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Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

NCT00082277 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2011-01-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Conditions

Interventions

DRUG

Anastrozole

1mg/Day Oral

DRUG

Risedronate Sodium

35mg/week, oral

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Arimidex Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States
  • Canada
  • France
  • Greece
  • Netherlands
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT00082277 on ClinicalTrials.gov