Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

• Status: Completed
• Trial end date: 2012-01-06
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.

PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborators: National Cancer Institute (NCI); North Central Cancer Treatment Group; Southwest Oncology Group
• Treatments: Alendronate; Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Risedronate Sodium; Risedronic Acid

Criteria

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

• Hormone receptor status:

• Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Female

• Postmenopausal

• No malabsorption syndrome

• 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])