Clinical trial · Interventional
Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density
Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available