HORIZON-PFT: Pivotal Fracture Trial

November 1, 2011 updated by: Novartis Pharmaceuticals
HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

7700

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis Research
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Science
    • California
      • Beverly Hills, California, United States, 90211
        • Osteoporosis Medical Center
      • Los Angeles, California, United States, 90007
        • Orthopaedic hospital
      • Oakland, California, United States, 94612
        • The Foundation for Osteoporosis Research and Education
      • Sacramento, California, United States, 95817
        • University of California Davis- Gen Med Research
      • San Diego, California, United States, 92103
        • Osteoporosis Prevention Center
      • San Diego, California, United States, 92108
        • Radiant Research- San Diego
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc
    • Colorado
      • Lakewood, Colorado, United States, 80227
        • Colorado Center for Bone Research
      • Longmont, Colorado, United States, 80501
        • Longmont Medical Research Network
    • Connecticut
      • Hamden, Connecticut, United States, 06518-3272
        • Northeast Clinical Research
    • Delaware
      • Newark, Delaware, United States, 19713-2072
        • Health Core
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • CRA Research
      • Naples, Florida, United States, 34102
        • Anchor Research Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center
      • Stuart, Florida, United States, 34996
        • Radiant
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • United Osteoporosis Centers (UOC)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Center for Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • School Of Medicine
      • Munster, Indiana, United States, 46321
        • Medical Specialists
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center for Arthritis and Osteoporosis
    • Maine
      • Bangor, Maine, United States, 04401
        • Maine Center for Osteoporosis Research and Education
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Osteoporosis Clinical Trial Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Groups
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Mercerville, New Jersey, United States, 08619
        • Arthritis Regional Research Center
      • Moorestown, New Jersey, United States, 08057
        • Phoenix OB-GYN Associates, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research and Osteoporosis Center, Inc
    • New York
      • Endwell, New York, United States, 13760
        • Endwell Family Physicians
      • Mineola, New York, United States, 11501
        • Winthrop U Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Internal Medicine Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Bone Health and Osteoporosis Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health and Science University
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19131
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19115
        • Einstein
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh
      • Wyomissing, Pennsylvania, United States, 19610
        • Radiant
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
      • Providence, Rhode Island, United States, 02908
        • Roger William Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • University of Tennessee Health Science
      • Memphis, Tennessee, United States, 38120
        • West Cancer Clinic
    • Texas
      • Midland, Texas, United States, 79705
        • Diabetes Regional Research Center
      • San Antonio, Texas, United States, 78229
        • SAM Clinical Research Center
      • Tyler, Texas, United States, 75708
        • University of Texas Health Center at Tyler -Center for Clinical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Hampton Roads Center for Clinical Research, Inc
      • Richmond, Virginia, United States, 23249
        • McGuire Veterans Affairs Medical Center
      • Richmond, Virginia, United States, 23298
        • VA Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98144
        • Osteoporosis Research Unit
      • Spokane, Washington, United States, 99204
        • The Physicians Clinic

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

65 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, 65-89 years old
  • No history of severe liver, kidney or eye disease

Exclusion Criteria:

  • Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
  • Using hip protectors

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
Incidence of hip fxs
Incidence of new vertebral fxs

Secondary Outcome Measures

Outcome Measure
Percent change in hip BMD
New and/or worsening vertebral fxs
All clinical fxs

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

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

January 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 14, 2002

First Submitted That Met QC Criteria

November 14, 2002

First Posted (Estimate)

November 15, 2002

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446H2301

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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