Raloxifene ( Evista ) 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.

Researchers, at National Cancer Institute ( NCI ), evaluated the effect of Raloxifene in premenopausal women at increased risk for breast cancer on bone mineral density ( BMD ).

Phase II clinical trial was conducted at an academic medical center; participants: 37 premenopausal women at increased risk for breast cancer enrolled on the trial. 30 subjects began treatment and 27 were evaluable.

Raloxifene ( 60 mg daily ) and Calcium ( 1200 mg daily ) were given for 2 years.
Subjects were followed off medications for 1 year.

The primary endpoint was the intrasubject percent change in BMD at one year measured by dual energy x-ray absorptiometry ( DEXA ).

The mean baseline lumbar spine density was 1.027 g/cm( 2 ). Lumbar spine density decreased 2.3% at one year ( p-value <0.00001 ) and 3.5% ( p-value <0.00001 ) at two years.
Percent change from year 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 year and 1.0% at 2 year ( p-value 0.033 ).
Percent change from year 2 to year 3 was +1.7%.

Raloxifene use is associated with a decrease in bone mineral density in premenopausal women at increased risk for breast cancer. The clinical significance of this decrease is unknown and is attenuated with stopping Raloxifene.

Source: Journal of Clinical Endocrinology and Metabolism, 2006


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