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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hip fxs | ||
| Incidence of new vertebral fxs |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in hip BMD | ||
| New and/or worsening vertebral fxs | ||
| All clinical fxs |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| Arizona Arthritis Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32361951 | Derived | 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. | |
| 25599365 |
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| 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 |
| 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. |
| 25111880 | Derived | 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. |
| 21542001 | Derived | 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. |
| 21037195 | Derived | 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. |
| 19567517 | Derived | 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. |
| 17476007 | Derived | 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. |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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