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The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Significant reduction in rate of clinical fractures after surgical repair of hip fracture |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in total hip and femoral neck BMDs |
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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 Hospital | Birmingham | Alabama | 35294 | United States | ||
| Osteoporosis Diagnostic Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24839241 | Derived | Magaziner JS, Orwig DL, Lyles KW, Nordsletten L, Boonen S, Adachi JD, Recknor C, Colon-Emeric CS, Mesenbrink P, Bucci-Rechtweg C, Su G, Johnson R, Pieper CF. Subgroup variations in bone mineral density response to zoledronic acid after hip fracture. J Bone Miner Res. 2014 Dec;29(12):2545-51. doi: 10.1002/jbmr.2283. | |
| 23812596 | Derived |
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| Eureka |
| California |
| 95503 |
| United States |
| Sharp Grossmont Hosptial | La Mesa | California | 91942 | United States |
| The Permanente Group | Santa Rosa | California | 95403 | United States |
| Radiant Research Lake Worth | Lake Worth | Florida | 33461 | United States |
| Atlanta Resarch Center | Decatur | Georgia | 30033 | United States |
| United Osteoporosis Center Health Services | Gainesville | Georgia | 30501 | United States |
| Galesburg Orthopedic Services LTD | Galesburg | Illinois | 61401 | United States |
| Illinois Bone and Joint Institute | Morton Grove | Illinois | 60053 | United States |
| Mercy Arthritis and Osteoporosis Center | Des Moines | Iowa | 50322 | United States |
| Maine Medical Center Research Institute | Portland | Maine | 04101 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Wayne State University, Div. of Endocrinology | Detroit | Michigan | 48201 | United States |
| Health East Osteoporosis Service | Woodbury | Minnesota | 55125 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| University Orthopaedics | Canfield | Ohio | 44406 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania Health System-Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Saint Joseph Medical Center | West Reading | Pennsylvania | 19611 | United States |
| Saint Josephs | Warwick | Rhode Island | 02818 | United States |
| Palmetto Richland Memorial Hospital | Columbia | South Carolina | 29203 | United States |
| Seton Medical Center | Austin | Texas | 78705 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53706 | United States |
| Novartis | Nuremberg | Germany |
| Prieto-Alhambra D, Judge A, Arden NK, Cooper C, Lyles KW, Javaid MK. Fracture prevention in patients with cognitive impairment presenting with a hip fracture: secondary analysis of data from the HORIZON Recurrent Fracture Trial. Osteoporos Int. 2014 Jan;25(1):77-83. doi: 10.1007/s00198-013-2420-8. Epub 2013 Jun 28. |
| 21249332 | Derived | Adachi JD, Lyles KW, Colon-Emeric CS, Boonen S, Pieper CF, Mautalen C, Hyldstrup L, Recknor C, Nordsletten L, Moore KA, Bucci-Rechtweg C, Su G, Eriksen EF, Magaziner JS. Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON-Recurrent Fracture Trial. Osteoporos Int. 2011 Sep;22(9):2539-49. doi: 10.1007/s00198-010-1514-9. Epub 2011 Jan 20. |
| 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. |
| 17878149 | Derived | Lyles KW, Colon-Emeric CS, Magaziner JS, Adachi JD, Pieper CF, Mautalen C, Hyldstrup L, Recknor C, Nordsletten L, Moore KA, Lavecchia C, Zhang J, Mesenbrink P, Hodgson PK, Abrams K, Orloff JJ, Horowitz Z, Eriksen EF, Boonen S; HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007 Nov 1;357(18):1799-809. doi: 10.1056/NEJMoa074941. Epub 2007 Sep 17. |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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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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