CompletedNot Applicable

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

Australia115 participantsStarted 2005-05

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 . 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

What they're measuring

Knee Cartilage Volume

Timeframe: Baseline, two years

Trial details

NCT IDNCT00111241

SponsorMonash University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-05

Results submitted2015-04-06