HORIZON-PFT: Pivotal Fracture Trial

NCT ID: NCT00049829

Last Updated: 2011-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zoledronic Acid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Arthritis Research

Paradise Valley, Arizona, United States

Site Status

Southern Arizona VA

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Science

Little Rock, Arkansas, United States

Site Status

Osteoporosis Medical Center

Beverly Hills, California, United States

Site Status

Orthopaedic Hospital

Los Angeles, California, United States

Site Status

The Foundation for Osteoporosis Research and Education

Oakland, California, United States

Site Status

University of California Davis- Gen Med Research

Sacramento, California, United States

Site Status

Osteoporosis Prevention Center

San Diego, California, United States

Site Status

Radiant Research- San Diego

San Diego, California, United States

Site Status

Diablo Clinical Research, Inc

Walnut Creek, California, United States

Site Status

Colorado Center for Bone Research

Lakewood, Colorado, United States

Site Status

Longmont Medical Research Network

Longmont, Colorado, United States

Site Status

Northeast Clinical Research

Hamden, Connecticut, United States

Site Status

Health Core

Newark, Delaware, United States

Site Status

CRA Research

Fort Lauderdale, Florida, United States

Site Status

Anchor Research Center

Naples, Florida, United States

Site Status

Sarasota Arthritis Center

Sarasota, Florida, United States

Site Status

Radiant

Stuart, Florida, United States

Site Status

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

United Osteoporosis Centers (UOC)

Gainesville, Georgia, United States

Site Status

Northwestern University Center for Clinical Research

Chicago, Illinois, United States

Site Status

School of Medicine

Indianapolis, Indiana, United States

Site Status

Medical Specialists

Munster, Indiana, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Center for Arthritis and Osteoporosis

Elizabethtown, Kentucky, United States

Site Status

Maine Center for Osteoporosis Research and Education

Bangor, Maine, United States

Site Status

Osteoporosis Clinical Trial Center

Hagerstown, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Clinical Pharmacology Study Groups

Worcester, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Arthritis Regional Research Center

Mercerville, New Jersey, United States

Site Status

Phoenix OB-GYN Associates, LLC

Moorestown, New Jersey, United States

Site Status

New Mexico Clinical Research and Osteoporosis Center, Inc

Albuquerque, New Mexico, United States

Site Status

Endwell Family Physicians

Endwell, New York, United States

Site Status

Winthrop U Hospital

Mineola, New York, United States

Site Status

Internal Medicine Associates

Fargo, North Dakota, United States

Site Status

University of Cincinnati Bone Health and Osteoporosis Center

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Einstein

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Radiant

Wyomissing, Pennsylvania, United States

Site Status

Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit

Providence, Rhode Island, United States

Site Status

Roger William Medical Center

Providence, Rhode Island, United States

Site Status

Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

University of Tennessee Health Science

Memphis, Tennessee, United States

Site Status

West Cancer Clinic

Memphis, Tennessee, United States

Site Status

Diabetes Regional Research Center

Midland, Texas, United States

Site Status

Sam Clinical Research Center

San Antonio, Texas, United States

Site Status

University of Texas Health Center at Tyler -Center for Clinical Research

Tyler, Texas, United States

Site Status

Hampton Roads Center for Clinical Research, Inc

Norfolk, Virginia, United States

Site Status

McGuire Veterans Affairs Medical Center

Richmond, Virginia, United States

Site Status

VA Commonwealth University

Richmond, Virginia, United States

Site Status

Osteoporosis Research Unit

Seattle, Washington, United States

Site Status

The Physicians Clinic

Spokane, Washington, United States

Site Status

Novartis

Nuremberg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32361951 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25599365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25111880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21542001 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21037195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19567517 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17476007 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CZOL446H2301

Identifier Type: -

Identifier Source: org_study_id