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
  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

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • bone density [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762294

Locations
United States, Connecticut
University of Connecticut HEalth Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Connecticut Breast Health Initiative
Investigators
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 July 31, 2014