Retrospective Survey of Bone Fracture in Patients With Ar... | NCT00859560

Studies
Retrospective Survey of Bone Fracture in Patients With Arimidex 1mg

NCT00859560

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 11, 2009Estimated

Enrollment

2,205Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

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

Status Module

Record Verification Date

Mar 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

Jan 2008

Primary Completion Date

Not provided

Completion Date

Dec 2008Actual

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

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

Mar 10, 2009

Last Update Posted Date

Mar 11, 2009Estimated

Description Module

Brief Summary

The retrospective survey is to investigate the incidence of bone fracture in post-menopausal breast cancer patients with Arimidex 1mg, who were previously registered for the clinical experience investigation.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,205Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone fracture incidence		Time since starting Arimidex

Secondary Outcomes

Measure	Description	Time Frame
Survival		Time since starting Arimidex
Bone density measurement		Time since starting Arimidex

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post-menopausal breast cancer patients treated with Arimidex 1mg at the time of previously conducted clinical experience investigation.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Post-menoposal breast cancer patients who were previousely registered in clinical experience investigation with Arimidex 1mg as adjuvant therapy.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
AstraZeneca Japan Medical Director MD	AstraZeneca	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided