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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Arthralgia during anastrozole therapy for breast cancer

Research Site

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

Age Continuous

Gender, Male/Female

Number of participants with new events of arthralgia

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.

Functional Index of Cochin at 12 months in patients under anastrozole.

Results are based on 97 patients due to missing values

Serum collagen degradation type I - CTX-I at 12 months in patients under anastrozole

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

Kellgren and Lawrence score at 12 months in patients under anastrozole

X ray assessment on hands and wrists based on 99 patients due to missing values

Synovial membrane thickness at 12 months in patients under anastrozole

Treatment compliance. results based on 109 patients due to missing values

Percentage of participant with therapeutic maintenance under anastrozole

Overall Study

Patients were included by an investigator-oncologist who followed them up every 3 months over a period of one year (i.e., 5 visits). An investigator rheumatologist carried out the rheumatological evaluations at inclusion and then every 6 months over a period of one year (i.e., 3 visits)

Arthralgia during anastrozole therapy for breast cancer

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=379&filename=CSR-D5392L00013.pdf

CSR-D5392L00013.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator