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

• ClinicalTrials.gov Identifier: NCT00122356
• Recruitment Status: Completed
• First Posted: July 22, 2005
• Last Update Posted: March 13, 2013
• Sponsor: Barwon Health
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): Barwon Health

Tracking Information

• First Submitted Date: July 20, 2005
• First Posted Date: July 22, 2005
• Last Update Posted Date: March 13, 2013
• Study Start Date: September 2005
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 14, 2008): Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment [ Time Frame: 5 years ]
• Original Primary Outcome Measures (submitted: July 20, 2005): Changes in lumbar vertebra and femoral neck BMD T-score after 5 years of anastrozole treatment.

Current Secondary Outcome Measures (submitted: August 14, 2008)

• Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD [ Time Frame: 12 monthly intervals ]
• 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 ]
• Evaluate the Osteoporosis Australia strategy for bone protection for this patient group [ Time Frame: 5 years ]
• Evaluate the clinical fracture incidence cumulative over 5 years [ Time Frame: 5 years ]
• Perform an economic analysis of the cost of monitoring and intervention [ Time Frame: 5 years ]
• Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy [ Time Frame: 5 years ]
• Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy [ Time Frame: 6 months ]

Original Secondary Outcome Measures (submitted: July 20, 2005)

• - Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD at 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
• - Evaluate the clinical fracture incidence cumulative over 5 years
• - Perform an economic analysis of the cost of monitoring and intervention
• - Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
• - Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Breast Cancer

Intervention

Drug: Alendronate sodium

70mg tablets, once weekly

Other Names:

• Fosamax
• Alendro
• Adronat

Study Arms

Anastrozole and alendronate

Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.

Intervention: Drug: Alendronate sodium

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2010): 303
• Original Enrollment (submitted: July 20, 2005): 300
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00122356
• Other Study ID Numbers: ALCC 04.02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Barwon Health
• Original Responsible Party: Not Provided
• Current Study Sponsor: Barwon Health
• Original Study Sponsor: Same as current
• Collaborators: AstraZeneca

Investigators

• Principal Investigator: Karen White; Barwon Health

• PRS Account: Barwon Health
• Verification Date: March 2013