HORIZON-PFT: Pivotal Fracture Trial
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00049829
Collaborator
(none)
7,700
60
128.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
HORIZON-PFT: Pivotal Fracture Trial
Study Start Date
:
Jan 1, 2002
Actual Primary Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
- Incidence of hip fxs []
- Incidence of new vertebral fxs []
Secondary Outcome Measures
- Percent change in hip BMD []
- New and/or worsening vertebral fxs []
- All clinical fxs []
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
to 89 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35205 |
| 2 | Arizona Arthritis Research | Paradise Valley | Arizona | United States | 85253 |
| 3 | Southern Arizona VA | Tucson | Arizona | United States | 85723 |
| 4 | University of Arkansas for Medical Science | Little Rock | Arkansas | United States | 72205 |
| 5 | Osteoporosis Medical Center | Beverly Hills | California | United States | 90211 |
| 6 | Orthopaedic Hospital | Los Angeles | California | United States | 90007 |
| 7 | The Foundation for Osteoporosis Research and Education | Oakland | California | United States | 94612 |
| 8 | University of California Davis- Gen Med Research | Sacramento | California | United States | 95817 |
| 9 | Osteoporosis Prevention Center | San Diego | California | United States | 92103 |
| 10 | Radiant Research- San Diego | San Diego | California | United States | 92108 |
| 11 | Diablo Clinical Research, Inc | Walnut Creek | California | United States | 94598 |
| 12 | Colorado Center for Bone Research | Lakewood | Colorado | United States | 80227 |
| 13 | Longmont Medical Research Network | Longmont | Colorado | United States | 80501 |
| 14 | Northeast Clinical Research | Hamden | Connecticut | United States | 06518-3272 |
| 15 | Health Core | Newark | Delaware | United States | 19713-2072 |
| 16 | CRA Research | Ft. Lauderdale | Florida | United States | 33334 |
| 17 | Anchor Research Center | Naples | Florida | United States | 34102 |
| 18 | Sarasota Arthritis Center | Sarasota | Florida | United States | 34239 |
| 19 | Radiant | Stuart | Florida | United States | 34996 |
| 20 | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | United States | 33409 |
| 21 | Palm Beach Research Center | West Palm Beach | Florida | United States | 33409 |
| 22 | United Osteoporosis Centers (UOC) | Gainesville | Georgia | United States | 30501 |
| 23 | Northwestern University Center for Clinical Research | Chicago | Illinois | United States | 60611 |
| 24 | School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 25 | Medical Specialists | Munster | Indiana | United States | 46321 |
| 26 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
| 27 | Center for Arthritis and Osteoporosis | Elizabethtown | Kentucky | United States | 42701 |
| 28 | Maine Center for Osteoporosis Research and Education | Bangor | Maine | United States | 04401 |
| 29 | Osteoporosis Clinical Trial Center | Hagerstown | Maryland | United States | 21740 |
| 30 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 31 | Clinical Pharmacology Study Groups | Worcester | Massachusetts | United States | 01610 |
| 32 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
| 33 | Arthritis Regional Research Center | Mercerville | New Jersey | United States | 08619 |
| 34 | Phoenix OB-GYN Associates, LLC | Moorestown | New Jersey | United States | 08057 |
| 35 | New Mexico Clinical Research and Osteoporosis Center, Inc | Albuquerque | New Mexico | United States | 87106 |
| 36 | Endwell Family Physicians | Endwell | New York | United States | 13760 |
| 37 | Winthrop U Hospital | Mineola | New York | United States | 11501 |
| 38 | Internal Medicine Associates | Fargo | North Dakota | United States | 58104 |
| 39 | University of Cincinnati Bone Health and Osteoporosis Center | Cincinnati | Ohio | United States | 45219 |
| 40 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 41 | Oregon Health and Science University | Portland | Oregon | United States | 97201 |
| 42 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 43 | Einstein | Philadelphia | Pennsylvania | United States | 19115 |
| 44 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19131 |
| 45 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15261 |
| 46 | Radiant | Wyomissing | Pennsylvania | United States | 19610 |
| 47 | Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit | Providence | Rhode Island | United States | 02903 |
| 48 | Roger William Medical Center | Providence | Rhode Island | United States | 02908 |
| 49 | Avera Research Institute | Sioux Falls | South Dakota | United States | 57105 |
| 50 | University of Tennessee Health Science | Memphis | Tennessee | United States | 38105 |
| 51 | West Cancer Clinic | Memphis | Tennessee | United States | 38120 |
| 52 | Diabetes Regional Research Center | Midland | Texas | United States | 79705 |
| 53 | Sam Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 54 | University of Texas Health Center at Tyler -Center for Clinical Research | Tyler | Texas | United States | 75708 |
| 55 | Hampton Roads Center for Clinical Research, Inc | Norfolk | Virginia | United States | 23502 |
| 56 | McGuire Veterans Affairs Medical Center | Richmond | Virginia | United States | 23249 |
| 57 | VA Commonwealth University | Richmond | Virginia | United States | 23298 |
| 58 | Osteoporosis Research Unit | Seattle | Washington | United States | 98144 |
| 59 | The Physicians Clinic | Spokane | Washington | United States | 99204 |
| 60 | Novartis | Nuernberg | Germany |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00049829
Other Study ID Numbers:
- CZOL446H2301
First Posted:
Nov 15, 2002
Last Update Posted:
Nov 2, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: