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Completed

NCT Number: NCT00323479

Arthralgia During Anastrozole Therapy for 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.

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Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1mg/Day oral

Other names: ARIMIDEX, ZD1033

Primary outcomes

  1. Number of Participants With New Events of Arthralgia

    Time frame: 12 months

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Percentage of Participant With Therapeutic Maintenance Under Anastrozole

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 9, 2006
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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