Anastrozole and Letrozole
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Purpose
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 |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: 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 |
- bone density [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: Yes ]
- bone markers [ Time Frame: baseline, 1 month, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
644-001
Women treated for breast cancer who will be starting Arimidex or Femara
|
Eligibility| 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:
- Postmenopausal women with diagnosis of breast cancer - have not started Arimidex or Femara yet, but will be starting .
Exclusion Criteria:
- History of metastasis
- History of chronic kidney
- Liver GI disease
- Disorders affecting calcium metabolism
Contacts and Locations| United States, Connecticut | |
| University of Connecticut HEalth Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Pamela Taxel, MD | University of Connecticut Health Center |
More Information
No publications provided
| Responsible Party: | Pamela Taxel, Associate Professor of Medicine, University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00762294 History of Changes |
| Other Study ID Numbers: | 07-043-2, GCRC # 644 |
| Study First Received: | September 26, 2008 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Connecticut Health Center:
|
breast cancer arimidex femara bone health |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Anastrozole |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 16, 2013