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Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Monash University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT00111241
First received: May 18, 2005
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Arthralgia
Drug: aromatase inhibitors (letrozole, anastrozole)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official 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

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Knee cartilage volume [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menopausal symptoms [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Well-being [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: May 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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 joint pain amongst women on aromatase inhibitors is not understood.

Using magnetic resonance imaging (MRI) to measure knee articular cartilage volume, we have demonstrated that post menopausal hormone therapy used for at least five years is associated with retention of articular cartilage in the knee, indicating that oestrogen may protect against the development of osteoarthritis in post menopausal women. Furthermore, we have recently observed that free testosterone is associated with loss of tibial cartilage, after taking into account age, body mass index, baseline tibial cartilage volume, tibial plateau area and total bone mineral content in healthy men. Whether an excess of testosterone to oestrogen as a consequence of aromatase inhibition has an adverse effect on articular cartilage volume warrants further investigation.

This study will include non-hysterectomised women aged 40 to 65 years who have undergone breast surgery and then commenced on aromatase inhibitors within the preceding 12 weeks. The control group (which has been fully recruited) included non-hysterectomised, healthy women aged 40 to 65 years. A MRI of the dominant knee will be used to compare changes in knee articular volume over time. A MRI will be done at baseline and again at 2 years. Changes in knee articular volume is the primary outcome. We will also use this opportunity to compare menopausal symptoms (assessed using the Menopause Quality of Life [MENQOL] questionnaire) between women treated with aromatase inhibitors and those who are not. Well-being will also be assessed using the Psychological General Well-Being index.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be informed of study by their treating physician and invited to participate and by community sample.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111241

Locations
Australia, Victoria
Women's Health Program, Monash University
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Susan Davis, MBBS FRACP PhD Director Women's Health Program
  More Information

No publications provided

Responsible Party: Professor Susan Davis, Women's Health Program
ClinicalTrials.gov Identifier: NCT00111241     History of Changes
Other Study ID Numbers: 2004/949
Study First Received: May 18, 2005
Last Updated: September 17, 2009
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Monash University:
bone fracture
cartilage
osteoporosis
breast cancer
aromatase inhibitors
knee articular cartilage volume

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Anastrozole
Aromatase Inhibitors
Letrozole
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014