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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122356
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Barwon Health

Tracking Information
First Submitted Date  ICMJE July 20, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date March 13, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: July 20, 2005)
Changes in lumbar vertebra and femoral neck BMD T-score after 5 years of anastrozole treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Alendronate sodium
70mg tablets, once weekly
Other Names:
  • Fosamax
  • Alendro
  • Adronat
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2010)
303
Original Enrollment  ICMJE
 (submitted: July 20, 2005)
300
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122356
Other Study ID Numbers  ICMJE ALCC 04.02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barwon Health
Study Sponsor  ICMJE Barwon Health
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Karen White Barwon Health
PRS Account Barwon Health
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP