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Arthralgia During Anastrozole Therapy for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00323479
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Early Breast Cancer Drug: Anastrozole Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

Arms and Interventions
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Intervention Details:
  • Drug: Anastrozole
    1mg/Day oral
    Other Names:
    • ARIMIDEX
    • ZD1033

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

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Study Director: AstraZeneca France Medical Director, MD AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00323479    
Other Study ID Numbers: D5392L00013
2005-00-5441-19 EUDRACT number
First Posted: May 9, 2006    Key Record Dates
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:
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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