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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00082277 |
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.
Condition | Intervention | Phase |
Breast Cancer |
Drug: Anastrozole Drug: Risedronate Sodium |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Fractures |
ChemIDplus related topics: | Anastrozole Risedronate sodium Risedronic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 237 |
Study Start Date: | October 2002 |
Study Completion Date: | November 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
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Drug: Anastrozole
1mg/Day Oral
Drug: Risedronate Sodium
35mg/week, oral
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2: Experimental
Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
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Drug: Anastrozole
1mg/Day Oral
Drug: Risedronate Sodium
35mg/week, oral
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3: Experimental
Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
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Drug: Anastrozole
1mg/Day Oral
Drug: Risedronate Sodium
35mg/week, oral
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Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 35 Study Locations |
AstraZeneca |
Study Director: | AstraZeneca Arimidex Medical Science Director, MD | AstraZeneca |
Responsible Party: | AstraZeneca ( Francisco Sapunar, MD - Arimidex Medical Science Director ) |
Study ID Numbers: | D5392C00050, SABRE |
First Received: | May 5, 2004 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00082277 |
Health Authority: | United States: Food and Drug Administration |
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