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

NCT00171340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1065

Last updated 2012-04-16

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Zoledronic acid

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

DRUG

Letrozole

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Chile
  • China
  • Colombia
  • Czechia
  • Egypt
  • Finland
  • France
  • Germany
  • Guatemala
  • Hong Kong
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Philippines
  • Portugal
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom
  • Venezuela

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00171340 on ClinicalTrials.gov