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OpenTrials
Completed

NCT Number: NCT00762294

Anastrozole and Letrozole

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Connecticut HEalth Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. bone density

    Time frame: baseline, 6 months, 12 months

Secondary outcomes

  1. bone markers

    Time frame: baseline, 1 month, 3 month, 6 month, 12 month

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Connecticut Breast Health Initiative

Registry information

Official study title

Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2008
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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