ATAC - Bone Density Sub-Protocol
Study identifier:1033ID/0029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Metabolism of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, (in Comparison to a Control Group) when used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women
Medical condition
Bone Density
Phase
Phase 3
Healthy volunteers
No
Study drug
Anastrozole, Tamoxifen
Sex
Female
Actual Enrollment
308
Study type
Interventional
Age
45 Years +
Date
Study Start Date: 01 Jun 1998
Primary Completion Date: 01 Mar 2005
Study Completion Date: 01 Apr 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Apr 2009 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Arimidex 1mg + Nolvadex placebo | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex |
| Active Comparator: 2 Arimidex placebo + Nolvadex 20mg | Drug: Anastrozole 1mg, orally, once daily Other Name: Arimidex Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
| Active Comparator: 3 Arimidex 1mg + Nolvadex 20mg | Drug: Tamoxifen 20mg, orally, once daily Other Name: Nolvadex |
