Clinical trial · Interventional
Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
- 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: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss. PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium salts | Dietary Supplement | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zoledronic acid initial tx
- description
- Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
- interventionNames
- Dietary Supplement: calcium salts
- Dietary Supplement: cholecalciferol
- Drug: zoledronic acid
- type
- EXPERIMENTAL
- label
- Calcium + Vit D initial Tx
- description
- Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
- interventionNames
- Dietary Supplement: calcium salts
- Dietary Supplement: cholecalciferol
- Drug: zoledronic acid
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy (tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy * Stage I-III (any T, any N, M0) * Stage IV due solely to supraclavicular node involvement allowed * Plan to use adjuvant chemotherapy\* with or without adjuvant endocrine therapy\* * Subsequent adjuvant hormonal therapy with an aromatase inhibitor allowed in women rendered postmenopausal by adjuvant chemotherapy NOTE: \*Must be specified prior to study entry * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 40 and over Sex: * Female Menopausal status: * See Disease Characteristics * Premenopausal, defined as actively menstruating or last menstrual period occurred within 6 months prior to study entry * Prior hysterectomy without bilateral oophorectomy and estradiol and follicle-stimulating hormone within premenopausal range prior to the initiation of chemotherapy allowed Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 3 months since prior adjuvant chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * Not specified Surgery: * See Disease Characteristics * See Menopausal status Other: * No other concurrent bisphosphonates * No concurrent digoxin * No concurrent tetracycline * Concurrent neoadjuvant therapy allowed * Concurrent enrollment on therapeutic adjuvant clinical trials allowed provided the therapeutic trial does not preclude participation in this trial
References
Publications (2)
- RESULTShapiro CL, Halabi S, Gibson G, et al.: Effect of zoledronic acid (ZA) on bone mineral density (BMD) in premenopausal women who develop ovarian failure (OF) due to adjuvant chemotherapy (AdC): first results from CALGB trial 79809. [Abstract] J Clin Oncol 26 (Suppl 15): A-512, 2008.
- DERIVEDAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. PMID 38979716