N/A
N=115
Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors
Arthralgia
Bottom Line
View on ClinicalTrials.gov: NCT00111241 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Knee Cartilage Volume — 2042; 1971 mm³
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- aromatase inhibitors (letrozole, anastrozole) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Monash University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Cartilage Volume |
2042; 1971 | — |
| SECONDARY Knee Subchondral Bone Expansion |
2020; 1992 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00111241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.