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

NCIC Clinical Trials Group

Status and phase

Completed

Phase 3

Conditions

Osteoporosis

Breast Cancer

Treatments

Drug: calcium gluconate

Drug: alendronate sodium

Dietary Supplement: cholecalciferol

Other: laboratory biomarker analysis

Dietary Supplement: calcium carbonate

Dietary Supplement: calcium citrate

Procedure: dual x-ray absorptometry

Drug: risedronate sodium

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00354302

CDR0000483099 (Other Identifier)

NCCTG-NCIC-MA27B (Other Identifier)

SWOG-NCIC-MA27B (Other Identifier)

CAN-NCIC-MA27B (Registry Identifier)

MA27B

CAN-NCIC-BONE

Details and patient eligibility

About

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.

Full description

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.

Enrollment

497 patients

Sex

Female

Ages

45 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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])