the MORE and WHI studies. Differences in the study design and the populations enrolled in each of these trials may contribute to the differences in event rates.  The event rates per 1000 patient-years were determined in the placebo groups of the MORE and WHI studies. The WHI study enrolled 8102 postmenopausal women in the placebo group, who had a mean age of 63.3 years. The average follow-up period for WHI was 5.2 years.The WHI study did not examine vertebral fractures with scheduled radiographs. Note that the definition of coronary events was slightly different in the MORE and WHI studies. Differences in the study design and the populations enrolled in each of these trials may contribute to the differences in event rates.  

    16. Evaluation semiquantitative des fractures vertébrales This slide shows the grading system, developed by Genant’s group, for the semiquantitative (SQ) visual assessment of vertebral fracture severity from spinal radiographs,. Each vertebra received a severity grade of either 0, 1, 2, or 3, depending on the visually apparent degree of vertebral height loss compared with the baseline radiograph. A normal vertebra (grade 0) had less than approximately 20% reduction in vertebral height compared to baseline. Mild vertebral deformities (grade 1) had approximately 20 to 25% reduction in vertebral height. Moderate vertebral fractures (grade 2) had approximately 25-40% decreases in vertebral height. Severe vertebral fractures (grade 3) had decreases in vertebral height of approximately 40% or more. If a patient had more than 1 fracture, the most severe grade of vertebral fracture is considered for the present analyses.This slide shows the grading system, developed by Genant’s group, for the semiquantitative (SQ) visual assessment of vertebral fracture severity from spinal radiographs,. Each vertebra received a severity grade of either 0, 1, 2, or 3, depending on the visually apparent degree of vertebral height loss compared with the baseline radiograph. A normal vertebra (grade 0) had less than approximately 20% reduction in vertebral height compared to baseline. Mild vertebral deformities (grade 1) had approximately 20 to 25% reduction in vertebral height. Moderate vertebral fractures (grade 2) had approximately 25-40% decreases in vertebral height. Severe vertebral fractures (grade 3) had decreases in vertebral height of approximately 40% or more. If a patient had more than 1 fracture, the most severe grade of vertebral fracture is considered for the present analyses.

    17. Caractéristiques initales de la population avec FV sévère –SQ3 – à l’inclusion Etude MORE - 3 ans - This Table shows that women with a higher SQ grade of prevalent vertebral fractures are older, shorter, weigh less, have lower BMD, and have a higher number of prevalent vertebral fractures. All baseline characteristics, except for lumbar spine BMD, were significantly different in women with the most severe SQ3 fractures, compared to women in the other SQ grades.This Table shows that women with a higher SQ grade of prevalent vertebral fractures are older, shorter, weigh less, have lower BMD, and have a higher number of prevalent vertebral fractures. All baseline characteristics, except for lumbar spine BMD, were significantly different in women with the most severe SQ3 fractures, compared to women in the other SQ grades.

    18. Effets d’Evista® sur l’incidence de nouvelles fractures chez les femmes avec une FV initiale de Grade SQ 3 Etude MORE – 3 ans In the small subgroup of women with SQ grade 3 prevalent vertebral fractures, raloxifene 60 mg/d significantly decreased the relative risk of new vertebral fractures by 27% compared with placebo. The corresponding number-needed-to-treat to prevent 1 new vertebral fracture (NNT) was 10. In addition, raloxifene 60 mg/d significantly decreased the relative risk of new nonvertebral fractures by 47% compared with placebo. The corresponding number-needed-to-treat to prevent 1 new nonvertebral fracture was 18. NNT (Number-needed-to-treat) = number of women needed to be treated to prevent a fracture event.In the small subgroup of women with SQ grade 3 prevalent vertebral fractures, raloxifene 60 mg/d significantly decreased the relative risk of new vertebral fractures by 27% compared with placebo. The corresponding number-needed-to-treat to prevent 1 new vertebral fracture (NNT) was 10. In addition, raloxifene 60 mg/d significantly decreased the relative risk of new nonvertebral fractures by 47% compared with placebo. The corresponding number-needed-to-treat to prevent 1 new nonvertebral fracture was 18. NNT (Number-needed-to-treat) = number of women needed to be treated to prevent a fracture event.

    19. EVISTA® chez les femmes avec fracture périphérique à l’inclusion Etude MORE – 3 ans

    20. EVISTA® réduit le risque de fracture vertébrale chez les femmes avec fracture périphérique à l’inclusion Etude MORE – 3 ans

    23. EVISTA® restaure les valeurs préménopausiques des marqueurs du remodelage osseux    

    24. EVISTA® restaure les valeurs préménopausiques des marqueurs du remodelage osseux Postmenopausal women (mean age 63 years) with osteoporosis were treated with raloxifene (n=50) or alendronate (n=65) for 1 year. All women received calcium 500 mg/d and vitamin D 800 IU/d. Biochemical markers of bone formation (procollagen type I N propeptide or PINP) and resorption (C-terminal cross-linking telopeptide of type I collagen or CTX) were measured at baseline and after 1 year of treatment. The levels were compared to premenopausal values obtained in 65 healthy women. After 1 year treatment with raloxifene, serum levels of CTX and PINP decreased to mean premenopausal levels while treatment with alendronate resulted in a significant suppression of both markers to below the lower limit of premenopausal range. Postmenopausal women (mean age 63 years) with osteoporosis were treated with raloxifene (n=50) or alendronate (n=65) for 1 year. All women received calcium 500 mg/d and vitamin D 800 IU/d. Biochemical markers of bone formation (procollagen type I N propeptide or PINP) and resorption (C-terminal cross-linking telopeptide of type I collagen or CTX) were measured at baseline and after 1 year of treatment. The levels were compared to premenopausal values obtained in 65 healthy women. After 1 year treatment with raloxifene, serum levels of CTX and PINP decreased to mean premenopausal levels while treatment with alendronate resulted in a significant suppression of both markers to below the lower limit of premenopausal range.

    25. Conclusions Evista® augmente la DMO tant au niveau du rachis qu’au niveau fémoral Evista® réduit le risque de fractures vertébrales rapidement, année après année, y compris chez les femmes préalablement traitées par THS, ou chez les femmes avec un antécédent de fracture périphérique (poignet, …) Evista® ramène le niveau des marqueurs du remodelage aux valeurs pré-ménopausiques

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