Arthralgia During Anastrozole Therapy for Breast Cancer

March 13, 2012 updated by: AstraZeneca

A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Research Site
      • Caen, France
        • Research Site
      • Lyon, France
        • Research Site
      • Paris, France
        • Research Site
      • Poitiers, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
  • WHO performance status 0, 1 or 2
  • Provision of written informed consent

Exclusion Criteria:

  • Recurrence of breast cancer, inflammatory rheumatism
  • treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
  • Diabetes treated by insulin
  • Severe renal or hepatic disease
  • Known hypersensitivity to anastrozole

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With New Events of Arthralgia
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
Time Frame: 12 months
Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.
12 months
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
Time Frame: 12 months
Results are based on 97 patients due to missing values
12 months
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
Time Frame: 12 months
X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values
12 months
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
Time Frame: 12 months
X ray assessment on hands and wrists based on 99 patients due to missing values
12 months
Percentage of Participant With Therapeutic Maintenance Under Anastrozole
Time Frame: 12 months
Treatment compliance. results based on 109 patients due to missing values
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5392L00013
  • 2005-00-5441-19 EUDRACT number

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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