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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2013

Intervention(s) in this Clinical Trial

• Drug: Alendronate sodium
  • 70mg tablets, once weekly

Primary Measures

• Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
  • Time Frame: 5 years
    Safety Issue?: Yes

Secondary Measures

• Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
  • Time Frame: 12 monthly intervals
    Safety Issue?: Yes
• Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
  • Time Frame: 6 months after registration and/or 6 months after commencing alendronate
    Safety Issue?: No
• Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
  • Time Frame: 5 years
    Safety Issue?: No
• Evaluate the clinical fracture incidence cumulative over 5 years
  • Time Frame: 5 years
    Safety Issue?: Yes
• Perform an economic analysis of the cost of monitoring and intervention
  • Time Frame: 5 years
    Safety Issue?: No
• Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
  • Time Frame: 5 years
    Safety Issue?: No
• Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
  • Time Frame: 6 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Barwon Health

Overall Clinical Trial Officials and Contacts

Richard Bell, MBBS (Hons) Principal Investigator Barwon Health  

Overall Contact: Elaine Yeow, BSc, MHumNutr 61-3-52267858 elainey@barwonhealth.org.au

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00122356

Study ID Number: ALCC 04.02

ClinicalTrials.gov Identifier: NCT00122356

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration