Changes in Knee Articular Cartilage Volume in Women on Aromatase Inhibitors

NCT00111241 | Completed Results

• 1 other identifier: 2004/949
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthralgia

Keywords

bone fracture; cartilage; osteoporosis; breast cancer; aromatase inhibitors; knee articular cartilage volume

Outcome Measures

Primary Outcomes (1)

• Knee Cartilage Volume

  change in medial and lateral articular tibial cartilage volume over two years

  Baseline, two years

Secondary Outcomes (1)

• Knee Subchondral Bone Expansion

  Baseline, Two years

Interventions

aromatase inhibitors (letrozole, anastrozole) DRUG

Women prescribed an aromatase inhibitor by their clinician were compared with healthy controls in the community who had been recruited to a prior study

Also known as: no other names

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Women's Health Research Program, Monash University, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Arthralgia; Fractures, Bone; Osteoporosis; Breast Neoplasms

Interventions

Aromatase Inhibitors; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Menopausal Symptoms and Well-being were previously entered as Secondary Outcome Measures. Data not available to assess these outcomes.

Results Point of Contact

• Title: Prof Susan Davis
• Organization: Monash University

susan.davis@monash.edu

+61399030827

Study Officials

• Susan Davis, MBBS PhD

  Director Women's Health Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Women's Health

Study Record Dates

• First Submitted: May 18, 2005
• First Posted: May 19, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 14, 2018
• Results First Posted: October 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)