ArthralgiaNCT00111241
Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors
An observational study of Arthralgia, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Arthralgia
- What is being tested?
- aromatase inhibitors (letrozole, anastrozole)
- How many people
- 115 participants
- Where
- 1 siteAustralia
- Study dates
- May 2005to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be informed of study by their treating physician and invited to participate and by community sample.
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Women's Health Research Program, Monash University, The Alfred Hospital
Melbourne, Victoria, 3004
About this study
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
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.
Read the 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.
- Conditions
- Arthralgia
- Being tested
- aromatase inhibitors (letrozole, anastrozole)
- Keywords
- bone fracture, cartilage, osteoporosis, breast cancer, aromatase inhibitors, knee articular cartilage volume
- Medical subject headings
- Arthralgia, Fractures, Bone, Osteoporosis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatase inhibitors (letrozole, anastrozole)Drug
Also called no other names
Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Cartilage Volume
change in medial and lateral articular tibial cartilage volume over two years
Measured: Baseline, two years
Secondary outcomes (1)
Knee Subchondral Bone Expansion
change in subchondral bone expansion area over two years
Measured: Baseline, Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Susan Davis, Monash University
- Investigators
- Susan Davis, MBBS PhD, Principal investigator, Director Women's Health Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111241
- Sponsor's protocol ID
- 2004/949
- Status last verified
- Nov 2018
- First submitted
- 18 May 2005
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00111241
- Acronym / sponsor ID
- 2004/949
- Conditions
- Arthralgia
- Keywords
- bone fracture, cartilage, osteoporosis, breast cancer, aromatase inhibitors, knee articular cartilage volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 May 2005 (estimated)
- Results
- Posted 5 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be informed of study by their treating physician and invited to participate and by community sample.
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatase inhibitors (letrozole, anastrozole)Also: no other namesWomen prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study | Drug | – |
Primary outcome
Knee Cartilage Volume
Time frame: Baseline, two years
change in medial and lateral articular tibial cartilage volume over two years
1 secondary outcome
Knee Subchondral Bone Expansion
Time frame: Baseline, Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Davis, MBBS PhD principal investigator
Director Women's Health Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthralgia, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Cartilage Volume (time frame: Baseline, two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.