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HORIZON-PFT: Pivotal Fracture Trial

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Bisphosphonate,BMD,Height loss, Hip protectors,HRT,, Osteoporosis

Eligibility Criteria

65 Years - 89 Years (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Arthritis Research
  • Southern Arizona VA
  • University of Arkansas for Medical Science
  • Osteoporosis Medical Center
  • Orthopaedic Hospital
  • The Foundation for Osteoporosis Research and Education
  • University of California Davis- Gen Med Research
  • Osteoporosis Prevention Center
  • Radiant Research- San Diego
  • Diablo Clinical Research, Inc
  • Colorado Center for Bone Research
  • Longmont Medical Research Network
  • Northeast Clinical Research
  • Health Core
  • CRA Research
  • Anchor Research Center
  • Sarasota Arthritis Center
  • Radiant
  • Comprehensive Clinical Trials, LLC
  • Palm Beach Research Center
  • United Osteoporosis Centers (UOC)
  • Northwestern University Center for Clinical Research
  • School of Medicine
  • Medical Specialists
  • Heartland Research Associates, LLC
  • Center for Arthritis and Osteoporosis
  • Maine Center for Osteoporosis Research and Education
  • Osteoporosis Clinical Trial Center
  • Brigham and Women's Hospital
  • Clinical Pharmacology Study Groups
  • Washington University School of Medicine
  • Arthritis Regional Research Center
  • Phoenix OB-GYN Associates, LLC
  • New Mexico Clinical Research and Osteoporosis Center, Inc
  • Endwell Family Physicians
  • Winthrop U Hospital
  • Internal Medicine Associates
  • University of Cincinnati Bone Health and Osteoporosis Center
  • Cleveland Clinic Foundation
  • Oregon Health and Science University
  • Altoona Center for Clinical Research
  • Einstein
  • Thomas Jefferson University Hospital
  • University of Pittsburgh
  • Radiant
  • Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
  • Roger William Medical Center
  • Avera Research Institute
  • University of Tennessee Health Science
  • West Cancer Clinic
  • Diabetes Regional Research Center
  • Sam Clinical Research Center
  • University of Texas Health Center at Tyler -Center for Clinical Research
  • Hampton Roads Center for Clinical Research, Inc
  • McGuire Veterans Affairs Medical Center
  • VA Commonwealth University
  • Osteoporosis Research Unit
  • The Physicians Clinic
  • Novartis

Outcomes

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

Full Information

First Posted
November 14, 2002
Last Updated
November 1, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00049829
Brief Title
HORIZON-PFT: Pivotal Fracture Trial
Official Title
HORIZON-PFT: Pivotal Fracture Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bisphosphonate,BMD,Height loss, Hip protectors,HRT,, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
7700 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
Incidence of hip fxs
Title
Incidence of new vertebral fxs
Secondary Outcome Measure Information:
Title
Percent change in hip BMD
Title
New and/or worsening vertebral fxs
Title
All clinical fxs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Arizona Arthritis Research
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Southern Arizona VA
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University of Arkansas for Medical Science
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Osteoporosis Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Orthopaedic Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
The Foundation for Osteoporosis Research and Education
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
University of California Davis- Gen Med Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Osteoporosis Prevention Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Radiant Research- San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Diablo Clinical Research, Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Center for Bone Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Northeast Clinical Research
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518-3272
Country
United States
Facility Name
Health Core
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713-2072
Country
United States
Facility Name
CRA Research
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Sarasota Arthritis Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Radiant
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
United Osteoporosis Centers (UOC)
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern University Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Medical Specialists
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Center for Arthritis and Osteoporosis
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Maine Center for Osteoporosis Research and Education
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Osteoporosis Clinical Trial Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clinical Pharmacology Study Groups
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Arthritis Regional Research Center
City
Mercerville
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
Phoenix OB-GYN Associates, LLC
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
New Mexico Clinical Research and Osteoporosis Center, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Endwell Family Physicians
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Winthrop U Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Internal Medicine Associates
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
University of Cincinnati Bone Health and Osteoporosis Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Einstein
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Radiant
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Roger William Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Tennessee Health Science
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
West Cancer Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Diabetes Regional Research Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79705
Country
United States
Facility Name
Sam Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Center at Tyler -Center for Clinical Research
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Hampton Roads Center for Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
VA Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Osteoporosis Research Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
The Physicians Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Novartis
City
Nuernberg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32361951
Citation
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.
Results Reference
derived
PubMed Identifier
25599365
Citation
Mathew 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.
Results Reference
derived
PubMed Identifier
25111880
Citation
Hue 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. Erratum In: JAMA Intern Med. 2014 Nov;174(11):1875.
Results Reference
derived
PubMed Identifier
21542001
Citation
Cauley 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.
Results Reference
derived
PubMed Identifier
21037195
Citation
Grbic 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.
Results Reference
derived
PubMed Identifier
19567517
Citation
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. doi: 10.1210/jc.2008-2765. Epub 2009 Jun 30.
Results Reference
derived
PubMed Identifier
17476007
Citation
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. doi: 10.1056/NEJMoa067312.
Results Reference
derived

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HORIZON-PFT: Pivotal Fracture Trial

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