NCT00049452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Dec 2001

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 6, 2014

Status Verified

April 1, 2007

First QC Date

November 12, 2002

Last Update Submit

January 3, 2014

Conditions

Breast CancerOsteoporosis

Keywords

osteoporosisstage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in lumbar spine bone mineral density (BMD) at 6 months

Secondary Outcomes (5)

  • Changes in lumbar spine BMD at 12 and 24 months

  • Total hip and femoral neck BMD at 6, 12, and 24 months

  • 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

  • Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months

  • Treatment costs

Interventions

zoledronic acidDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

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

Sponsors & Collaborators

Study Sites (3)

Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

Valley Hospital - Paramus

Paramus, New Jersey, 07652-2509, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (3)

  • Hershman 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: 20022990RESULT

  • Hershman 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: 18711172RESULT

  • Adams 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: 38979716DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dawn Hershman, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Study Completion

August 1, 2008

Last Updated

January 6, 2014

Record last verified: 2007-04

Locations

US(3)