DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



HORIZON-PFT: Pivotal Fracture Trial

Information source: Novartis
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Zoledronic Acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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.

Clinical Details

Official title: HORIZON-PFT: Pivotal Fracture Trial

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Incidence of hip fxs

Incidence of new vertebral fxs

Secondary outcome:

Percent change in hip BMD

New and/or worsening vertebral fxs

All clinical fxs

Eligibility

Minimum age: 65 Years. Maximum age: 89 Years. Gender(s): Female.

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.

Locations and Contacts

Novartis, Nuernberg, Germany

University of Alabama at Birmingham, Birmingham, Alabama 35205, United States

Arizona Arthritis Research, 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 Prevention Center, San Diego, California 92103, United States

University of California Davis- Gen Med Research, Sacramento, California 95817, United States

Orthopaedic Hospital, Los Angeles, California 90007, United States

The Foundation for Osteoporosis Research and Education, Oakland, California 94612, United States

Osteoporosis Medical Center, Beverly Hills, California 90211, 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

Comprehensive Clinical Trials, LLC, West Palm Beach, Florida 33409, United States

Anchor Research Center, Naples, Florida 34102, United States

Radiant, Stuart, Florida 34996, United States

Sarasota Arthritis Center, Sarasota, Florida 34239, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

CRA Research, Ft. Lauderdale, Florida 33334, United States

United Osteoporosis Centers (UOC), Gainesville, Georgia 30501, United States

Northwestern University Center for Clinical Research, Chicago, Illinois 60611, United States

Medical Specialists, Munster, Indiana 46321, United States

School of Medicine, Indianapolis, Indiana 46202, 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

Clinical Pharmacology Study Groups, Worcester, Massachusetts 01610, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, 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

Winthrop U Hospital, Mineola, New York 11501, United States

Endwell Family Physicians, Endwell, New York 13760, United States

Internal Medicine Associates, Fargo, North Dakota 58104, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

University of Cincinnati Bone Health and Osteoporosis Center, Cincinnati, Ohio 45219, United States

Oregon Health and Science University, Portland, Oregon 97201, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19131, United States

Radiant, Wyomissing, Pennsylvania 19610, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Einstein, Philadelphia, Pennsylvania 19115, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15261, 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

McGuire Veterans Affairs Medical Center, Richmond, Virginia 23249, United States

VA Commonwealth University, Richmond, Virginia 23298, United States

Hampton Roads Center for Clinical Research, Inc, Norfolk, Virginia 23502, United States

The Physicians Clinic, Spokane, Washington 99204, United States

Osteoporosis Research Unit, Seattle, Washington 98144, United States

Additional Information

Starting date: January 2002
Last updated: October 9, 2007

Page last updated: December 31, 2007

-- advertisement -- The American Red Cross
We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2009