Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

Condition(s) targeted: Breast Cancer

Intervention: Alendronate sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Barwon Health

Official(s) and/or principal investigator(s):
Karen White, Principal Investigator, Affiliation: Barwon Health

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: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment

Secondary outcome:

Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD

Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD

Evaluate the Osteoporosis Australia strategy for bone protection for this patient group

Evaluate the clinical fracture incidence cumulative over 5 years

Perform an economic analysis of the cost of monitoring and intervention

Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy

Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Sydney South West Area Health Service, Sydney, New South Wales 2050, Australia

Tweed Hospital, Tweed Heads, New South Wales 2485, Australia

Box Hill Hospital, Box Hill, Victoria 3128, Australia

Maroondah Breast Clinic, East Ringwood, Victoria 3135, Australia

St Vincent's Health, Fitzroy, Victoria 3065, Australia

Barwon Health, Geelong, Victoria 3220, Australia

St John of God Healthcare, Geelong, Victoria 3220, Australia

South West Healthcare, Warrnambool, Victoria 3280, Australia

Starting date: September 2005
Last updated: March 11, 2013