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Protelos Long-Term Antifracture Efficacy
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Protelos Vertebral Antifracture Efficacy over 4 years in SOTI Favors Protelos RR P<0.001 - 33% All vertebral fractures P<0.001 - 36% Clinical vertebral fractures 00.511.5
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Protelos Antifracture Efficacy over 5 years in TROPOS Favors Protelos RR 00.511.5 P=0.03 - 15% All non vertebral fractures P=0.03 - 18% Major non vertebral fractures P<0.001 - 24% All vertebral fractures
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Meunier P.J et al. NEJM.2004 Reginster J.Y et al. JCEM 2005 Relative change from baseline Protelos Increase in Lumbar Spine BMD placeboProtelos 2 g/day Mean change (%) - 4 0 4 8 12 16 061218243036 + 14.4 % SOTI * * * * * * - 4 0 4 8 1216 061218243036 Mean change (%) * * * * * * + 14.7 % TROPOS *P<0.001
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Relative change from baseline Protelos Increase in Femoral Neck BMD placeboProtelos 2 g/day - 4 - 2 0 2 4 6 8 061218243036 Mean change (%) + 8.2 % TROPOS * * * * * * - 4 - 2 0 2 4 6 8 061218243036 Mean change (%) * * * * * * + 8.3% SOTI *P<0.001 Meunier P.J et al. NEJM.2004 Reginster J.Y et al. JCEM 2005
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Protelos: BMD Changes Predict Antifracture Efficacy RR of experiencing a new clinical vertebral fracture after 3 years per 1% increase in hip BMD (after 3 years). 0.9 0.91 0.92 0.93 0.94 0.95 0.96 0.97 0.98 0.99 Total hipFemoral neck RR 95% CI Bruyere et coll: ECCEO6.
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Protelos: BMD Changes Predict Antifracture Efficacy RR of experiencing a new clinical vertebral fracture after 3 years in patients with or without (0%) increase in total hip or femoral neck BMD (after 3 years) 0 0.2 0.4 0.6 0.8 1 Total hip BMD changes >0%Femoral neck BMD changes>0% RR 95% CI Bruyere et coll. ECCEO6.
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Protelos Normalizes BMD in Osteopenic Patients 1428 subjects from SOTI and TROPOS with osteopenia at the non osteoporotic site. SR 2g/day or placebo for 4-5 years % of subjects with BMD normalized (T Score>-1) at the end of treatment RR (95% CI) Malaise O. et al. Aging. 2007. in print. RR=12.38 (5.04-30.45) RR=4.87 (3.13-7.57)
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Pts % 0 5 10 15 20 25 30 35 Protelos 41% 45% 37% 59% LS 72% LS/FN 56% LS/FN LS Osteoporosis + Fx Osteopenia + Fx Osteoporosis - Fx Osteopenia - Fx SOTI TROPOS Placebo Protelos Broad Range of Efficacy
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Non-Vertebral Fx in Elderly Patients 0 5 10 15 20 25 30 Patients (%) Placebo 29.0% P = 0.019 RR= 0.73 [0.57-0.95] N = 1489 24.9% RR 27% Vertebral Fracture Risk in Elderly Patients 0 5 10 15 20 25 30 Patients (%) Placebo Protelos 35.3% 5 years P = 0.010 RR= 0.69 [0.52-0.92] N = 896 26.6% RR 31% 35 Protelos
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Treatment Effects of Protelos on Vertebral Fracture Risk Favors Protelos osteopenic without prevalent F - 72% P=0.045 Over 3 years - 38% P<0.001 Clinical VF - 45% without prevalent VF P<0.001 - 41% with prevalent VF P<0.001 Vertebral F - 32% P=0.013 80 years Clinical VF P=0.003 - 52% RR After 1 year RELATIVE RISKS AND 95% CI P<0.001 - 49% Vertebral F 00.511.5
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Treatment Effects of Protelos on Nonvertebral Fracture Risk Major nonvertebral fractures: humerus, pelvis-sacrum, ribs-sternum, hip, clavicle, wrist. Favors Protelos Over 3 years Nonvert. fractures - 16% P=0.04 Hip fractures, 74 years - 36% P=0.046 Major nonvert. fractures - 19% P=0.031 RR - 31% Nonvert. fractures, 80 years P=0.011 00.511.5
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Long-Term Vertebral and Nonvertebral Fracture Risk Reductions with Protelos Favors Protelos Vertebral fractures P<0.001 - 33% RR Over 4 years RELATIVE RISKS AND 95% CI P<0.001 - 36% Clinical vertebral fractures Over 5 years 00.511.5 - 24% P<0.001 Vertebral fractures - 15% P=0.025 - 18% Non vertebral fractures P=0.032 Major non vertebral fractures P=0.010 - 31% Vertebral fractures, 80 years P=0.018 - 27% Non-vertebral fractures, 80 years
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Conclusion Osteoporosis is a global burden Still many medical unmet needs Bone is a living tissue Protelos has a unique dual mode of action Protelos has the broadest range of antifracture efficacy
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