1. Novel Treatments for Osteoporosis Prof. Steven R. Cummings, MD San Francisco Coordinating Center Support from Novartis, Lilly, Organon, Pfizer, Amgen, NIH, Zelos
37. 4 years of Raloxifene decreased the risk of vertebral fracture* % with fracture Placebo RLX 60 RLX120 * Among women with vertebral fracture 36% 43%
38. 4 years of raloxifene did not decrease the risk of non-spine fractures % with fractures 0 6 12 18 24 30 36 15 10 5 0 Months Placebo Raloxifene RR = 0.93 (0.81, 1.06)
39. RUTH Trial: Raloxifene does not decrease the risk of CHD Barrett-Connor, N Engl J Med 2006;355:125
40. 5 years of tamoxifen reduced the risk of ER+, not ER- breast cancer Fisher et al. , J Natl Cancer Inst 1998;90:1371-88 # events 76%
41. • 5 years of tamoxifen continues to reduce breast cancer risk and mortality for at least 10 years after stopping treatment • Adverse effects (and costs) last only 5 years Early Breast Cancer Clinical Trialists Group. Lancet 2005;365:1687 Benefits Persist Off Treat
42. RUTH Trial: Raloxifene does not decrease the risk of CHD Barrett-Connor, N Engl J Med 2006;355:125
43. Lasofoxifene improved spine BMD more than raloxifene 3% 1.7% *p<0.05 vs placebo; †p<0.05 vs raloxifene. % Change From Baseline * * † Raloxifene 60 mg/d Lasofoxifene 0.25 mg/d Placebo
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47. Percent Change vs. Placebo p ≤ 0.001 for all -12.5 (-25.1, 0.1) -15.8 (-26.7, -4.9) C-reactive Protein -15.8 (-19.5,-12.0) -16.2 (-19.7,-12.7) LDL-cholesterol +3.0 (2.7, 3.4) +2.9 (2.6, 3.2) Fem neck BMD +3.1 (2.8, 3.5) +3.0 (2.6, 3.3) Spine BMD 0.5 0.25 Lasofoxifene, mg/d