Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.

Official Title
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Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Alendronate sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Adequately diagnosed and treated Stage I-IIIa early breast cancer Oestrogen receptor and/or progesterone receptor positive breast cancer Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration Any prior tamoxifen taken for a total of 8 weeks or less Any prior anastrozole taken for a total of 4 weeks or less Anastrozole is clinically indicated to be the best adjuvant strategy Signed written informed consent Exclusion Criteria: Clinical or radiological evidence of distant spread of disease Prior treatment with bisphosphonates within the past 12 months Prior treatment with continuous systemic corticosteroids within the past 12 months Prior use of parathyroid hormone for more than 1 week Prior use of systemic sodium fluoride for > 3 months during the past 2 years Currently treated with any drugs known to affect the skeleton Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L) History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded Delayed oesophageal emptying such as stricture or achalasia Hypersensitivity to alendronate or anastrozole Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix AST/SGOT and/or ALT/SGPT > 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency Fracture due to minimal trauma, demonstrated radiologically
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anastrozole and alendronate<br>Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years. | Drug: Alendronate sodium<br>* 70mg tablets, once weekly<br>* Other names: Adronat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD |  | 12 monthly intervals | 
| Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD |  | 6 months after registration and/or 6 months after commencing alendronate | 
| Evaluate the Osteoporosis Australia strategy for bone protection for this patient group |  | 5 years | 
| Evaluate the clinical fracture incidence cumulative over 5 years |  | 5 years | 
| Perform an economic analysis of the cost of monitoring and intervention |  | 5 years | 
| Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy |  | 5 years | 
| Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy |  | 6 months |