BATMAN
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
Sponsor study identifier
interventional
303
1 country
8
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
March 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2005
Actual (reported)July 22, 2005
Actual (reported)September 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)March 2013
Actual (reported)Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
5 years
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
12 monthly intervals
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
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
Perform an economic analysis of the cost of monitoring and intervention
5 years
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
70mg tablets, once weekly
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Karen White
Barwon Health
303 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
South West Healthcare
Warrnambool, Victoria, 3280, Australia
Primary Completion
February 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
March 13, 2013
Record last verified: 2013-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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