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Anastrozole and Letrozole

NCT00762294 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2011-12-15

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Connecticut Breast Health Initiative

    collaborator OTHER

  • UConn Health

    lead OTHER

Principal Investigators

  • Pamela Taxel, MD · UConn Health

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00762294 on ClinicalTrials.gov