Overview

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])