Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment (BATMAN)
This study has been completed.
Sponsor:
Barwon Health
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Barwon Health
ClinicalTrials.gov Identifier:
NCT00122356
First received: July 20, 2005
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Alendronate sodium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Barwon Health:
Primary Outcome Measures:
- Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD [ Time Frame: 12 monthly intervals ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Evaluate the Osteoporosis Australia strategy for bone protection for this patient group [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluate the clinical fracture incidence cumulative over 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Perform an economic analysis of the cost of monitoring and intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 303 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Anastrozole and alendronate
Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
|
Drug: Alendronate sodium
70mg tablets, once weekly
Other Names:
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122356
Locations
| Australia, New South Wales | |
| Sydney South West Area Health Service | |
| Sydney, New South Wales, Australia, 2050 | |
| Tweed Hospital | |
| Tweed Heads, New South Wales, Australia, 2485 | |
| Australia, Victoria | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia, 3128 | |
| Maroondah Breast Clinic | |
| East Ringwood, Victoria, Australia, 3135 | |
| St Vincent's Health | |
| Fitzroy, Victoria, Australia, 3065 | |
| Barwon Health | |
| Geelong, Victoria, Australia, 3220 | |
| St John of God Healthcare | |
| Geelong, Victoria, Australia, 3220 | |
| South West Healthcare | |
| Warrnambool, Victoria, Australia, 3280 | |
Sponsors and Collaborators
Barwon Health
AstraZeneca
Investigators
| Principal Investigator: | Karen White | Barwon Health |
More Information
No publications provided
| Responsible Party: | Barwon Health |
| ClinicalTrials.gov Identifier: | NCT00122356 History of Changes |
| Other Study ID Numbers: | ALCC 04.02 |
| Study First Received: | July 20, 2005 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Alendronate Anastrozole Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013