## Protocol Section
### Identification Module
**NCT ID:** NCT00323479

**Brief Title:** Arthralgia During Anastrozole Therapy for Breast Cancer

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

#### Organization Study ID Info
**ID:** D5392L00013
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** 2005-00-5441-19 EUDRACT number
### Status Module
#### Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-04-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-03-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-04-06

**Type:** ESTIMATED

**Results First Submit Date:** 2010-01-26

**Results First Submit QC Date:** 2012-03-13

#### Start Date
**Date:** 2006-06

**Status Verified Date:** 2012-03

#### Study First Post Date
**Date:** 2006-05-09
**Type:** ESTIMATED
**Study First Submit Date:** 2006-05-08
**Study First Submit QC Date:** 2006-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

### Conditions Module

**Conditions:**

- Early Breast Cancer

**Keywords:**

- breast cancer treatment

- joint disorders

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 114

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 1mg/Day oral

**Name:** Anastrozole

**Other Names:**

- ARIMIDEX

- ZD1033

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Participants With New Events of Arthralgia

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Functional Index of Cochin at 12 Months in Patients Under Anastrozole.

**Time Frame:** 12 months

**Description:** Results are based on 97 patients due to missing values

**Measure:** Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole

**Time Frame:** 12 months

**Description:** 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

**Measure:** Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole

**Time Frame:** 12 months

**Description:** X ray assessment on hands and wrists based on 99 patients due to missing values

**Measure:** Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole

**Time Frame:** 12 months

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

**Measure:** Percentage of Participant With Therapeutic Maintenance Under Anastrozole

**Time Frame:** 12 months

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bordeaux

**Country:** France

**Facility:** Research Site

**Location 2:**

**City:** Caen

**Country:** France

**Facility:** Research Site

**Location 3:**

**City:** Lyon

**Country:** France

**Facility:** Research Site

**Location 4:**

**City:** Paris

**Country:** France

**Facility:** Research Site

**Location 5:**

**City:** Poitiers

**Country:** France

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** AstraZeneca

**Name:** AstraZeneca France Medical Director, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20833

- Name: Arthralgia

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6036

- Name: Menopause

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000047072

- Term: Aromatase Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000004965

- Term: Estrogen Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1781

- Name: Anastrozole

- Relevance: HIGH

- As Found: Targeting

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M25769

- Name: Aromatase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M8114

- Name: Estrogen Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30483

- Name: Estrogen Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077384

- Term: Anastrozole

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** 110 participants were included in the safety population, those who had taken at least one dose of treatment

#### Event Groups

**Group ID:** EG000

**Title:** Anastrozole 1 mg

**Description:** Anastrozole 1 mg once daily

**ID:** EG000

**Other Num Affected:** 106

**Other Num at Risk:** 110

**Serious Number Affected:** 6

**Serious Number At Risk:** 110

**Title:** Anastrozole 1 mg

**Frequency Threshold:** 5

#### Other Events

**Term:** arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 10.0

**Term:** hot flush

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** vertigo

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** musculoskeletal chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** musculosketal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** neck pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** breast fibrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** breast oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** breast pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** lymphoedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

#### Serious Events

**Term:** Sudden death unexplained

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Lymphangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Pneumopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Calculus urinary bladder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Depression worsened

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** General body pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Parathyroid adenoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 110

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 106

**Units:** Participants

### Group

**ID:** BG000

**Title:** Anastrozole 1 mg

**Description:** Anastrozole 1 mg once daily

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.87

**Value:** 62.87

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 106

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** year
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrialTransparency@astrazeneca.com
**Organization:** AstraZeneca
**Title:** Gerard Lynch
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.46
- **Upper Limit:** 
- **Value:** 4.32
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.28
- **Upper Limit:** 
- **Value:** 0.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13.64
- **Upper Limit:** 
- **Value:** 12.66
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.62
- **Upper Limit:** 
- **Value:** 1.77
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80.7
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Participants With New Events of Arthralgia
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 2
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 3
**Description:** Results are based on 97 patients due to missing values
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** Ng/mL
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 4
**Description:** 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
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 5
**Description:** X ray assessment on hands and wrists based on 99 patients due to missing values
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** millimeter
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 6
**Description:** Treatment compliance. results based on 109 patients due to missing values
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Percentage of Participant With Therapeutic Maintenance Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
### Participant Flow Module
#### Group
**Description:** Anastrozole 1 mg once daily
**ID:** FG000
**Title:** Anastrozole 1 mg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** house moving
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 114
##### Milestone
**Type:** Safety Population
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 110
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 106
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
**Pre-Assignment Details:** 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)
**Recruitment Details:** Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007
**Has Results:** True