Breast Cancer
Conditions
Brief summary
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.
Interventions
70mg tablets, once weekly
Sponsors
AstraZeneca
Barwon Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD | 12 monthly intervals |
| Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy | 6 months |
| 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 |
| 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 |
Countries
Australia
Outcome results
None listed