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Medical Oncology Clinical Research Unit (J.E.-W., J.Z.) and Surgical Oncology Branch (D.D.), National Cancer Institute, and Clinical Center (J.C.R., D.V., D.L., S.G., C.C.), National Institutes of Health, Bethesda, Maryland 20892; and Genome Institute of Singapore (E.T.L.), Genome, Singapore 138672
Address all correspondence and requests for reprints to: Jennifer Eng-Wong, Medical Oncology Clinical Research Unit, National Cancer Institute, Building 10, Room 12N226, 9000 Wisconsin Avenue, Bethesda, Maryland 20892. E-mail: engwongj{at}mail.nih.gov.
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/cm2. 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/cm2. 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.
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