In:
Journal of Bone and Mineral Research, Wiley, Vol. 20, No. 9 ( 2005-09), p. 1514-1524
Abstract:
In the CORE breast cancer trial of 4011 women continuing from MORE, the incidence of nonvertebral fractures at 8 years was similar between placebo and raloxifene 60 mg/day. CORE had limitations for assessing fracture risk. In a subset of 386 women, 7 years of raloxifene treatment significantly increased lumbar spine and femoral neck BMD compared from the baseline of MORE. Introduction : The multicenter, double‐blind Continuing Outcomes Relevant to Evista (CORE) trial assessed the effects of raloxifene on breast cancer for 4 additional years beyond the 4‐year Multiple Outcomes of Raloxifene Evaluation (MORE) osteoporosis treatment trial. Materials and Methods : In CORE, placebo‐treated women from MORE continued with placebo ( n = 1286), whereas those previously given raloxifene (60 or 120 mg/day) received raloxifene 60 mg/day ( n = 2725). As a secondary endpoint, new nonvertebral fractures were analyzed as time‐to‐first event in 4011 postmenopausal women at 8 years. A substudy assessed lumbar spine and femoral neck BMD at 7 years, with the primary analysis based on 386 women (127 placebo, 259 raloxifene) who did not take other bone‐active agents from the fourth year of MORE and who were ≥80% compliant with study medication in CORE. Results : The risk of at least one new nonvertebral fracture was similar in the placebo (22.9%) and raloxifene (22.8%) groups (hazard ratio {HR}, 1.00; Bonferroni‐adjusted CI, 0.82, 1.21). The incidence of at least one new nonvertebral fracture at six major sites (clavicle, humerus, wrist, pelvis, hip, lower leg) was 17.5% in both groups. Posthoc Poisson analyses, which account for multiple events, showed no overall effect on nonvertebral fracture risk, and a decreased risk at six major nonvertebral sites in women with prevalent vertebral fractures (HR, 0.78; 95% CI, 0.63, 0.96). At 7 years after MORE randomization, the differences in mean lumbar spine and femoral neck BMD with raloxifene were 1.7% ( p = 0.30) and 2.4% ( p = 0.045), respectively, from placebo. Compared with MORE baseline, after 7 years, raloxifene treatment significantly increased lumbar spine (4.3% from baseline, 2.2% from placebo) and femoral neck BMD (1.9% from baseline, 3.0% from placebo). BMDs were significantly increased from MORE baseline at all time‐points at both sites with raloxifene. Conclusion : Raloxifene therapy had no effect on nonvertebral fracture risk after 8 years, although CORE had limitations for fracture risk assessment. BMD increases were maintained after 7 years of raloxifene.
Type of Medium:
Online Resource
ISSN:
0884-0431
,
1523-4681
Language:
English
Publisher:
Wiley
Publication Date:
2005
detail.hit.zdb_id:
2008867-X
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