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MORE-CORE trial

Study characteristics: - Manufacturer sponsored trial - Randomized, placebo controlled - CORE is an extension of the MORE trial [3] - raloxifene 60 or 120 mg QD - all received 500 mg of calcium + 400 IU vitamin D QD - 7705 postmenopausal women with established osteoporosis - T score < -2.5 or at least 1 vertebral fracture - bone mineral density T scores < -2 Results: 1) either dose of raloxifene reduced risk of vertebral fracture (RR 0.53-0.54) 2) neither dose prevented all non-spinal fractures 3) reduced risk of breast cancer (RR 0.25) group (2 vs 5 cases per 100,000 women-years) [3] 4) increased risk of pulmonary embolism in raloxifene group 0.62% vs 0.16% over 8 years

Related

bone mineral density (BMD) osteoporosis raloxifene (Evista) vitamin D

General

clinical trial

References

  1. Greenwood G. In: Intensive Course in Geriatric Medicine & Board Review, Marina Del Ray, CA, Sept 12-15, 2001
  2. Cummings SR et al. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. Multiple Outcomes of Raloxifene Evaluation. JAMA 281:2189, 1999 PMID: 10376571
  3. Journal Watch 25(2):15, 2005 Martino S, Cauley JA, Barrett-Connor E, Powles TJ, Mershon J, Disch D, Secrest RJ, Cummings SR; CORE Investigators. Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst. 2004 Dec 1;96(23):1751-61. PMID: 15572757
  4. Prescriber's Letter 12(2): 2005 Role of Raloxifene in Breast Cancer Prevention: CORE Results Detail-Document#: 210214 (subscription needed) http://www.prescribersletter.com