The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
303
70mg tablets, once weekly
Sydney South West Area Health Service
Sydney, New South Wales, Australia
Tweed Hospital
Tweed Heads, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Maroondah Breast Clinic
East Ringwood, Victoria, Australia
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Time frame: 5 years
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Time frame: 12 monthly intervals
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
Time frame: 6 months after registration and/or 6 months after commencing alendronate
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Time frame: 5 years
Evaluate the clinical fracture incidence cumulative over 5 years
Time frame: 5 years
Perform an economic analysis of the cost of monitoring and intervention
Time frame: 5 years
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Time frame: 5 years
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Time frame: 6 months
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St Vincent's Health
Fitzroy, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
St John of God Healthcare
Geelong, Victoria, Australia
South West Healthcare
Warrnambool, Victoria, Australia