Effect of Aromatase Inhibitors on Bones and Genes

Completed · Not applicable

Conditions studied: Breast Cancer, Postmenopausal

In brief

The primary objective of this 2-year pilot project is to test the hypothesis that skeletal response to aromatase inhibitors is determined by polymorphisms of the CYP19 gene.

Key facts

Study ID

NCT00603967

Run by

Washington University School of Medicine

People needed

151

Starts

2006-03-01

Expected to finish

2009-10-01

Last updated by the study team

2013-05-24

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal women aged greater than or equal to 40 years, at least 12 months from last menstrual period. For subjects who are amenorrheic for < 12 months (including patients who had hysterectomy, received ERT/HRT, or rendered amenorrheic by chemotherapy), they must have serum FSH =50 UI/L.
• Must have diagnosis of breast cancer stages I-IIIA.
• Planned therapy for the treatment group must include aromatase inhibitors using third generation non-steroidal aromatase inhibitors, anastrozole or letrozole. Those who are already treated with aromatase inhibitors and have bone density measurements prior to initiation of aromatase inhibitors or will be switched from tamoxifen to third generation aromatase inhibitors will also be included in the study.
• Bone mineral density measurement must range from normal to osteopenia (T-scores between +2.0/-2.0). Those with T-scores of <-2.0 in either the lumbar spine or the femoral neck as well as those with a history of osteoporosis-related fractures or vertebral deformities on lateral spine radiographs will be excluded from the study.
• Must be ambulatory willing and able to provide informed consent.

You may not qualify if…

• No current use of medications affecting bone metabolism, namely: estrogen, raloxifene, tamoxifen, bisphosphonates, GnRH analogues, glucocorticoids of at least 5 mg daily for 1 month or more, anabolic steroids and dilantin.
• No evidence of diseases known to interfere with bone metabolism, such as hyperparathyroidism, hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption, and immobilization.
• No current alcohol or tobacco abuse.
• No evidence of bone metastasis or evidence of abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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