Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
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
1 other identifier
interventional
303
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Sep 2005
Typical duration for phase_3 breast-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 13, 2013
March 1, 2013
7.4 years
July 20, 2005
March 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
5 years
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Anastrozole and alendronate
OTHERPatients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
Interventions
70mg tablets, once weekly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barwon Healthlead
- AstraZenecacollaborator
Study Sites (8)
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
Related Publications (1)
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.
PMID: 38979716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen White
Barwon Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
March 13, 2013
Record last verified: 2013-03