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Trial of Parkinson's And Zoledronic Acid
Sponsor: California Pacific Medical Center Research Institute
Summary
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 2650 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
Official title: TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2650
Start Date
2019-11-15
Completion Date
2025-10-31
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
Zoledronic Acid 5Mg/Bag 100Ml Inj
Zoledronic acid 5mg/100 ml IV infusion: Zoledronic acid-5 mg (ZA) is an FDA approved therapy for men and postmenopausal women for the treatment and prevention of osteoporosis.
Placebo
Normal Saline 100 ml (placebo) IV infusion
Locations (77)
Mayo Clinic
Scottsdale, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Health
Berkeley, California, United States
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
University of California, Irvine
Irvine, California, United States
Loma Linda University
Loma Linda, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Valley Parkinson Clinic
Los Gatos, California, United States
Parkinson's Disease and Movement Disorder Center of Silicon Valley
Palo Alto, California, United States
University of California, Riverside
Riverside, California, United States
Sutter Health
Sacramento, California, United States
University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
St. Mary's Medical Center
Grand Junction, Colorado, United States
University of Connecticut
Farmington, Connecticut, United States
University of Connecticut
Farmington, Connecticut, United States
Hartford Healthcare
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Parkinson's Foundation
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Queens Medical Center
Honolulu, Hawaii, United States
Northwestern Medicine
Chicago, Illinois, United States
Cook County Health & Hospitals System
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University
Chicago, Illinois, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Health System
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
Stony Brook University Medical Center
East Setauket, New York, United States
Northwell Health
Glen Cove, New York, United States
Northwell Health
Great Neck, New York, United States
Northwell Health
Manhasset, New York, United States
New York University Langone Health
New York, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University, UH Cleveland
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Veracity Neuroscience LLC
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
University of Texas Health Houston Medical Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
Booth Gardner Parkinson's Care Center at EvergreenHealth
Kirkland, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States