Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00111241




Registration number
NCT00111241
Ethics application status
Date submitted
18/05/2005
Date registered
19/05/2005
Date last updated
14/12/2018

Titles & IDs
Public title
Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors
Scientific title
Assessment of Knee Joint Articular Cartilage Volume Change, Bone Loss and Change in Body Composition in Women Treated With Anastrozole or Letrozole and Comparison With Untreated Controls
Secondary ID [1] 0 0
2004/949
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthralgia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - aromatase inhibitors (letrozole, anastrozole)

Treatment: Drugs: aromatase inhibitors (letrozole, anastrozole)
Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Knee Cartilage Volume
Timepoint [1] 0 0
Baseline, two years
Secondary outcome [1] 0 0
Knee Subchondral Bone Expansion
Timepoint [1] 0 0
Baseline, Two years

Eligibility
Key inclusion criteria
Group 1 :

- Aged 40 - 65

- Non-hysterectomised women who have undergone breast surgery

- Women on aromatase inhibitors within preceding 12 weeks

Group 2 : control group

- Healthy, non-hysterectomised women aged 40-65 .
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous knee injury requiring non-weight bearing treatment for > 24 hrs or surgery
(including arthroscopy)

- Inability to complete the study (eg proposed relocation)

- Contraindication to undergoing an MRI including pacemaker, metal sutures, presence of
shrapnel, iron filings in eye

- Claustrophobia

Additional Exclusions for Group 1

- Treatment with tamoxifen for > 8 weeks prior to commencement

- Knee pain lasting for >24 hours in the last 5 years (prior to commencement on
anastrozole or letrozole)

- Anastrazole or Letrozole therapy for > 12 weeks

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Women's Health Research Program, Monash University, The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Many women with breast cancer are treated with a class of drugs called aromatase inhibitors
(mainly letrozole or anastrozole), which lowers the amount of estrogen being produced in the
body. Women on aromatase inhibitors appear to experience joint pains and arthralgia. The aim
of this study is to determine whether the joint pains experienced by some women on aromatase
inhibitors is associated with more defects in their cartilage, compared to women not
receiving this therapy. Using the magnetic resonance imaging (MRI) technique, the knee joint
will be examined to assess changes in cartilage volume over time.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00111241
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan Davis, MBBS PhD
Address 0 0
Director Women's Health Program
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00111241