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OpenTrials
Completed

NCT Number: NCT00784940

ATAC - Bone Density Sub-Protocol

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.

Completed

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Key information

Conditions

Bone Density

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1mg, orally, once daily

Other names: Arimidex

Tamoxifen

Drug

20mg, orally, once daily

Other names: Nolvadex

Primary outcomes

  1. Time to withdrawal

  2. Time to recurrence

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2005
Study completion
2007
First posted
Nov 4, 2008
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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