Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-00-5441-19 EUDRACT number |
Not provided
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug | 1mg/Day oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New Events of Arthralgia | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Index of Cochin at 12 Months in Patients Under Anastrozole. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca France Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bordeaux | France | ||||
| Research Site |
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)
Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Anastrozole 1 mg | Anastrozole 1 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Anastrozole 1 mg | Anastrozole 1 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With New Events of Arthralgia | Posted | Number | Participants | 12 months |
|
|
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110 participants were included in the safety population, those who had taken at least one dose of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anastrozole 1 mg | Anastrozole 1 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death unexplained | General disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
Not provided
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| Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole |
Results are based on 97 patients due to missing values |
| 12 months |
| Kellgren and Lawrence Score 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 | 12 months |
| Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole | X ray assessment on hands and wrists based on 99 patients due to missing values | 12 months |
| Percentage of Participant With Therapeutic Maintenance Under Anastrozole | Treatment compliance. results based on 109 patients due to missing values | 12 months |
| Caen |
| France |
| Research Site | Lyon | France |
| Research Site | Paris | France |
| Research Site | Poitiers | France |
| house moving |
|
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Functional Index of Cochin at 12 Months in Patients Under Anastrozole. | 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. | Posted | Mean | Standard Deviation | Units on scale | 12 months |
|
|
|
| Secondary | Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole | Results are based on 97 patients due to missing values | Posted | Mean | Standard Deviation | Ng/mL | 12 months |
|
|
|
| Secondary | Kellgren and Lawrence Score 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 | Posted | Mean | Standard Deviation | Units on scale | 12 months |
|
|
|
| Secondary | Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole | X ray assessment on hands and wrists based on 99 patients due to missing values | Posted | Median | Standard Deviation | millimeter | 12 months |
|
|
|
| Secondary | Percentage of Participant With Therapeutic Maintenance Under Anastrozole | Treatment compliance. results based on 109 patients due to missing values | Posted | Number | percentage of participants | 12 months |
|
|
|
| 6 |
| 110 |
| 106 |
| 110 |
| Lymphangitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Calculus urinary bladder | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
|
| Depression worsened | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| General body pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Parathyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| hot flush | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| musculosketal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| breast fibrosis | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| breast oedema | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| breast pain | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| lymphoedema | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D009140 | Musculoskeletal Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |