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
Phase 3
45 Years
N/A
45 Years
N/A
Not Enrolling
Female
Bone Density
Female
Bone Density
Trial Information
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
Inclusion Criteria:
- Eligible for entry into the main ATAC trial 1033IL/0029
- Women defined as post-menopausal
- Patients with histologically proven operable invasive breast cancer
- Who following primary surgery have a good prognosis and would be ethically suitable
to remain untreated
Exclusion Criteria:
- Excluded from entry into the main ATAC trial (1033IL/0029)
- Patients who have received hormone replacement therapy within the previous 12 months
prior to randomisation
- Patients who have received bisphosphonate therapy within the previous 12 months prior
to randomisation
- Patients who have had a bone fracture within the previous 6 months prior to
randomisation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Outcome Measure:
Time to withdrawal
Safety Issue:
No
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
1033ID/0029
NCT ID:
NCT00784940
Start Date:
June 1998
Completion Date:
April 2007
Related Keywords:
- Bone Density
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