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OsteoporosisPhase 3NCT00049829

HORIZON-PFT: Pivotal Fracture Trial

A Phase 3 study testing Zoledronic Acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 60 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 89 years, women only
Conditions the study is for
Osteoporosis
What is being tested?
Zoledronic Acid
How many people
7,700 participants
Where
60 sitesin 2 countries
Study dates
Jan 2002to Jun 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 89 years
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Female, 65-89 years old
  • No history of severe liver, kidney or eye disease

Who cannot join

  • 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.

Trial locations and contacts

60 sites in 2 countries.

60 sites in 2 countries

United States59 sites

  • New Mexico Clinical Research and Osteoporosis Center, Inc

    Albuquerque, New Mexico, 87106

  • Maine Center for Osteoporosis Research and Education

    Bangor, Maine, 04401

  • Osteoporosis Medical Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Northwestern University Center for Clinical Research

    Chicago, Illinois, 60611

  • University of Cincinnati Bone Health and Osteoporosis Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center for Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Endwell Family Physicians

    Endwell, New York, 13760

  • Internal Medicine Associates

    Fargo, North Dakota, 58104

  • CRA Research

    Fort Lauderdale, Florida, 33334

  • United Osteoporosis Centers (UOC)

    Gainesville, Georgia, 30501

  • Osteoporosis Clinical Trial Center

    Hagerstown, Maryland, 21740

  • Northeast Clinical Research

    Hamden, Connecticut, 06518-3272

  • School of Medicine

    Indianapolis, Indiana, 46202

  • Colorado Center for Bone Research

    Lakewood, Colorado, 80227

  • University of Arkansas for Medical Science

    Little Rock, Arkansas, 72205

  • Longmont Medical Research Network

    Longmont, Colorado, 80501

  • Orthopaedic Hospital

    Los Angeles, California, 90007

  • University of Tennessee Health Science

    Memphis, Tennessee, 38105

  • West Cancer Clinic

    Memphis, Tennessee, 38120

  • Arthritis Regional Research Center

    Mercerville, New Jersey, 08619

  • Diabetes Regional Research Center

    Midland, Texas, 79705

  • Winthrop U Hospital

    Mineola, New York, 11501

  • Phoenix OB-GYN Associates, LLC

    Moorestown, New Jersey, 08057

  • Medical Specialists

    Munster, Indiana, 46321

  • Anchor Research Center

    Naples, Florida, 34102

  • Health Core

    Newark, Delaware, 19713-2072

  • Hampton Roads Center for Clinical Research, Inc

    Norfolk, Virginia, 23502

  • The Foundation for Osteoporosis Research and Education

    Oakland, California, 94612

  • Arizona Arthritis Research

    Paradise Valley, Arizona, 85253

  • Einstein

    Philadelphia, Pennsylvania, 19115

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19131

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Oregon Health and Science University

    Portland, Oregon, 97201

  • Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit

    Providence, Rhode Island, 02903

  • Roger William Medical Center

    Providence, Rhode Island, 02908

  • McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • VA Commonwealth University

    Richmond, Virginia, 23298

  • University of California Davis- Gen Med Research

    Sacramento, California, 95817

  • Sam Clinical Research Center

    San Antonio, Texas, 78229

  • Osteoporosis Prevention Center

    San Diego, California, 92103

  • Radiant Research- San Diego

    San Diego, California, 92108

  • Sarasota Arthritis Center

    Sarasota, Florida, 34239

  • Osteoporosis Research Unit

    Seattle, Washington, 98144

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • The Physicians Clinic

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Radiant

    Stuart, Florida, 34996

  • Southern Arizona VA

    Tucson, Arizona, 85723

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

    Tyler, Texas, 75708

  • Diablo Clinical Research, Inc

    Walnut Creek, California, 94598

  • Comprehensive Clinical Trials, LLC

    West Palm Beach, Florida, 33409

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Clinical Pharmacology Study Groups

    Worcester, Massachusetts, 01610

  • Radiant

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany1 site

  • Novartis

    Nuremberg

Other trials in Germany

About this study

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.

Conditions
Osteoporosis
Being tested
Zoledronic Acid
Keywords
Bisphosphonate,BMD,Height loss, Hip protectors,HRT,, Osteoporosis
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hip fxs

  2. Incidence of new vertebral fxs

Secondary outcomes (3)

  1. Percent change in hip BMD

  2. New and/or worsening vertebral fxs

  3. All clinical fxs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2002 (estimated)
  2. Study startJan 2002
  3. Primary completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
7,700 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049829
Sponsor's protocol ID
CZOL446H2301
Status last verified
Nov 2011
First submitted
14 Nov 2002
Last updated
2 Nov 2011
Results posted
No

Publications

  • 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.

    PubMed 32361951

  • 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.

    PubMed 25599365

  • 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.

    PubMed 25111880

  • 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.

    PubMed 21542001

  • 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.

    PubMed 21037195

  • 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.

    PubMed 19567517

  • 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.

    PubMed 17476007

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zoledronic Acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 60 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hip fxs. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049829, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.

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