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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Alendronate sodium
Sponsored by
Barwon Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sydney South West Area Health Service
  • Tweed Hospital
  • Box Hill Hospital
  • Maroondah Breast Clinic
  • St Vincent's Health
  • Barwon Health
  • St John of God Healthcare
  • South West Healthcare

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anastrozole and alendronate

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment

Secondary Outcome Measures

Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
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

Full Information

First Posted
July 20, 2005
Last Updated
March 11, 2013
Sponsor
Barwon Health
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00122356
Brief Title
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Acronym
BATMAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barwon Health
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anastrozole and alendronate
Arm Type
Other
Arm Description
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
Intervention Type
Drug
Intervention Name(s)
Alendronate sodium
Other Intervention Name(s)
Fosamax, Alendro, Adronat
Intervention Description
70mg tablets, once weekly
Primary Outcome Measure Information:
Title
Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
Time Frame
12 monthly intervals
Title
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
Title
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
Time Frame
5 years
Title
Evaluate the clinical fracture incidence cumulative over 5 years
Time Frame
5 years
Title
Perform an economic analysis of the cost of monitoring and intervention
Time Frame
5 years
Title
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
Time Frame
5 years
Title
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen White
Organizational Affiliation
Barwon Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney South West Area Health Service
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Maroondah Breast Clinic
City
East Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
St Vincent's Health
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
St John of God Healthcare
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
South West Healthcare
City
Warrnambool
State/Province
Victoria
ZIP/Postal Code
3280
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

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