Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer; Osteoporosis

• Registration Number: NCT00049452
• Lead Sponsor: Herbert Irving Comprehensive Cancer Center

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.

Detailed Description

OBJECTIVES:

* Compare the changes in bone mineral density (BMD) and bone turnover that occur in premenopausal women with resected early stage breast cancer during and after 6 months of adjuvant chemotherapy.

* Determine the factors that predict bone loss during chemotherapy, particularly induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline BMD, in these patients.

* Determine whether zoledronate prevents bone loss in these patients when given during and after adjuvant chemotherapy.

* Determine the effect of zoledronate on markers of bone turnover in these patients during and after adjuvant chemotherapy.

* Determine whether the effect on markers of bone turnover predicts response to zoledronate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative), progesterone receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive zoledronate IV over 15 minutes on day 1.

* Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment repeats every 3 months for up to 4 courses in the absence of disease progression. Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.

Quality of life is assessed at baseline and at 6 and 12 months.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-11-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-04
• Study Completion: 2008-08
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in lumbar spine bone mineral density (BMD) at 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Carl and Dorothy Bennett Cancer Center at Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States

Herbert Irving Comprehensive Cancer Center at Columbia University; 🇺🇸 New York, New York, United States

Valley Hospital - Paramus; 🇺🇸 Paramus, New Jersey, United States