ATAC - Bone Density Sub-Protocol

Bone Density Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784940
• Other study ID #: 1033ID/0029
• Secondary ID: D5392C01985
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2008
• Last updated: April 24, 2009
• Start date: June 1998
• Est. completion date: April 2007

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBelgium: Ministry of Social Affairs, Public Health and the EnvironmentBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Institutional Ethical CommitteeFrance: Ministry of HealthFrance: National Consultative Ethics Committee for Health and Life SciencesGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and ResearchGermany: German Institute of Medical Documentation and InformationGermany: Ministry of HealthNetherlands: Independent Ethics CommitteeNetherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)Netherlands: Medicines Evaluation Board (MEB)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)South Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilSweden: Institutional Review BoardSweden: Medical Products AgencySweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical EthicsSweden: Swedish Research CouncilSweden: The National Board of Health and WelfareUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: April 2007
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Bone Density

Intervention

Drug:
• Anastrozole
1mg, orally, once daily
• Tamoxifen
20mg, orally, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to withdrawal			No
Primary	Time to recurrence			No