Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2013-03-31

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Anastrozole and alendronate

Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.

Group Type OTHER

Alendronate sodium

Intervention Type DRUG

70mg tablets, once weekly

Interventions

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Alendronate sodium

70mg tablets, once weekly

Intervention Type DRUG

Other Intervention Names

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Fosamax Alendro Adronat

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No