Clinical trial NCT00049829: HORIZON-PFT: Pivotal Fracture Trial
Official title: HORIZON-PFT: Pivotal Fracture Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Bisphosphonate,BMD,Height loss, Hip protectors,HRT,
Osteoporosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-11-15
Enrollment: 7700
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of hip fxs
measure: Incidence of new vertebral fxs
Secondary outcomes:
measure: Percent change in hip BMD
measure: New and/or worsening vertebral fxs
measure: All clinical fxs
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis Research
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Los Angeles
country: United States
facility: Orthopaedic Hospital
state: California
city: Oakland
country: United States
facility: The Foundation for Osteoporosis Research and Education
state: California
city: Sacramento
country: United States
facility: University of California Davis- Gen Med Research
state: California
city: San Diego
country: United States
facility: Osteoporosis Prevention Center
state: California
city: San Diego
country: United States
facility: Radiant Research- San Diego
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc
state: California
city: Lakewood
country: United States
facility: Colorado Center for Bone Research
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Hamden
country: United States
facility: Northeast Clinical Research
state: Connecticut
city: Newark
country: United States
facility: Health Core
state: Delaware
city: Ft. Lauderdale
country: United States
facility: CRA Research
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Stuart
country: United States
facility: Radiant
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Gainesville
country: United States
facility: United Osteoporosis Centers (UOC)
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Center for Clinical Research
state: Illinois
city: Indianapolis
country: United States
facility: School of Medicine
state: Indiana
city: Munster
country: United States
facility: Medical Specialists
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Elizabethtown
country: United States
facility: Center for Arthritis and Osteoporosis
state: Kentucky
city: Bangor
country: United States
facility: Maine Center for Osteoporosis Research and Education
state: Maine
city: Hagerstown
country: United States
facility: Osteoporosis Clinical Trial Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Groups
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Mercerville
country: United States
facility: Arthritis Regional Research Center
state: New Jersey
city: Moorestown
country: United States
facility: Phoenix OB-GYN Associates, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center, Inc
state: New Mexico
city: Endwell
country: United States
facility: Endwell Family Physicians
state: New York
city: Mineola
country: United States
facility: Winthrop U Hospital
state: New York
city: Fargo
country: United States
facility: Internal Medicine Associates
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati Bone Health and Osteoporosis Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Wyomissing
country: United States
facility: Radiant
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit
state: Rhode Island
city: Providence
country: United States
facility: Roger William Medical Center
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Memphis
country: United States
facility: University of Tennessee Health Science
state: Tennessee
city: Memphis
country: United States
facility: West Cancer Clinic
state: Tennessee
city: Midland
country: United States
facility: Diabetes Regional Research Center
state: Texas
city: San Antonio
country: United States
facility: Sam Clinical Research Center
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler -Center for Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research, Inc
state: Virginia
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: VA Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Osteoporosis Research Unit
state: Washington
city: Spokane
country: United States
facility: The Physicians Clinic
state: Washington
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.