HORIZON-PFT: Pivotal Fracture Trial
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Osteoporosis |
| Intervention | Drug: Zoledronic Acid |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Responsible Party | Novartis |
| ClinicalTrials.gov Identifier | NCT00049829 |
| First Received | November 14, 2002 |
| Last Updated | November 1, 2011 |
| Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 14, 2002 |
|---|---|
| Last Updated Date | November 1, 2011 |
| Start Date | January 2002 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | HORIZON-PFT: Pivotal Fracture Trial |
|---|---|
| Official Title | HORIZON-PFT: Pivotal Fracture Trial |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Osteoporosis |
| Intervention | Drug: Zoledronic Acid |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 7700 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2006 |
| 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. |
| Gender | Female |
| Ages | 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00049829 |
|---|---|
| Other Study ID Numbers | CZOL446H2301 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Novartis |
| Study Sponsor | Novartis Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | November 2011 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham | Birmingham, Alabama, United States, 35205 |
|---|---|
| Arizona Arthritis Research | Paradise Valley, Arizona, United States, 85253 |
| Southern Arizona VA | Tucson, Arizona, United States, 85723 |
| University of Arkansas for Medical Science | Little Rock, Arkansas, United States, 72205 |
| Osteoporosis Medical Center | Beverly Hills, California, United States, 90211 |
| Orthopaedic Hospital | Los Angeles, California, United States, 90007 |
| The Foundation for Osteoporosis Research and Education | Oakland, California, United States, 94612 |
| University of California Davis- Gen Med Research | Sacramento, California, United States, 95817 |
| Osteoporosis Prevention Center | San Diego, California, United States, 92103 |
| Radiant Research- San Diego | San Diego, California, United States, 92108 |
| Diablo Clinical Research, Inc | Walnut Creek, California, United States, 94598 |
| Colorado Center for Bone Research | Lakewood, Colorado, United States, 80227 |
| Longmont Medical Research Network | Longmont, Colorado, United States, 80501 |
| Northeast Clinical Research | Hamden, Connecticut, United States, 06518-3272 |
| Health Core | Newark, Delaware, United States, 19713-2072 |
| CRA Research | Ft. Lauderdale, Florida, United States, 33334 |
| Anchor Research Center | Naples, Florida, United States, 34102 |
| Sarasota Arthritis Center | Sarasota, Florida, United States, 34239 |
| Radiant | Stuart, Florida, United States, 34996 |
| Palm Beach Research Center | West Palm Beach, Florida, United States, 33409 |
| Comprehensive Clinical Trials, LLC | West Palm Beach, Florida, United States, 33409 |
| United Osteoporosis Centers (UOC) | Gainesville, Georgia, United States, 30501 |
| Northwestern University Center for Clinical Research | Chicago, Illinois, United States, 60611 |
| School of Medicine | Indianapolis, Indiana, United States, 46202 |
| Medical Specialists | Munster, Indiana, United States, 46321 |
| Heartland Research Associates, LLC | Wichita, Kansas, United States, 67207 |
| Center for Arthritis and Osteoporosis | Elizabethtown, Kentucky, United States, 42701 |
| Maine Center for Osteoporosis Research and Education | Bangor, Maine, United States, 04401 |
| Osteoporosis Clinical Trial Center | Hagerstown, Maryland, United States, 21740 |
| Brigham and Women's Hospital | Boston, Massachusetts, United States, 02115 |
| Clinical Pharmacology Study Groups | Worcester, Massachusetts, United States, 01610 |
| Washington University School of Medicine | St. Louis, Missouri, United States, 63110 |
| Arthritis Regional Research Center | Mercerville, New Jersey, United States, 08619 |
| Phoenix OB-GYN Associates, LLC | Moorestown, New Jersey, United States, 08057 |
| New Mexico Clinical Research and Osteoporosis Center, Inc | Albuquerque, New Mexico, United States, 87106 |
| Endwell Family Physicians | Endwell, New York, United States, 13760 |
| Winthrop U Hospital | Mineola, New York, United States, 11501 |
| Internal Medicine Associates | Fargo, North Dakota, United States, 58104 |
| University of Cincinnati Bone Health and Osteoporosis Center | Cincinnati, Ohio, United States, 45219 |
| Cleveland Clinic Foundation | Cleveland, Ohio, United States, 44195 |
| Oregon Health and Science University | Portland, Oregon, United States, 97201 |
| Altoona Center for Clinical Research | Duncansville, Pennsylvania, United States, 16635 |
| Einstein | Philadelphia, Pennsylvania, United States, 19115 |
| Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, United States, 19131 |
| University of Pittsburgh | Pittsburgh, Pennsylvania, United States, 15261 |
| Radiant | Wyomissing, Pennsylvania, United States, 19610 |
| Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit | Providence, Rhode Island, United States, 02903 |
| Roger William Medical Center | Providence, Rhode Island, United States, 02908 |
| Avera Research Institute | Sioux Falls, South Dakota, United States, 57105 |
| University of Tennessee Health Science | Memphis, Tennessee, United States, 38105 |
| West Cancer Clinic | Memphis, Tennessee, United States, 38120 |
| Diabetes Regional Research Center | Midland, Texas, United States, 79705 |
| Sam Clinical Research Center | San Antonio, Texas, United States, 78229 |
| University of Texas Health Center at Tyler -Center for Clinical Research | Tyler, Texas, United States, 75708 |
| Hampton Roads Center for Clinical Research, Inc | Norfolk, Virginia, United States, 23502 |
| VA Commonwealth University | Richmond, Virginia, United States, 23298 |
| McGuire Veterans Affairs Medical Center | Richmond, Virginia, United States, 23249 |
| Osteoporosis Research Unit | Seattle, Washington, United States, 98144 |
| The Physicians Clinic | Spokane, Washington, United States, 99204 |
| Novartis | Nuernberg, Germany |