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

NCT ID: NCT00171314

Last Updated: 2012-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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.

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Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.

Letrozole

Intervention Type DRUG

Letrozole tablets 2.5 mg/day/taken orally for 5 years.

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

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.

Letrozole

Intervention Type DRUG

Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Interventions

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Zoledronic acid

Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.

Intervention Type DRUG

Letrozole

Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Intervention Type DRUG

Other Intervention Names

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ZOL446 Zometa® Femara®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Buenos Aires, , Argentina

Site Status

Novartis Investigative Site

Rosario - Santa Fe, , Argentina

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Novartis Investigative Site

Aalst, , Belgium

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Novartis Investigative Site

Anderlecht, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Libramont-Chevigny, , Belgium

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Liège, , Belgium

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Mons, , Belgium

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Ottignies, , Belgium

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Saint Niklaas, , Belgium

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Wilrijk, , Belgium

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Yvoir, , Belgium

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Limoges, , France

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Mougins, , France

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Périgueux, , France

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Rennes, , France

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Saint-Brieuc, , France

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Saint-Herblain, , France

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Toulon, , France

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Vandœuvre-lès-Nancy, , France

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Genova, , Italy

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Ivrea, , Italy

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Lecco, , Italy

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Monteforte Irpino (Av), , Italy

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Pietra Ligure, , Italy

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Roma, , Italy

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Sassari, , Italy

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Torino, , Italy

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Vicenza, , Italy

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Eindhoven, , Netherlands

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Hoogeveen, , Netherlands

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Nijmegen, , Netherlands

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The Hague, , Netherlands

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Riyadh, , Saudi Arabia

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Novartis Investigative Site

Daegu, , South Korea

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Novartis Investigative Site

Jeollanam-do, , South Korea

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Novartis Investigative Site

Seoul, , South Korea

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Novartis Investigative Site

Barcelona, , Spain

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Novartis Investigative Site

Córdoba, , Spain

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Madrid, , Spain

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Novartis Investigative Site

Valencia, , Spain

Site Status

Countries

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Argentina Belgium France Italy Netherlands Saudi Arabia South Africa South Korea Spain

Other Identifiers

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CFEM345D2406

Identifier Type: -

Identifier Source: org_study_id

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