Effect of raloxifene on bone mineral density in premenopausal women at increased risk of breast cancer

J Clin Endocrinol Metab. 2006 Oct;91(10):3941-6. doi: 10.1210/jc.2005-2827. Epub 2006 Jul 25.

Abstract

Context: Raloxifene is a promising breast cancer prevention agent in postmenopausal women at increased risk for breast cancer. The effects of raloxifene in premenopausal women are unknown.

Objective: We evaluated the effect of raloxifene in premenopausal women at increased risk for breast cancer on bone mineral density (BMD).

Design: This was a phase II clinical trial.

Setting: This study was conducted at an academic medical center.

Participants: Thirty-seven premenopausal women at increased risk for breast cancer enrolled in the trial. Thirty subjects began treatment and 27 were evaluable.

Intervention: Raloxifene (60 mg daily) and elemental calcium (500 mg daily) were given for 2 yr. Subjects were followed up off medications for 1 yr.

Main outcome measure: The primary end point was the intrasubject percent change in BMD at 1 yr measured by dual-energy x-ray absorptiometry.

Results: The mean baseline lumbar spine density was 1.027 g/cm(2). Lumbar spine density decreased 2.3% at 1 yr (P < 0.00001) and 3.5% at 2 yr (P < .00001). Percent change from yr 2 to 3 was +1.4%. The mean baseline total hip bone density was 0.905 g/cm(2). Total hip density decreased 0.3% at 1 yr and 1.0% at 2 yr (P = 0.033). Percent change from yr 2 to 3 was +1.7%.

Conclusions: Raloxifene use is associated with a decrease in BMD in premenopausal women at increased risk for breast cancer. The clinical significance of this decrease is unknown and is attenuated with stopping raloxifene.

Publication types

  • Clinical Trial, Phase II
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adult
  • Bone Density / drug effects*
  • Breast Neoplasms / prevention & control*
  • Female
  • Fibrinogen / analysis
  • Humans
  • Lipids / blood
  • Middle Aged
  • Premenopause
  • Quality of Life
  • Raloxifene Hydrochloride / adverse effects
  • Raloxifene Hydrochloride / pharmacology*
  • Selective Estrogen Receptor Modulators / pharmacology*

Substances

  • Lipids
  • Selective Estrogen Receptor Modulators
  • Raloxifene Hydrochloride
  • Fibrinogen