HORIZON-PFT: Pivotal Fracture Trial
- Conditions
- Osteoporosis
- Registration Number
- NCT00049829
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7700
- Female, 65-89 years old
- No history of severe liver, kidney or eye disease
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of hip fxs Incidence of new vertebral fxs
- Secondary Outcome Measures
Name Time Method Percent change in hip BMD New and/or worsening vertebral fxs All clinical fxs
Trial Locations
- Locations (59)
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Maine Center for Osteoporosis Research and Education
🇺🇸Bangor, Maine, United States
Novartis
🇩🇪Nuernberg, Germany
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Northeast Clinical Research
🇺🇸Hamden, Connecticut, United States
Health Core
🇺🇸Newark, Delaware, United States
Radiant Research- San Diego
🇺🇸San Diego, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Osteoporosis Prevention Center
🇺🇸San Diego, California, United States
University of Cincinnati Bone Health and Osteoporosis Center
🇺🇸Cincinnati, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Phoenix OB-GYN Associates, LLC
🇺🇸Moorestown, New Jersey, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Internal Medicine Associates
🇺🇸Fargo, North Dakota, United States
VA Commonwealth University
🇺🇸Richmond, Virginia, United States
Arthritis Regional Research Center
🇺🇸Mercerville, New Jersey, United States
Endwell Family Physicians
🇺🇸Endwell, New York, United States
Einstein
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee Health Science
🇺🇸Memphis, Tennessee, United States
Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
🇺🇸Providence, Rhode Island, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Sam Clinical Research Center
🇺🇸San Antonio, Texas, United States
University of Texas Health Center at Tyler -Center for Clinical Research
🇺🇸Tyler, Texas, United States
The Physicians Clinic
🇺🇸Spokane, Washington, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Hampton Roads Center for Clinical Research, Inc
🇺🇸Norfolk, Virginia, United States
McGuire Veterans Affairs Medical Center
🇺🇸Richmond, Virginia, United States
Osteoporosis Research Unit
🇺🇸Seattle, Washington, United States
Radiant
🇺🇸Wyomissing, Pennsylvania, United States
School of Medicine
🇺🇸Indianapolis, Indiana, United States
Center for Arthritis and Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
United Osteoporosis Centers (UOC)
🇺🇸Gainesville, Georgia, United States
Arizona Arthritis Research
🇺🇸Paradise Valley, Arizona, United States
Southern Arizona VA
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Science
🇺🇸Little Rock, Arkansas, United States
Osteoporosis Medical Center
🇺🇸Beverly Hills, California, United States
Northwestern University Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Orthopaedic Hospital
🇺🇸Los Angeles, California, United States
The Foundation for Osteoporosis Research and Education
🇺🇸Oakland, California, United States
University of California Davis- Gen Med Research
🇺🇸Sacramento, California, United States
Colorado Center for Bone Research
🇺🇸Lakewood, Colorado, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
CRA Research
🇺🇸Ft. Lauderdale, Florida, United States
Anchor Research Center
🇺🇸Naples, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Roger William Medical Center
🇺🇸Providence, Rhode Island, United States
Diablo Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
Medical Specialists
🇺🇸Munster, Indiana, United States
New Mexico Clinical Research and Osteoporosis Center, Inc
🇺🇸Albuquerque, New Mexico, United States
Winthrop U Hospital
🇺🇸Mineola, New York, United States
Clinical Pharmacology Study Groups
🇺🇸Worcester, Massachusetts, United States
West Cancer Clinic
🇺🇸Memphis, Tennessee, United States
Osteoporosis Clinical Trial Center
🇺🇸Hagerstown, Maryland, United States
Diabetes Regional Research Center
🇺🇸Midland, Texas, United States