HORIZON-PFT: Pivotal Fracture Trial

Osteoporosis Clinical Trial

Official title:

HORIZON-PFT: Pivotal Fracture Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049829
• Other study ID #: CZOL446H2301
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2002
• Last updated: November 1, 2011
• Start date: January 2002

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7700
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Zoledronic Acid

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg
United States	New Mexico Clinical Research and Osteoporosis Center, Inc	Albuquerque	New Mexico
United States	Maine Center for Osteoporosis Research and Education	Bangor	Maine
United States	Osteoporosis Medical Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern University Center for Clinical Research	Chicago	Illinois
United States	University of Cincinnati Bone Health and Osteoporosis Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky
United States	Endwell Family Physicians	Endwell	New York
United States	Internal Medicine Associates	Fargo	North Dakota
United States	CRA Research	Ft. Lauderdale	Florida
United States	United Osteoporosis Centers (UOC)	Gainesville	Georgia
United States	Osteoporosis Clinical Trial Center	Hagerstown	Maryland
United States	Northeast Clinical Research	Hamden	Connecticut
United States	School of Medicine	Indianapolis	Indiana
United States	Colorado Center for Bone Research	Lakewood	Colorado
United States	University of Arkansas for Medical Science	Little Rock	Arkansas
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Orthopaedic Hospital	Los Angeles	California
United States	University of Tennessee Health Science	Memphis	Tennessee
United States	West Cancer Clinic	Memphis	Tennessee
United States	Arthritis Regional Research Center	Mercerville	New Jersey
United States	Diabetes Regional Research Center	Midland	Texas
United States	Winthrop U Hospital	Mineola	New York
United States	Phoenix OB-GYN Associates, LLC	Moorestown	New Jersey
United States	Medical Specialists	Munster	Indiana
United States	Anchor Research Center	Naples	Florida
United States	Health Core	Newark	Delaware
United States	Hampton Roads Center for Clinical Research, Inc	Norfolk	Virginia
United States	The Foundation for Osteoporosis Research and Education	Oakland	California
United States	Arizona Arthritis Research	Paradise Valley	Arizona
United States	Einstein	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital, Osteoporosis Research/ Bone Density Unit	Providence	Rhode Island
United States	Roger William Medical Center	Providence	Rhode Island
United States	McGuire Veterans Affairs Medical Center	Richmond	Virginia
United States	VA Commonwealth University	Richmond	Virginia
United States	University of California Davis- Gen Med Research	Sacramento	California
United States	Sam Clinical Research Center	San Antonio	Texas
United States	Osteoporosis Prevention Center	San Diego	California
United States	Radiant Research- San Diego	San Diego	California
United States	Sarasota Arthritis Center	Sarasota	Florida
United States	Osteoporosis Research Unit	Seattle	Washington
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	The Physicians Clinic	Spokane	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Radiant	Stuart	Florida
United States	Southern Arizona VA	Tucson	Arizona
United States	University of Texas Health Center at Tyler -Center for Clinical Research	Tyler	Texas
United States	Diablo Clinical Research, Inc	Walnut Creek	California
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Clinical Pharmacology Study Groups	Worcester	Massachusetts
United States	Radiant	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hip fxs
Primary	Incidence of new vertebral fxs
Secondary	Percent change in hip BMD
Secondary	New and/or worsening vertebral fxs
Secondary	All clinical fxs