Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
NCT ID: NCT00082277
Last Updated: 2011-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
237 participants
INTERVENTIONAL
2004-04-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
Anastrozole
1mg/Day Oral
Risedronate Sodium
35mg/week, oral
2
Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
Anastrozole
1mg/Day Oral
Risedronate Sodium
35mg/week, oral
3
Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
Anastrozole
1mg/Day Oral
Risedronate Sodium
35mg/week, oral
Interventions
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Anastrozole
1mg/Day Oral
Risedronate Sodium
35mg/week, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven operable invasive breast cancer
* Hormone-receptor-positive breast cancer
Exclusion Criteria
* Bilateral hip fractures or bilateral hip prosthesis
* Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
* Malabsorption syndrome
55 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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AstraZeneca Arimidex Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Cape Town, , South Africa
Research Site
Tygerberg, , South Africa
Research Site
Pamplona, , Spain
Research Site
Pontevedra, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Belfast, , United Kingdom
Research Site
Bolton, , United Kingdom
Research Site
Dundee, , United Kingdom
Research Site
Luton, , United Kingdom
Research Site
Bloemfontain, , South Africa
Research Site
Palm Springs, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
New Orleans, Louisiana, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Burnaby, , Canada
Research Site
Edmonton, , Canada
Research Site
Montreal, , Canada
Research Site
Québec, , Canada
Research Site
Vancouver, , Canada
Research Site
Bordeaux, , France
Research Site
Caen, , France
Research Site
Lyon, , France
Research Site
Saint-Cloud, , France
Research Site
Saint-Herblain, , France
Research Site
Athens, , Greece
Research Site
Irakleio, , Greece
Research Site
Goes, , Netherlands
Research Site
Ijssel, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
The Hague, , Netherlands
Countries
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References
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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Other Identifiers
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SABRE
Identifier Type: -
Identifier Source: secondary_id
D5392C00050
Identifier Type: -
Identifier Source: org_study_id
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