Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

April 26, 2012 updated by: Novartis Pharmaceuticals

A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

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

  • Germany
      • Nuernberg, Germany
        • Novartis
  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • The Permanente Medical Group
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Colorado Center for Bone Research
    • Florida
      • Gainsville, Florida, United States, 32605
        • Florida Medical Research Institute
      • Stuart, Florida, United States, 34996
        • Radiant Research
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas School of Medicine/ Division of Endocrinology
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Arthritis Center of Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Osteoporosis Research Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Oregon Osteoporosis Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Wyomissing, Pennsylvania, United States, 19610
        • Radiant Research
    • Washington
      • Seattle, Washington, United States, 98144
        • Puget Sound Osteoporosis Center

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:

  • Post-menopausal women between 45 and 79 years of age
  • Must be osteopenic/osteoporotic
  • Treatment with oral bisphosphonate for at least 1 year

Exclusion Criteria:

  • Any woman of child bearing potential
  • Treatment with other bone active agents

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
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations

Secondary Outcome Measures

Outcome Measure
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire

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

May 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 30, 2004

First Submitted That Met QC Criteria

November 30, 2004

First Posted (Estimate)

December 1, 2004

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

  • CZOL446H2313

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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