Figure 6 The effect of raloxifene on (a) bone mineral density and vertebral fracture in postmenopausal women with osteoporoisis79 and (b) breast cancer incidence168 in the MORE trial. At 36 months of the evaluable radiographs in 6828 women, risk of vertebral fracture was reduced in both study groups receiving raloxifene (60mgday -1 group: RR, 0.62; 95% CI, 0.5-0.8; 120 mg day-1 group: RR, 0.5; 95% CI, 0.4-0.7). The cumulative incidence of breast cancer among subjects in the placebo group and those in the combined raloxifene group are represented as a percentage of all patients randomized to either group. Statistical significance of the difference between the groups was tested by a log-rank test (P < 0.001).
60 mg day"1 reduced the risk of vertebral fractures by 30% (RR, 0.7; 95% CI 0.5-0.8) and by 50% (RR, 0.5; 95% CI 0.4-0.7) at 120mgday-1, compared to placebo (Figure 6a). The risk of nonvertebral fracture for raloxifene versus placebo, however, did not differ significantly.79 Compared with placebo, raloxifene also 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.79
As a follow-up to the MORE trial, the CORE trial (Figure 7) was developed. The CORE study was designed to evaluate the long-term efficacy of 4 additional years of raloxifene therapy in reducing the incidence of invasive breast cancer in postmenopausal women with osteoporosis who previously were treated with raloxifene in the MORE trial. Siris and coworkers83 reported that, after 7 years of the MORE trial, compared with MORE baseline, raloxifene treatment significantly increased lumbar spine (4.3% from baseline, 2.2% from placebo) and femoral neck bone mineral density (1.9% from baseline, 3.0% from placebo). Bone mineral densities were also significantly increased from MORE baseline at all time-points at both sites with raloxifene.
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