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Raloxifene: results from the MORE study.

D Agnusdei1, N Iori

  • 1Skeletal Diseases, Eli Lilly and Co., Italy. agnusdei_donato@lilly.com

Journal of Musculoskeletal & Neuronal Interactions
|March 11, 2005
PubMed
Summary

Raloxifene, a SERM, maintains bone density and significantly reduces vertebral fractures in postmenopausal women. It also lowers breast cancer risk, offering a new option for postmenopausal health.

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Area of Science:

  • Endocrinology
  • Pharmacology
  • Gerontology

Background:

  • Osteoporosis is a major health concern for postmenopausal women, increasing fracture risk.
  • Selective Estrogen Receptor Modulators (SERMs) offer a therapeutic option by mimicking estrogen's beneficial effects on bone.

Purpose of the Study:

  • To evaluate raloxifene's efficacy in preventing and treating osteoporosis in postmenopausal women.
  • To assess raloxifene's impact on bone mineral density (BMD), vertebral fractures, and breast cancer risk.

Main Methods:

  • Two studies: an osteoporosis prevention study (601 women) and the MORE trial (7705 postmenopausal women with osteoporosis).
  • Participants received raloxifene (30-150 mg/day) or placebo, with calcium and vitamin D supplementation.
  • Primary endpoints included changes in BMD and the incidence of new vertebral and non-vertebral fractures.

Main Results:

  • Raloxifene (60 mg/day) increased BMD by 2.4% at the lumbar spine and hip in healthy postmenopausal women.
  • In women with osteoporosis, raloxifene significantly reduced new vertebral fractures by 31-55%.
  • Raloxifene use was associated with an increased risk of deep vein thrombosis and pulmonary embolism, but a 65% reduced risk of breast cancer.

Conclusions:

  • Raloxifene effectively maintains BMD and reduces vertebral fracture risk in postmenopausal women.
  • Raloxifene also demonstrates a significant protective effect against breast cancer in this population.
  • The benefits of raloxifene must be weighed against potential risks like thromboembolic events.

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