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Arthralgia During Anastrozole Therapy for Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323479
First Posted: May 9, 2006
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Early Breast Cancer Drug: Anastrozole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants With New Events of Arthralgia [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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.

  • 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

  • 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

  • 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

  • Percentage of Participant With Therapeutic Maintenance Under Anastrozole [ Time Frame: 12 months ]
    Treatment compliance. results based on 109 patients due to missing values


Enrollment: 114
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anastrozole
    1mg/Day oral
    Other Names:
    • ARIMIDEX
    • ZD1033
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323479


Locations
France
Research Site
Bordeaux, France
Research Site
Caen, France
Research Site
Lyon, France
Research Site
Paris, France
Research Site
Poitiers, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00323479     History of Changes
Other Study ID Numbers: D5392L00013
2005-00-5441-19 EUDRACT number
First Submitted: May 8, 2006
First Posted: May 9, 2006
Results First Submitted: January 26, 2010
Results First Posted: April 6, 2012
Last Update Posted: April 6, 2012
Last Verified: March 2012

Keywords provided by AstraZeneca:
breast cancer treatment
joint disorders

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs