A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

April 26, 2012 updated by: Novartis Pharmaceuticals
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ. of Alabama/Division of Clinical Immunology and Rheumatology
    • California
      • San DIego, California, United States, 92108
        • Radiant Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Florida
      • Gainesville, Florida, United States, 32605
        • Florida Medical Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Center for Clinical Research
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center For Rheumatology And Bone Research
    • Michigan
      • Kalamazoo, Michigan, United States, 49048-1634
        • Midwest Arthritis Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinic Research Division
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ-Robert Wood Johnson Medical School
    • New York
      • West Haverstraw, New York, United States, 10993
        • Helen Hayes Hospital - Regional Bone Clinic
    • Ohio
      • Mayfield Village, Ohio, United States, 44143
        • Private practice
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Arthritis Clinic of Jackson
    • Texas
      • Dallas, Texas, United States, 75235
        • Radiant Research
      • Fort Worth, Texas, United States, 76107
        • Univ. of North Texas Health Science Center at Fort Worth
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Women's Health Center
    • West Virginia
      • Lewisburg, West Virginia, United States, 24901
        • Valley Medical Associates

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

45 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women between 45 and 79 years of age
  • Must be osteopenic/osteoporotic

Exclusion Criteria:

  • Any women of child-bearing potential

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women

Secondary Outcome Measures

Outcome Measure
To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy

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

June 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

January 3, 2005

First Submitted That Met QC Criteria

January 3, 2005

First Posted (Estimate)

January 4, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446H2315

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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