Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors (NCT00111241) | Clinical Trial Compass
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 range
40 Years – 65 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.