The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

March 19, 2012 updated by: Novartis Pharmaceuticals
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

527

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Rosario - Santa Fe, Argentina
        • Novartis Investigative Site
  • Belgium
      • Aalst, Belgium
        • Novartis Investigative Site
      • Anderlecht, Belgium
        • Novartis Investigative Site
      • Bonheiden, Belgium
        • Novartis Investigative Site
      • Brasschaat, Belgium
        • Novartis Investigative Site
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Edegem, Belgium
        • Novartis Investigative Site
      • Hasselt, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Libramont-Chevigny, Belgium
        • Novartis Investigative Site
      • Liège, Belgium
        • Novartis Investigative Site
      • Mons, Belgium
        • Novartis Investigative Site
      • Ottignies, Belgium
        • Novartis Investigative Site
      • St. Niklaas, Belgium
        • Novartis Investigative Site
      • Wilrijk, Belgium
        • Novartis Investigative Site
      • Yvoir, Belgium
        • Novartis Investigative Site
  • France
      • Limoges, France
        • Novartis Investigative Site
      • Mougins, France
        • Novartis Investigative Site
      • Perigueux Cedex, France
        • Novartis Investigative Site
      • Rennes, France
        • Novartis Investigative Site
      • Saint Brieuc Cedex, France
        • Novartis Investigative Site
      • Saint-Herblain Cedex, France
        • Novartis Investigative Site
      • Toulon Cedex, France
        • Novartis Investigative Site
      • Vandoeuvre Les Nancy Cedex, France
        • Novartis Investigative Site
  • Italy
      • Genova, Italy
        • Novartis Investigative Site
      • Ivrea, Italy
        • Novartis Investigative Site
      • Lecco, Italy
        • Novartis Investigative Site
      • Monteforte Irpino (Av), Italy
        • Novartis Investigative Site
      • Pietra Ligure, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site
      • Sassari, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
      • Vicenza, Italy
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Novartis Investigative Site
      • Jeollanam-do, Korea, Republic of
        • Novartis Investigative Site
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Netherlands
      • Den Haag, Netherlands
        • Novartis Investigative Site
      • Eindhoven, Netherlands
        • Novartis Investigative Site
      • Hoogeveen, Netherlands
        • Novartis Investigative Site
      • Nijmegen, Netherlands
        • Novartis Investigative Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa
        • Novartis Investigative Site
      • Durban, South Africa
        • Novartis Investigative Site
      • Johannesburg, South Africa
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Cordoba, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage I-IIIa breast cancer
  • Postmenopausal
  • Recent surgery for breast cancer

Exclusion Criteria:

  • Metastatic disease
  • Invasive bilateral disease
  • Clinical or radiological evidence of existing fracture in spine or hip

Other protocol-defined inclusion / exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upfront Zoledronic Acid
Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
Drug: Zoledronic acid
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day/taken orally for 5 years.
Other Names:
  • Femara®
Experimental: Delayed Zoledronic Acid
Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
Drug: Zoledronic acid
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
Other Names:
  • ZOL446
  • Zometa®
Drug: Letrozole
Letrozole tablets 2.5 mg/day/taken orally for 5 years.
Other Names:
  • Femara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy
Time Frame: From Baseline - 12 months
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
From Baseline - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years
Time Frame: From Baseline to Year 2, Year 3, Year 4, Year 5
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
From Baseline to Year 2, Year 3, Year 4, Year 5
Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Time Frame: From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5
Time Frame: From baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
From baseline to Year 1, Year 2, Year 3, Year 4, Year 5
Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3
Time Frame: Year 3
Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.
Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345D2406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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