Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

April 26, 2012 updated by: Novartis Pharmaceuticals
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

288

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Garvan Institute of Medical Research
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Repatriation General Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Keogh Institute for Medical Research
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2N6
        • Clinical Research Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII HealthSciences Center
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton Medical Building
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Centre de Recherche Clinique de Laval
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Sainte-Foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Rhumatologie et Maladies Osseuses
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Saskatoon Osteoporosis Center
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Catalina Pointe Clinical Research Inc.
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Colorado Center for Bone Research
    • Florida
      • Stuart, Florida, United States, 34996
        • Radiant Research
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • United Osteoporosis Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Center for Clinical Research
    • Iowa
      • Des Moines, Iowa, United States, 50322
        • Mercy Arthritis and Osteoporosis Center
    • Maine
      • Bangor, Maine, United States, 04401
        • St. Joseph Hospital
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Osteoporosis and Clinical Trials Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research and Osteoporosis Center
    • New York
      • West Haverstraw, New York, United States, 10993
        • Helen Hayes Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • UC Bone Health and Osteoporosis Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Radiant Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Hampton Roads Center for Clinical Research
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical 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

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male, 25-85 years old

Exclusion Criteria:

  • Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
  • History of severe liver, kidney or eye disease

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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Secondary Outcome Measures

Outcome Measure
To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

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

  • CZOL446M2308

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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