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

NCT00114270 | Completed

• 3 other identifiers: CDR0000430927UVACC-HIC-11019UVACC-31003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Osteoporosis

Keywords

breast cancer; osteoporosis

Interventions

letrozole DRUG

zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * See Disease Characteristics Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * AST or ALT ≤ 3 times normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No cardiac disease Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 1 year since prior hormone replacement therapy * No concurrent steroids, parathyroid hormone, or raloxifene Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent medication known to affect calcium and bone metabolism (e.g., anticoagulants, antiseizure medications, bisphosphonates, or calcitonin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Letrozole; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Imidazoles

Study Officials

• Ailleen Heras-Herzig, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2005
• First Posted: June 14, 2005
• Study Start: May 1, 2004
• Study Completion: June 1, 2007
• Last Updated: March 26, 2013

Record last verified: 2006-04

Locations

US (1)