Spots Global Cancer Trial Database for Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
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Trial Identification
Brief Title: Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
Official Title: A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated
Study ID: NCT00082277
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
Detailed Description:
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Quebec City, , 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, Iraklion, , Greece
Research Site, Den Haag, , Netherlands
Research Site, Goes, , Netherlands
Research Site, Ijssel, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Bloemfontain, , South Africa
Research Site, Cape Town, , South Africa
Research Site, Tygerberg, , South Africa
Research Site, Pamplona, , Spain
Research Site, Pontevedra, , Spain
Research Site, Sevilla, , 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
Contact Details
Name: AstraZeneca Arimidex Medical Science Director, MD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
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