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Keep this study
Lead
NCIC Clinical Trials Group
With
National Cancer Institute (NCI)
North Central Cancer Treatment Group
SWOG Cancer Research Network
OBJECTIVES:
* Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27.
OUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score\* ≥ -2.0 standard deviation \[SD\] \[no osteopenia or osteoporosis\] vs T-score\* \< -2.0 SD).
NOTE: \*The lowest of the two T-scores: L1-L4 or total hip
Blood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide \[P1NP\] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27).
Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy
PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
Age
45–120
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27
Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27
No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease
No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease
No other bone disease (including osteomalacia or osteogenesis imperfecta)
PRIOR CONCURRENT THERAPY:
More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)
More than 12 months since prior and no concurrent anticonvulsants
More than 6 months since prior and no concurrent corticosteroids at doses \> 5 mg/day of prednisone (or equivalent) for \> 2 weeks
More than 12 months since prior and no concurrent anabolic steroids
No prior bisphosphonates (stratum II)
No concurrent sodium fluoride at daily doses ≥ 5 mg/day
No long-term (i.e., \> 6 months) use of coumarins
No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis \[stratum I\])
