HORIZON-PFT: Pivotal Fracture Trial
1 other identifier
interventional
7,700
2 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 14, 2002
CompletedFirst Posted
Study publicly available on registry
November 15, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedNovember 2, 2011
November 1, 2011
4.4 years
November 14, 2002
November 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of hip fxs
Incidence of new vertebral fxs
Secondary Outcomes (3)
Percent change in hip BMD
New and/or worsening vertebral fxs
All clinical fxs
Interventions
Eligibility Criteria
You may qualify if:
- Female, 65-89 years old
- No history of severe liver, kidney or eye disease
You may not qualify if:
- Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
- Using hip protectors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Arizona Arthritis Research
Paradise Valley, Arizona, 85253, United States
Southern Arizona VA
Tucson, Arizona, 85723, United States
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205, United States
Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
Orthopaedic Hospital
Los Angeles, California, 90007, United States
The Foundation for Osteoporosis Research and Education
Oakland, California, 94612, United States
University of California Davis- Gen Med Research
Sacramento, California, 95817, United States
Osteoporosis Prevention Center
San Diego, California, 92103, United States
Radiant Research- San Diego
San Diego, California, 92108, United States
Diablo Clinical Research, Inc
Walnut Creek, California, 94598, United States
Colorado Center for Bone Research
Lakewood, Colorado, 80227, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
Northeast Clinical Research
Hamden, Connecticut, 06518-3272, United States
Health Core
Newark, Delaware, 19713-2072, United States
CRA Research
Fort Lauderdale, Florida, 33334, United States
Anchor Research Center
Naples, Florida, 34102, United States
Sarasota Arthritis Center
Sarasota, Florida, 34239, United States
Radiant
Stuart, Florida, 34996, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
United Osteoporosis Centers (UOC)
Gainesville, Georgia, 30501, United States
Northwestern University Center for Clinical Research
Chicago, Illinois, 60611, United States
School of Medicine
Indianapolis, Indiana, 46202, United States
Medical Specialists
Munster, Indiana, 46321, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Maine Center for Osteoporosis Research and Education
Bangor, Maine, 04401, United States
Osteoporosis Clinical Trial Center
Hagerstown, Maryland, 21740, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Clinical Pharmacology Study Groups
Worcester, Massachusetts, 01610, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Arthritis Regional Research Center
Mercerville, New Jersey, 08619, United States
Phoenix OB-GYN Associates, LLC
Moorestown, New Jersey, 08057, United States
New Mexico Clinical Research and Osteoporosis Center, Inc
Albuquerque, New Mexico, 87106, United States
Endwell Family Physicians
Endwell, New York, 13760, United States
Winthrop U Hospital
Mineola, New York, 11501, United States
Internal Medicine Associates
Fargo, North Dakota, 58104, United States
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Einstein
Philadelphia, Pennsylvania, 19115, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19131, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Radiant
Wyomissing, Pennsylvania, 19610, United States
Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
Providence, Rhode Island, 02903, United States
Roger William Medical Center
Providence, Rhode Island, 02908, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
University of Tennessee Health Science
Memphis, Tennessee, 38105, United States
West Cancer Clinic
Memphis, Tennessee, 38120, United States
Diabetes Regional Research Center
Midland, Texas, 79705, United States
Sam Clinical Research Center
San Antonio, Texas, 78229, United States
University of Texas Health Center at Tyler -Center for Clinical Research
Tyler, Texas, 75708, United States
Hampton Roads Center for Clinical Research, Inc
Norfolk, Virginia, 23502, United States
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
VA Commonwealth University
Richmond, Virginia, 23298, United States
Osteoporosis Research Unit
Seattle, Washington, 98144, United States
The Physicians Clinic
Spokane, Washington, 99204, United States
Novartis
Nuremberg, Germany
Related Publications (7)
Cai G, Keen HI, Host LV, Aitken D, Laslett LL, Winzenberg T, Wluka AE, Black D, Jones G. Once-yearly zoledronic acid and change in abdominal aortic calcification over 3 years in postmenopausal women with osteoporosis: results from the HORIZON Pivotal Fracture Trial. Osteoporos Int. 2020 Sep;31(9):1741-1747. doi: 10.1007/s00198-020-05430-z. Epub 2020 May 2.
PMID: 32361951DERIVEDMathew A, Brufsky A. Bisphosphonates do not reduce breast cancer in postmenopausal women. Ann Intern Med. 2015 Jan 20;162(2):JC5. doi: 10.7326/ACPJC-2015-162-2-005. No abstract available.
PMID: 25599365DERIVEDHue TF, Cummings SR, Cauley JA, Bauer DC, Ensrud KE, Barrett-Connor E, Black DM. Effect of bisphosphonate use on risk of postmenopausal breast cancer: results from the randomized clinical trials of alendronate and zoledronic acid. JAMA Intern Med. 2014 Oct;174(10):1550-7. doi: 10.1001/jamainternmed.2014.3634.
PMID: 25111880DERIVEDCauley JA, Black D, Boonen S, Cummings SR, Mesenbrink P, Palermo L, Man Z, Hadji P, Reid IR; HORIZON Pivotal Fracture Group. Once-yearly zoledronic acid and days of disability, bed rest, and back pain: randomized, controlled HORIZON Pivotal Fracture Trial. J Bone Miner Res. 2011 May;26(5):984-92. doi: 10.1002/jbmr.292.
PMID: 21542001DERIVEDGrbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
PMID: 21037195DERIVEDEastell 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. doi: 10.1210/jc.2008-2765. Epub 2009 Jun 30.
PMID: 19567517DERIVEDBlack 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. doi: 10.1056/NEJMoa067312.
PMID: 17476007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2002
First Posted
November 15, 2002
Study Start
January 1, 2002
Primary Completion
June 1, 2006
Last Updated
November 2, 2011
Record last verified: 2011-11