Anastrozole and Letrozole

This study has been completed.
Sponsor:
Collaborator:
Connecticut Breast Health Initiative
Information provided by (Responsible Party):
Pamela Taxel, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00762294
First received: September 26, 2008
Last updated: December 14, 2011
Last verified: December 2011

September 26, 2008
December 14, 2011
May 2007
December 2011   (final data collection date for primary outcome measure)
bone density [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00762294 on ClinicalTrials.gov Archive Site
bone markers [ Time Frame: baseline, 1 month, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anastrozole and Letrozole
Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women receiving treatment for breast cancer, who will be starting Arimidex or Femara

Breast Cancer
Not Provided
644-001
Women treated for breast cancer who will be starting Arimidex or Femara
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00762294
07-043-2, GCRC # 644
No
Pamela Taxel, University of Connecticut Health Center
University of Connecticut Health Center
Connecticut Breast Health Initiative
Principal Investigator: Pamela Taxel, MD University of Connecticut Health Center
University of Connecticut Health Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP