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Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment (BATMAN)

This study has been completed.
Information provided by (Responsible Party):
Barwon Health Identifier:
First received: July 20, 2005
Last updated: March 11, 2013
Last verified: March 2013
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.

Condition Intervention Phase
Breast Cancer
Drug: Alendronate sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Barwon Health:

Primary Outcome Measures:
  • Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD [ Time Frame: 12 monthly intervals ]
  • 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 ]
  • Evaluate the Osteoporosis Australia strategy for bone protection for this patient group [ Time Frame: 5 years ]
  • Evaluate the clinical fracture incidence cumulative over 5 years [ Time Frame: 5 years ]
  • Perform an economic analysis of the cost of monitoring and intervention [ Time Frame: 5 years ]
  • Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy [ Time Frame: 5 years ]
  • Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy [ Time Frame: 6 months ]

Enrollment: 303
Study Start Date: September 2005
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Anastrozole and alendronate
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
Drug: Alendronate sodium
70mg tablets, once weekly
Other Names:
  • Fosamax
  • Alendro
  • Adronat


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts 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
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Please refer to this study by its identifier: NCT00122356

Australia, New South Wales
Sydney South West Area Health Service
Sydney, New South Wales, Australia, 2050
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Maroondah Breast Clinic
East Ringwood, Victoria, Australia, 3135
St Vincent's Health
Fitzroy, Victoria, Australia, 3065
Barwon Health
Geelong, Victoria, Australia, 3220
St John of God Healthcare
Geelong, Victoria, Australia, 3220
South West Healthcare
Warrnambool, Victoria, Australia, 3280
Sponsors and Collaborators
Barwon Health
Principal Investigator: Karen White Barwon Health
  More Information

Responsible Party: Barwon Health Identifier: NCT00122356     History of Changes
Other Study ID Numbers: ALCC 04.02
Study First Received: July 20, 2005
Last Updated: March 11, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 24, 2017