ATAC - Bone Density Sub-Protocol | NCT00784940

Studies
ATAC - Bone Density Sub-Protocol

NCT00784940

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 27, 2009Estimated

Enrollment

308Actual

Phase

Phase 3

Conditions

Bone Density

Interventions

Anastrozole
Tamoxifen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D5392C01985

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

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1998

Primary Completion Date

Mar 2005Actual

Completion Date

Apr 2007Actual

First Submitted Date

Nov 3, 2008

First Submission Date that Met QC Criteria

Nov 3, 2008

First Posted Date

Nov 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2009

Last Update Posted Date

Apr 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Arimidex 1mg + Nolvadex placebo	Drug: Anastrozole
2	Active Comparator	Arimidex placebo + Nolvadex 20mg	Drug: Anastrozole Drug: Tamoxifen
3	Active Comparator	Arimidex 1mg + Nolvadex 20mg	Drug: Tamoxifen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anastrozole	Drug	1mg, orally, once daily	1 2	Arimidex

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole
D013629	Tamoxifen

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Time to withdrawal
Time to recurrence