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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer

Conditions
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Breast Cancer, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: calcium carbonate
* Dietary Supplement: calcium citrate
* Dietary Supplement: cholecalciferol
* Drug: alendronate sodium
* Drug: calcium gluconate
* Drug: risedronate sodium
* Other: laboratory biomarker analysis
* Procedure: dual x-ray absorptometry


Participation Criteria
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Eligibility Criteria
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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])

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: calcium carbonate|nan|
|Dietary Supplement: calcium citrate|nan|
|Dietary Supplement: cholecalciferol|nan|
|Drug: alendronate sodium|nan|
|Drug: calcium gluconate|nan|
|Drug: risedronate sodium|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: dual x-ray absorptometry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in BMD at 5 years (from baseline) |  | 5 years | 
| Mean percentage change in BMD at 1, 3, and 5 years (from baseline) |  | 5 years | 
| Proportion of patients without osteopenia or osteoporosis (stratum I) who develop BMD below the absolute threshold for osteopenia (< -2.0 standard deviation below the mean), suffer any osteoporotic fracture, or have an asymptomatic fracture revealed ... |  | 5 years | 
| Percentage of patients with osteopenia or osteoporosis (stratum II) who have ≥ 5% improvement of BMD at 2 years post randomization on protocol CAN-NCIC-MA27 and who have clinically apparent osteoporosis-related fracture of the long bones |  | 5 years | 
| Pattern of change in bone biomarkers from baseline |  | 5 years | 
| Clinical safety and tolerability of study medications |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer