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A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome

18 Years
Not Enrolling
Arthralgia Syndrome, Arthritis, Synovitis

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Trial Information

A Case Control Study to Define Clinical, Immunologic and Radiographic Features of the Aromatase Inhibitor Arthralgia Syndrome

This study is for women with post-menopausal breast cancer and hand pain. Patients do not
need to be taking aromatase inhibitors to be eligible for the study. We want to study the
joint findings in patients with hand pain and breast cancer undergoing treatment with
aromatase inhibitor medications and compare them to patients with hand pain and breast
cancer not treated with these medications.

Aromatase inhibitor drugs are used in certain types of breast cancer to reduce the risk of
cancer returning after treatment. One of the side effects of aromatase inhibitors is the
development of joint pain, a complication known as the Arthralgia Syndrome. The cause of the
Arthralgia Syndrome is not known, but we suspect that the pain may be due to inflammation in
the joints. Currently, the only effective treatment is to stop the aromatase inhibitor, and
so affected patients may miss out on an otherwise useful treatment to prevent return of
their cancer.

Post-menopausal patients with breast cancer and hand pain can enroll in the study. Patients
will be asked to come for a separate visit which will take about half a day.

Inclusion Criteria:

1. Postmenopausal women aged over 18 with stage I-III breast cancer undergoing treatment
at the Lombardi Cancer Center.

2. Presence of hand pain

3. No active signs of ongoing malignant disease

Exclusion Criteria:

1. Known autoimmune disease for example, rheumatoid arthritis, systemic lupus
erythematosis, polymyalgia rheumatica, or seronegative arthritis.

2. Age <18

3. Unable to complete informed consent process

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Difference in DAS-28 between cases and controls

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Victoria Shanmugam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University Hospital


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

May 2010

Related Keywords:

  • Arthralgia Syndrome
  • Arthritis
  • Synovitis
  • Arthritis
  • Synovitis
  • Aromatase Inhibitor
  • Arthralgia Syndrome
  • Arthralgia
  • Arthritis
  • Synovitis



Georgetown University Hospital Washington, District of Columbia  20007