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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00122356




Registration number
NCT00122356
Ethics application status
Date submitted
20/07/2005
Date registered
22/07/2005
Date last updated
13/03/2013

Titles & IDs
Public title
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Scientific 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
Secondary ID [1] 0 0
ALCC 04.02
Universal Trial Number (UTN)
Trial acronym
BATMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alendronate sodium

Other: Anastrozole and alendronate - Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.


Treatment: Drugs: Alendronate sodium
70mg tablets, once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Timepoint [1] 0 0
12 monthly intervals
Secondary outcome [2] 0 0
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
Timepoint [2] 0 0
6 months after registration and/or 6 months after commencing alendronate
Secondary outcome [3] 0 0
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Evaluate the clinical fracture incidence cumulative over 5 years
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Perform an economic analysis of the cost of monitoring and intervention
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Timepoint [7] 0 0
6 months

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney South West Area Health Service - Sydney
Recruitment hospital [2] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Maroondah Breast Clinic - East Ringwood
Recruitment hospital [5] 0 0
St Vincent's Health - Fitzroy
Recruitment hospital [6] 0 0
Barwon Health - Geelong
Recruitment hospital [7] 0 0
St John of God Healthcare - Geelong
Recruitment hospital [8] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3280 - Warrnambool

Funding & Sponsors
Primary sponsor type
Government body
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00122356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen White
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00122356