Clinical trial · Interventional
Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer
NCT00049452CI-TRIAL-00013313completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Changes in lumbar spine bone mineral density (BMD) at 6 months
Secondary outcomes (5)
- measure
- Changes in lumbar spine BMD at 12 and 24 months
- measure
- Total hip and femoral neck BMD at 6, 12, and 24 months
- measure
- Serum markers of bone turnover (osteocalcin, bone-specific alkaline phosphatase, and cross-linked C-telopeptide of type 1 collagen levels) measured every 6 weeks for 6 months, and at 9 and 12 months
- measure
- Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months
- measure
- Treatment costs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of localized breast cancer * Stage I or II (T1-3, N0-2, M0) * Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration * Hormone receptor status: * Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age * 18 to 50 Sex * Female Menopausal status * Premenopausal or perimenopausal Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine less than 2 mg/dL Other * No T score of less than 2.0 on bone mineral density (BMD) * No fragility fracture * No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * At least 1 month since prior calcitonin * At least 12 months since prior bisphosphonates given for more than 1 month duration * No concurrent fluoride therapy (10 mg/day or more) * No concurrent enrollment in another experimental drug study
References
Publications (3)
- RESULTHershman DL, McMahon DJ, Crew KD, Shao T, Cremers S, Brafman L, Awad D, Shane E. Prevention of bone loss by zoledronic acid in premenopausal women undergoing adjuvant chemotherapy persist up to one year following discontinuing treatment. J Clin Endocrinol Metab. 2010 Feb;95(2):559-66. doi: 10.1210/jc.2009-1366. Epub 2009 Dec 18. PMID 20022990
- RESULTHershman DL, McMahon DJ, Crew KD, Cremers S, Irani D, Cucchiara G, Brafman L, Shane E. Zoledronic acid prevents bone loss in premenopausal women undergoing adjuvant chemotherapy for early-stage breast cancer. J Clin Oncol. 2008 Oct 10;26(29):4739-45. doi: 10.1200/JCO.2008.16.4707. Epub 2008 Aug 18. PMID 18711172
- 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