Anastrozole and Letrozole

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762294
• Other study ID #: 07-043-2
• Secondary ID: GCRC # 644
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: December 14, 2011
• Start date: May 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Connecticut HEalth Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	Connecticut Breast Health Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone density		baseline, 6 months, 12 months	Yes
Secondary	bone markers		baseline, 1 month, 3 month, 6 month, 12 month	No