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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Barwon Health
ClinicalTrials.gov Identifier:
NCT00122356
First received: July 20, 2005
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD [ Time Frame: 12 monthly intervals ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Evaluate the Osteoporosis Australia strategy for bone protection for this patient group [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluate the clinical fracture incidence cumulative over 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Perform an economic analysis of the cost of monitoring and intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122356

Locations
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
AstraZeneca
Investigators
Principal Investigator: Karen White Barwon Health
  More Information

No publications provided

Responsible Party: Barwon Health
ClinicalTrials.gov Identifier: NCT00122356     History of Changes
Other Study ID Numbers: ALCC 04.02
Study First Received: July 20, 2005
Last Updated: March 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Alendronate
Anastrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014