Status:

COMPLETED

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

Lead Sponsor:

Monash University

Conditions:

Arthralgia

Eligibility:

FEMALE

40-65 years

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 ...

Detailed Description

The mechanism of increased bone loss and fracture risk is clearly related to the depletion of estrogen production in the bone. But why there is a higher rate of reporting arthralgia, fracture and join...

Eligibility Criteria

Inclusion

  • 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 .

Exclusion

  • 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

Key Trial Info

Start Date :

May 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2011

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT00111241

Start Date

May 1 2005

End Date

December 1 2011

Last Update

December 14 2018

Active Locations (1)

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1

Women's Health Research Program, Monash University, The Alfred Hospital

Melbourne, Victoria, Australia, 3004