Clinical trial · Interventional
ATAC - Bone Density Sub-Protocol
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
NCT00784940CI-TRIAL-00002251completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Density | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Arimidex 1mg + Nolvadex placebo
- interventionNames
- Drug: Anastrozole
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Arimidex placebo + Nolvadex 20mg
- interventionNames
- Drug: Anastrozole
- Drug: Tamoxifen
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- Arimidex 1mg + Nolvadex 20mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.