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Sponsors and Collaborators: |
Barwon Health AstraZeneca |
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Information provided by: | Barwon Health |
ClinicalTrials.gov Identifier: | NCT00122356 |
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 |
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Breast Cancer |
Drug: Alendronate sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elaine Yeow, BSc, MHumNutr | 61-3-52267858 | elainey@barwonhealth.org.au |
Australia, New South Wales | |
Sydney Cancer Institute | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Principal Investigator: Jane Beith | |
Tweed Hospital | Recruiting |
Tweed Heads, New South Wales, Australia, 2485 | |
Principal Investigator: Ehtesham Abdi | |
Australia, Victoria | |
Barwon Health | Recruiting |
Geelong, Victoria, Australia, 3220 | |
Contact: Elaine Yeow 61-3-52267858 elainey@barwonhealth.org.au | |
Principal Investigator: Richard Bell | |
Maroondah Breast Clinic | Recruiting |
East Ringwood, Victoria, Australia, 3135 | |
Principal Investigator: Jacquie Chirgwin | |
St John of God Healthcare | Recruiting |
Geelong, Victoria, Australia, 3220 | |
Sub-Investigator: Karen White | |
Box Hill Hospital | Recruiting |
Box Hill, Victoria, Australia, 3128 | |
Principal Investigator: Jacquie Chirgwin | |
St Vincent's Health | Recruiting |
Fitzroy, Victoria, Australia, 3065 | |
Principal Investigator: Raymond Snyder |
Principal Investigator: | Richard Bell, MBBS (Hons) | Barwon Health |
Responsible Party: | Barwon Health ( Associate Professor Richard Bell ) |
Study ID Numbers: | ALCC 04.02 |
Study First Received: | July 20, 2005 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00122356 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Anastrozole Diphosphonates Skin Diseases Alendronate |
Osteoporosis Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Bone Density Conservation Agents Aromatase Inhibitors Pharmacologic Actions |