Anastrozole and Letrozole
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|ClinicalTrials.gov Identifier: NCT00762294|
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : December 15, 2011
Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast cancer. However, because these medications produce a marked reduction in serum estrogen levels, this is likely to result in an increased rate of bone loss and risk of developing osteoporosis and fractures in postmenopausal women treated with these agents. Indeed, substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis drugs are available that could prevent this loss, but they have frequent side effects and are expensive. Thus, treating all women receiving AIs might not be the most appropriate and cost-effective approach. A better approach might be to select women at highest risk of bone loss and only treat them with antiresorptive agents.
The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy, are receiving adequate amounts of calcium and vitamin D and have baseline normal or moderately low bone mass in order to determine if early changes in bone turnover markers correlate with bone loss at one year. If data from this pilot protocol support our hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to predict which women are at higher risk of bone loss and therefore treat them earlier with bone-sparing agents, while those with lower risk could be monitored on conservative therapy.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Women treated for breast cancer who will be starting Arimidex or Femara
- bone density [ Time Frame: baseline, 6 months, 12 months ]
- bone markers [ Time Frame: baseline, 1 month, 3 month, 6 month, 12 month ]
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): NCT00762294
|United States, Connecticut|
|University of Connecticut HEalth Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Pamela Taxel, MD||UConn Health|