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HORIZON-PFT: Pivotal Fracture Trial



HORIZON-PFT: Pivotal Fracture Trial

For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: 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.
Details: The HORIZON-PFT study is currently underway in more than 200 centers in the United States, Canada, Europe, Asia Pacific and South America. It is our goal to recruit 7400 women with osteoporosis for this study. All study medications are provided to you free of charge including calcium and vitamin D supplements.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 65 Years/89 Years
Genders: Female
Protocol Entry 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® (residronate), Skelid® (tiludronate) - Using hip protectors
Total Enrollment: 7400

Location and Contact Information:

McGuire Veterans Affairs Medical Center
Richmond,  Virginia,  23249
United States
 

VA Commonwealth University
Richmond,  Virginia,  23298
United States
 

University of Texas Health Center at Tyler -Center for Clinical Research
Tyler,  Texas,  75708
United States
 

Longmont Medical Research Network
Longmont,  Colorado,  80501
United States
 

Radiant
Wyomissing,  Pennsylvania,  19610
United States
 

Northwestern University Center for Clinical Research
Chicago,  Illinois,  60611
United States
 

University of Pittsburgh
Pittsburgh,  Pennsylvania,  15261
United States
 

Radiant Research- San Diego
San Diego,  California,  92108
United States
 

United Osteoporosis Centers (UOC)
Gainesville,  Georgia,  30501
United States
 

Health Core
Newark,  Delaware,  19713-2072
United States
 

Winthrop U Hospital
Mineola,  New York,  11501
United States
 

Anchor Research Center
Naples,  Florida,  34102
United States
 

Internal Medicine Associates
Fargo,  North Dakota,  58104
United States
 

Sarasota Arthritis Center
Sarasota,  Florida,  34239
United States
 

Einstein
Philadelphia,  Pennsylvania,  19115
United States
 

Heartland Research Associates, LLC
Wichita,  Kansas,  67207
United States
 

Sam Clinical Research Center
San Antonio,  Texas,  78229
United States
 

Thomas Jefferson University Hospital
Philadelphia,  Pennsylvania,  19131
United States
 

New Mexico Clinical Research and Osteoporosis Center, Inc
Albuquerque,  New Mexico,  87106
United States
 

University of Alabama at Birmingham
Birmingham,  Alabama,  35205
United States
 

Washington University School of Medicine
St. Louis,  Missouri,  63110
United States
 

Osteoporosis Medical Center
Beverly Hills,  California,  90211
United States
 

Palm Beach Research Center
West Palm Beach,  Florida,  33409
United States
 

Medical Specialists
Munster,  Indiana,  46321
United States
 

Diabetes Regional Research Center
Midland,  Texas,  79705
United States
 

Colorado Center for Bone Research
Lakewood,  Colorado,  80227
United States
 

Orthopaedic Hospital
Los Angeles,  California,  90007
United States
 

Radiant
Stuart,  Florida,  34996
United States
 

Brigham and Women's Hospital
Boston,  Massachusetts,  02115
United States
 

University of California Davis- Gen Med Research
Sacramento,  California,  95817
United States
 

The Foundation for Osteoporosis Research and Education
Oakland,  California,  94612
United States
 

The Physicians Clinic
Spokane,  Washington,  99204
United States
 

Oregon Health and Science University
Portland,  Oregon,  97201
United States
 

Mount Sinai School of Medicine
New York City,  New York,  10029
United States
 

University of Arkansas for Medical Science
Little Rock,  Arkansas,  72205
United States
 

University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati,  Ohio,  45219
United States
 

Clinical Pharmacology Study Groups
Worcester,  Massachusetts,  01610
United States
 

Altoona Center for Clinical Research
Duncansville,  Pennsylvania,  16635
United States
 

Center for Arthritis and Osteoporosis
Elizabethtown,  Kentucky,  42701
United States
 

Cleveland Clinic Foundation
Cleveland,  Ohio,  44195
United States
 

Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
Providence,  Rhode Island,  02903
United States
 

Osteoporosis Prevention Center
San Diego,  California,  92103
United States
 

Roger William Medical Center
Providence,  Rhode Island,  02908
United States
 

Southern Arizona VA
Tucson,  Arizona,  85723
United States
 

School of Medicine
Indianapolis,  Indiana,  46202
United States
 

Osteoporosis Clinical Trial Center
Hagerstown,  Maryland,  21740
United States
 

Hampton Roads Center for Clinical Research, Inc
Norfolk,  Virginia,  23502
United States
 

Maine Center for Osteoporosis Research and Education
Bangor,  Maine,  04401
United States
 

Avera Research Institute
Sioux Falls,  South Dakota,  57105
United States
 

Endwell Family Physicians
Endwell,  New York,  13760
United States
 

Osteoporosis Research Unit
Seattle,  Washington,  98144
United States
 

Arthritis Regional Research Center
Mercerville,  New Jersey,  08619
United States
 

Northeast Clinical Research
Hamden,  Connecticut,  06518-3272
United States
 

Phoenix OB-GYN Associates, LLC
Moorestown,  New Jersey,  08057
United States
 

Diablo Clinical Research, Inc
Walnut Creek,  California,  94598
United States
 

CRA Research
Ft. Lauderdale,  Florida,  33334
United States
 

West Cancer Clinic
Memphis,  Tennessee,  38120
United States
 

University of Tennessee Health Science
Memphis,  Tennessee,  38105
United States
 

Arizona Arthritis Research
Paradise Valley,  Arizona,  85253
United States
 

Comprehensive Clinical Trials, LLC
West Palm Beach,  Florida,  33409
United States
 


Additional Information:
Study ID Numbers:
  CZOL446H2301; 
Study Start Date: 
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049829

Other Osteoporosis Studies:
1. Treatment of Childhood Osteoporosis with Alendronate (Fosamax)

2. CVD Risk and Health in Postmenopausal Phytoestrogen Users

3. Bone Estrogen Strength Training

4. Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

5. Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

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HORIZON-PFT: Pivotal Fracture Trial

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