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Skeletal Effects of Raloxifene After 8 Years: Results from the Continuing Outcomes Relevant to Evista (CORE) Study
Author(s) -
Siris Ethel S,
Harris Steven T,
Eastell Richard,
Zanchetta Jose R,
Goemaere Stefan,
DiezPerez Adolfo,
Stock John L,
Song Jingli,
Qu Yongming,
Kulkarni Pandurang M,
Siddhanti Suresh R,
Wong Mayme,
Cummings Steven R
Publication year - 2005
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1359/jbmr.050509
Subject(s) - raloxifene , medicine , placebo , femoral neck , osteoporosis , hazard ratio , breast cancer , confidence interval , cancer , tamoxifen , alternative medicine , pathology
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.