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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00784940
Enrollment
308
Registered
2008-11-04
Start date
1998-06-30
Completion date
2007-04-30
Last updated
2009-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Density

Brief summary

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.

Interventions

DRUGAnastrozole

1mg, orally, once daily

DRUGTamoxifen

20mg, orally, once daily

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to withdrawal—
Time to recurrence—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026