HORIZON-PFT: Pivotal Fracture Trial

Overview[ - collapse ][ - ]

Purpose 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.
InterventionDrug: Zoledronic Acid
PhasePhase 3
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT00049829
First ReceivedNovember 14, 2002
Last UpdatedNovember 1, 2011
Last verifiedNovember 2011

Tracking Information[ + expand ][ + ]

First Received DateNovember 14, 2002
Last Updated DateNovember 1, 2011
Start DateJanuary 2002
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measures
  • Incidence of hip fxs
  • Incidence of new vertebral fxs
Current Secondary Outcome Measures
  • Percent change in hip BMD
  • New and/or worsening vertebral fxs
  • All clinical fxs

Descriptive Information[ + expand ][ + ]

Brief TitleHORIZON-PFT: Pivotal Fracture Trial
Official TitleHORIZON-PFT: Pivotal Fracture Trial
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
InterventionDrug: Zoledronic Acid
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment7700
Estimated Completion DateNot Provided
Estimated Primary Completion DateJune 2006
Eligibility Criteria
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.
Ages65 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Germany

Administrative Information[ + expand ][ + ]

NCT Number NCT00049829
Other Study ID NumbersCZOL446H2301
Has Data Monitoring CommitteeNot Provided
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Not Provided
Verification DateNovember 2011

Locations[ + expand ][ + ]

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