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Sponsors and Collaborators: |
University of Connecticut Health Center Connecticut Breast Health Initiative |
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Information provided by: | University of Connecticut Health Center |
ClinicalTrials.gov Identifier: | NCT00762294 |
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 |
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Breast Cancer |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
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 |
Estimated Enrollment: | 25 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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644-001
Women treated for breast cancer who will be starting Arimidex or Femara
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women receiving treatment for breast cancer, who will be starting Arimidex or Femara
Inclusion Criteria:
Exclusion Criteria:
Contact: Paula Gendreau, RN | 860-679-8074 ext 8074 | Gendreau@nso.uchc.edu |
Contact: Pamela Taxel, MD | 860-679-4743 ext 4743 | Taxel@nso.uchc.edu |
United States, Connecticut | |
University of Connecticut HEalth Center | Recruiting |
Farmington, Connecticut, United States, 06030 | |
Contact: paula Gendreau, RN 860-679-8074 ext 8074 Gendreau@nso.uchc.edu | |
Principal Investigator: Pamela Taxel, MD |
Principal Investigator: | Pamela Taxel, MD | University of Connecticut Health Center |
Responsible Party: | University of Connecticut Health Center ( Pamela Taxel, MD ) |
Study ID Numbers: | 07-043-2, GCRC # 644 |
Study First Received: | September 26, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00762294 History of Changes |
Health Authority: | United States: Institutional Review Board |
breast cancer arimidex femara bone health |
Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Breast Neoplasms |
Letrozole Aromatase Inhibitors Breast Diseases |
Anastrozole Skin Diseases Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Breast Diseases |