HORIZON-PFT: Pivotal Fracture Trial - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00049829

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Zoledronic Acid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	HORIZON-PFT: Pivotal Fracture Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of hip fxs
Incidence of new vertebral fxs

Secondary Outcome Measures:

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

Estimated Enrollment:	7700
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	65 Years to 89 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049829

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Locations

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

Sponsors and Collaborators

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Eastell R, Black DM, Boonen S, Adami S, Felsenberg D, Lippuner K, Cummings SR, Delmas PD, Palermo L, Mesenbrink P, Cauley JA; HORIZON Pivotal Fracture Trial. Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density. J Clin Endocrinol Metab. 2009 Sep;94(9):3215-25. Epub 2009 Jun 30.

Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22.

Study ID Numbers:	CZOL446H2301
Study First Received:	November 14, 2002
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00049829 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Bisphosphonate,BMD,Height loss, Hip protectors,HRT,
Osteoporosis

Additional relevant MeSH terms:

Zoledronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009