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Trial record 7 of 7 for:    "Osteoporosis" | "Anastrozole"

Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

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ClinicalTrials.gov Identifier: NCT00111241
Recruitment Status : Completed
First Posted : May 19, 2005
Results First Posted : October 5, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Susan Davis, Monash University

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 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 or disease Intervention/treatment
Arthralgia Drug: aromatase inhibitors (letrozole, anastrozole)

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.


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Study Type : Observational
Actual Enrollment : 115 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: aromatase inhibitors (letrozole, anastrozole)
    Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study
    Other Name: no other names


Primary Outcome Measures :
  1. Knee Cartilage Volume [ Time Frame: Baseline, two years ]
    change in medial and lateral articular tibial cartilage volume over two years


Secondary Outcome Measures :
  1. Knee Subchondral Bone Expansion [ Time Frame: Baseline, Two years ]
    change in subchondral bone expansion area over two years



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111241


Locations
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Australia, Victoria
Women's Health Research Program, Monash University, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
Investigators
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Principal Investigator: Susan Davis, MBBS PhD Director Women's Health Program

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Responsible Party: Professor Susan Davis, Professor of Women's Health, Monash University
ClinicalTrials.gov Identifier: NCT00111241     History of Changes
Other Study ID Numbers: 2004/949
First Posted: May 19, 2005    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: December 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Anastrozole
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal