Arthralgia During Anastrozole Therapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00323479
First received: May 8, 2006
Last updated: March 13, 2012
Last verified: March 2012

May 8, 2006
March 13, 2012
June 2006
January 2009   (final data collection date for primary outcome measure)
Number of Participants With New Events of Arthralgia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To describe the joint symptoms and structural joint changes in women under anastrozole based on Visual Analogical Scale (VAS) score for global and hand pain and for global and hand handicap from baseline to 6 and 12 months
Complete list of historical versions of study NCT00323479 on ClinicalTrials.gov Archive Site
  • Functional Index of Cochin at 12 Months in Patients Under Anastrozole. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Results are based on 97 patients due to missing values
  • Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
  • Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    X ray assessment on hands and wrists based on 99 patients due to missing values
  • Percentage of Participant With Therapeutic Maintenance Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Treatment compliance. results based on 109 patients due to missing values
To assess the Score of Functional Index of Cochin + Articular and Synovitis Index, Dosage of bone and cartilage biomarkers, X-ray, sonographic measurements and description of personal and familial joint disorders, and characteristics of breast cancer
Not Provided
Not Provided
 
Arthralgia During Anastrozole Therapy for Breast Cancer
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Early Breast Cancer
Drug: Anastrozole
1mg/Day oral
Other Names:
  • ARIMIDEX
  • ZD1033
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00323479
D5392L00013, 2005-00-5441-19 EUDRACT number
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP