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Trial registered on ANZCTR


Registration number
ACTRN12605000003673
Ethics application status
Approved
Date submitted
8/07/2005
Date registered
8/07/2005
Date last updated
24/06/2010
Type of registration
Retrospectively registered

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] 85 0
Andrew Love Cancer Centre: ALCC 04.02
Universal Trial Number (UTN)
Trial acronym
BATMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 65 0
Condition category
Condition code
Cancer 77 77 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to assess the utility, through DEXA scans and biochemical markers of bone turnover, of a strategy of monitoring and intervention with oral alendronate in postmenopausal women with hormone-receptor positive breast cancer receiving five years of adjuvant anastrozole. It specifically addressed the issues of osteopaenic and osteoporotic women in this setting and will test three years versus five years of alendronate use.
Intervention code [1] 5 0
Treatment: Drugs
Comparator / control treatment
Five years of treatment with 70mg oral alendronate once weekly
Control group
Active

Outcomes
Primary outcome [1] 109 0
Changes in lumbar vertebra and femoral neck BMD T-score after 5 years of anastrozole treatment
Timepoint [1] 109 0
After 5 years of anastrozole treatment
Secondary outcome [1] 244 0
Percent change in the lumbar vertebrae
Timepoint [1] 244 0
Annually for 5 years
Secondary outcome [2] 245 0
Biochemical markers
Timepoint [2] 245 0
6 months after commencing alendronate
Secondary outcome [3] 246 0
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group.
Timepoint [3] 246 0
At 5 years

Eligibility
Key inclusion criteria
Postmenopausal women- Adequately diagnosed and treated Stage I-IIIa early breast cancer- Oestrogen receptor and/or progesterone receptor positive breast cancer- Anastrozole is clinically indicated to be the best adjuvant strategy
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical or radiological evidence of distant spread- prior treatment with bisphosphonates within the past 12 months

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)
central randomisation via fax and phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 107 0
Commercial sector/Industry
Name [1] 107 0
Astra Zeneca
Address [1] 107 0
P.O Box 131, North Ryde PBC NSW 1670
Country [1] 107 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
272-322 Ryrie Street, Geelong, Victoria 3220
Country
Australia
Secondary sponsor category [1] 82 0
None
Name [1] 82 0
Nil
Address [1] 82 0
Nil
Country [1] 82 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 818 0
Barwon Health
Ethics committee address [1] 818 0
Ethics committee country [1] 818 0
Australia
Date submitted for ethics approval [1] 818 0
Approval date [1] 818 0
Ethics approval number [1] 818 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35785 0
Address 35785 0
Country 35785 0
Phone 35785 0
Fax 35785 0
Email 35785 0
Contact person for public queries
Name 9194 0
Ms Elaine Yeow
Address 9194 0
Andrew Love Cancer Centre
The Geelong Hospital
70 Swanston Street
Geelong VIC 3220
Country 9194 0
Australia
Phone 9194 0
+61 3 52267858
Fax 9194 0
+61 3 52465168
Email 9194 0
elainey@barwonhealth.org.au
Contact person for scientific queries
Name 122 0
Associate Professor Richard Bell
Address 122 0
Andrew Love Cancer Centre
The Geelong Hospital
70 Swanston Street
Geelong VIC 3220
Country 122 0
Australia
Phone 122 0
+61 3 52267855
Fax 122 0
+61 3 52465168
Email 122 0
richardb@barwonhealth.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary