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Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

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ClinicalTrials.gov Identifier: NCT00114270
Recruitment Status : Completed
First Posted : June 14, 2005
Last Update Posted : March 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes. Zoledronate may prevent bone loss caused by letrozole. Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss.

PURPOSE: This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density.

Condition or disease Intervention/treatment
Breast Cancer Osteoporosis Drug: letrozole Drug: zoledronic acid

Detailed Description:



  • Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledronate.
  • Compare the percent change in biochemical markers of bone turnover in participants treated with these regimens.


  • Compare the bone density in participants treated with these regimens.
  • Compare growth hormone release and insulin-like growth factor levels in participants treated with these regimens.
  • Compare the incidence and severity of adverse events in participants treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, pilot study. Participants are stratified according to prior hormone replacement therapy (HRT) use (discontinued HRT > 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Participants receive oral placebo once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months.
  • Arm II: Participants receive oral letrozole once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months.
  • Arm III: Participants receive oral letrozole once daily for 12 months and zoledronate IV over 15 minutes on day 0 and at 6 months.

In all arms, treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, participants are followed at 3 months.

PROJECTED ACCRUAL: A total of 120 participants (40 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women
Study Start Date : May 2004
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • Healthy participant
  • Postmenopausal for > 5 years
  • Breast density ≥ 50% by digitized mammography
  • No history of breast cancer, breast implant, or gynecological malignancy
  • No osteoporosis or postmenopausal fractures

    • T-scores ≥ -2.0 by dual-energy x-ray absorptiometry (DEXA) scan



  • 18 and over


  • Female

Menopausal status

  • See Disease Characteristics

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Not specified


  • AST or ALT ≤ 3 times normal


  • Creatinine ≤ 1.5 mg/dL


  • No cardiac disease


  • Nonsmoker
  • Vitamin D ≥ 15 ng/mL
  • No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance or participation
  • No alcohol consumption of > 2 alcoholic drinks per day
  • No malabsorption


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • At least 1 year since prior hormone replacement therapy
  • No concurrent steroids, parathyroid hormone, or raloxifene


  • Not specified


  • Not specified


  • No other concurrent medication known to affect calcium and bone metabolism (e.g., anticoagulants, antiseizure medications, bisphosphonates, or calcitonin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114270

United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
Principal Investigator: Ailleen Heras-Herzig, MD University of Virginia

ClinicalTrials.gov Identifier: NCT00114270     History of Changes
Other Study ID Numbers: CDR0000430927
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: April 2006

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents