The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
237
1mg/Day Oral
35mg/week, oral
Research Site
Palm Springs, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
New Orleans, Louisiana, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Burnaby, Canada
Research Site
Edmonton, Canada
...and 25 more locations
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
Time frame: Assessed at 12 months
Change from baseline in total hip BMD
Time frame: Assessed at 12 and 24 months
Change from baseline in lumbar spine (L1-L4) BMD
Time frame: Assessed at 24 months
Change from baseline in bone formation markers
Time frame: Assessed at 6 and12 months
Change from baseline in bone resorption and formation markers
Time frame: Assessed at 6 and 12 months
Change from baseline in LDL-cholesterol
Time frame: Assessed at 12 months
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides
Time frame: Assessed at 3, 6 and 12 months
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