NCT00660244

Brief Summary

The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

First QC Date

April 15, 2008

Last Update Submit

June 5, 2012

Conditions

Post MenopausalArthralgia

Keywords

ArimidexPost menopausalarthralgia

Outcome Measures

Primary Outcomes (1)

  • Progression of disease and tolerability in general

    Baseline, every 3 month

Secondary Outcomes (1)

  • Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia

    Baseline, every 3 month

Study Arms (1)

1

Drug: anastrozole

Interventions

anastrozoleDRUG

Oral

Also known as: Arimidex
1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women

You may qualify if:

  • Postmenopausal women
  • Already on upfront Arimidex Therapy (Start 1-4 weeks before)
  • HR+

You may not qualify if:

  • Premenopausal women
  • Tamoxifen switch patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Graz, Austria

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dr. Melichart

    Hospital Rudolfstiftung

    STUDY CHAIR

  • Dr. Feistauer

    AKH-Vienna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

February 1, 2008

Study Completion

December 1, 2009

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

AU(1)