An open-label, randomized, multicenter study to evaluate the use of Zoledronic Acid in the prevention of cancer treatment-related bone loss in postmenopausal women with ER+ and/or PgR+ breast cancer receiving Letrozole as adjuvant therapy - ZoFast2406

• Conditions: Prevention of cancer treatment-related bone loss in postmenopausal women with ER+ and/or PgR+ breast cancer receiving Letrozole as adjuvant therapy

• Registration Number: EUCTR2004-001369-17-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-16
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Postmenopausal status
Hormone receptor positive ER and/or PgR
Patiens with a baseline lumbar spine and total hip BMD T-score at or above -2.0 SD
Patients with invasive breast cancer
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with invasive bilateral breast cancer
Patients with any clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip
Patients who have received prior treatment with intravenous bisphosphonates within the past 12 months.
Patients with abnormal renal funtion
History of diseases with influence on bone metabolism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the percent in the lumbar spine (L2 to L4) BMD, as measured by dual energy X-ray absorptiometry(DXA), at 12 months in recently postmenopausal and postmenopausal women with hormone receptor positive breast cancer.;Secondary Objective: To describe the percent change in lumbar spine (L2 to L4) BMD at 2 years, 3 years, 4 years and 5 years in the two treatment arms.;Primary end point(s): The primary enpoint is the percent change in the lumbar spine (L2 to L4) regards baseline evaluation