Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

April 10, 2012 updated by: Novartis Pharmaceuticals

An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy

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)

1065

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
  • Australia
      • New South Wales, Australia
        • Novartis Investigative Site
      • Perth, Australia
        • Novartis Investigative Site
      • South Australia, Australia
        • Novartis Investigative Site
      • Victoria, Australia
        • Novartis Investigative Site
  • Belgium
      • Bonheiden, Belgium
        • Novartis Investigative Site
      • Brasschaat, Belgium
        • Novartis Investigative Site
      • Brussels, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Wilrijk, Belgium
        • Novartis Investigative Site
  • Brazil
      • Porto Alegre, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
  • Chile
      • Santiago, Chile
        • Novartis Investigative Site
  • China
      • Beijing, China
        • Novartis Investigative Site
      • Shanghai, China
        • Novartis Investigative Site
  • Colombia
      • Medellin, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Nemocnice, Czech Republic
        • Novartis Investigative Site
  • Egypt
      • Cairo, Egypt
        • Novartis Investigative Site
  • Finland
      • Pori, Finland
        • Novartis Investigative Site
      • Turku, Finland
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France
        • Novartis Investigative Site
      • Le Havre, France
        • Novartis Investigative Site
      • Montpellier Cedex, France
        • Novartis Investigative Site
      • Poitiers Cedex, France
        • Novartis Investigative Site
      • St. Cloud, France
        • Novartis Investigative Site
  • Germany
      • Augsberg, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Ebersberg, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Halberstadt, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hoyerswerda, Germany
        • Novartis Investigative Site
      • Kassel, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Munich, Germany
        • Novartis Investigative Site
      • Neunkirchen, Germany
        • Novartis Investigative Site
      • Rostock, Germany
        • Novartis Investigative Site
      • Stadthagen, Germany
        • Novartis Investigative Site
      • Stendal, Germany
        • Novartis Investigative Site
      • Trier, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
      • Wiesbaden, Germany
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
  • Italy
      • Ancona, Italy
        • Novartis Investigative Site
      • Aviano, Italy, 33081
        • Novartis Investigative Site
      • Bergamo, Italy
        • Novartis Investigative Site
      • Catanzaro, Italy, 88100
        • Novartis Investigative Site
      • Firenze, Italy, 50139
        • Novartis Investigative Site
      • Genova, Italy
        • Novartis Investigative Site
      • Meldola, Italy
        • Novartis Investigative Site
      • Modena, Italy
        • Novartis Investigative Site
      • Orbassano Torino, Italy
        • Novartis Investigative Site
      • Perugia, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
      • Varese, Italy
        • Novartis Investigative Site
  • Korea, Republic of
      • Gyeonggi, Korea, Republic of
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 110
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 137
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 138
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 139
        • Novartis Investigative Site
  • Mexico
      • Distrito Federal, Mexico
        • Novartis Investigative Site
  • Netherlands
      • Almere, Netherlands
        • Novartis Investigative Site
      • Arnhem, Netherlands
        • Novartis Investigative Site
      • Den Haag, Netherlands
        • Novartis Investigative Site
      • Ede, Netherlands
        • Novartis Investigative Site
      • Eindhoven, Netherlands
        • Novartis Investigative Site
      • Hoogeveen, Netherlands
        • Novartis Investigative Site
      • Leiden, Netherlands
        • Novartis Investigative Site
      • Nijmegen, Netherlands
        • Novartis Investigative Site
      • Utrecht, Netherlands
        • Novartis Investigative Site
  • New Zealand
      • Hamilton, New Zealand
        • Novartis Investigative Site
      • Wellington, New Zealand
        • Novartis Investigative Site
  • Peru
      • Jesus Maria, Peru
        • Novartis Investigative Site
      • La Victoria, Peru
        • Novartis Investigative Site
      • Surquillo, Peru
        • Novartis Investigative Site
  • Philippines
      • Cebu City, Philippines
        • Novartis Investigative Site
      • Quezon City, Philippines
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Cordoba, Spain
        • Novartis Investigative Site
      • Gea, Spain
        • Novartis Investigative Site
      • Ibanez, Spain
        • Novartis Investigative Site
      • La Maso, Spain
        • Novartis Investigative Site
      • Villaroel, Spain
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland
        • Novartis Investigative Site
      • Locarno, Switzerland
        • Novartis Investigative Site
      • Lugano, Switzerland
        • Novartis Investigative Site
  • Taiwan
      • Chang Hwa, Taiwan, 500
        • Novartis Investigative Site
      • Taipei, Taiwan, 100
        • Novartis Investigative Site
      • Taipei, Taiwan, 105
        • Novartis Investigative Site
      • Taipei, Taiwan, 112
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Bangkok, Thailand
        • Novartis Investigative Site
      • Khonkaen, Thailand, 40002
        • Ratchathew
  • United Kingdom
      • Birmingham, United Kingdom
        • Novartis Investigative Site
      • Essex, United Kingdom
        • Novartis Investigative Site
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • New Castle Upon Tyne, United Kingdom
        • Novartis Investigative Site
      • Nottingham, United Kingdom
        • Novartis Investigative Site
      • Plymouth, United Kingdom
        • Novartis Investigative Site
      • Sheffield, United Kingdom
        • Novartis Investigative Site
      • Swansea, United Kingdom
        • Novartis Investigative Site
  • Venezuela
      • Caracas, Venezuela
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage I-IIIa breast cancer
  • Postmenopausal or recently postmenopausal
  • Recent surgery for breast cancer
  • Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
  • No prior treatment with letrozole

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Metastatic disease
  • Invasive bilateral disease
  • Clinical or radiological evidence of existing fracture in spine or hip
  • Prior treatment with IV bisphosphonates in the past 12 months
  • Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
  • Use of Tibolone within 6 months
  • Prior use of parathyroid hormone for more than 1 week
  • Previous or concomitant malignancy
  • Abnormal renal function
  • History of disease effecting bone metabolism

Other protocol-defined 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
Zolendronic 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
Zolendronic 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
Zolendronic 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
Zolendronic 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
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.
Time Frame: Baseline, 12 months
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.
Time Frame: Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.
Time Frame: Baseline, 5 years.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)
Baseline, 5 years.
Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.
Time Frame: Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)
Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.
Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline
Time Frame: Baseline,3 years
At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.
Baseline,3 years

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2003

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 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 16, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345D2405

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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