Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Official Title
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A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Anastrozole
* Drug: Risedronate Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women defined as Postmenopausal Histologically proven operable invasive breast cancer Hormone-receptor-positive breast cancer Exclusion Criteria: Clinical evidence of metastatic disease Bilateral hip fractures or bilateral hip prosthesis Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens Malabsorption syndrome

Ages Eligible for Study
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Minimum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum | Drug: Anastrozole<br>* 1mg/Day Oral<br>* Other names: ZD1033;Drug: Risedronate Sodium<br>* 35mg/week, oral<br>* Other names: ACTONEL™;|
| Experimental: 2<br>Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum | Drug: Anastrozole<br>* 1mg/Day Oral<br>* Other names: ZD1033;Drug: Risedronate Sodium<br>* 35mg/week, oral<br>* Other names: ACTONEL™;|
| Experimental: 3<br>Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum | Drug: Anastrozole<br>* 1mg/Day Oral<br>* Other names: ZD1033;Drug: Risedronate Sodium<br>* 35mg/week, oral<br>* Other names: ACTONEL™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) |  | Assessed at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total hip BMD |  | Assessed at 12 and 24 months | 
| Change from baseline in lumbar spine (L1-L4) BMD |  | Assessed at 24 months | 
| Change from baseline in bone formation markers |  | Assessed at 6 and12 months | 
| Change from baseline in bone resorption and formation markers |  | Assessed at 6 and 12 months | 
| Change from baseline in LDL-cholesterol |  | Assessed at 12 months | 
| Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides |  | Assessed at 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone-receptor positive, breast cancer, Osteopenia, Osteoporosis, risk of fracture, bone loss