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

Who is this study for? Adult patients over age 60 with Parkinson's disease
What treatments are being studied? Zoledronic Acid
Status: Active_not_recruiting
Location: See all (77) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Men and women age 60 years or older

• Current Parkinson's Disease diagnosis or neurodegenerative parkinsonism diagnosis (including progressive supranuclear palsy, multiple system atrophy, cortical basal degeneration, vascular parkinsonism, dementia with Lewy bodies or another form of neurodegenerative parkinsonism) based on an expert assessment (neurologist diagnosis via medical records confirmation or Telemedicine Screening Assessment)

• Willing and able to continue in follow-up for at least 2 years

• Willing and able to provide informed consent

Locations
United States
Arkansas
Washington Regional Medical Center
Fayetteville
University of Arkansas for Medical Sciences
Little Rock
Arizona
Mayo Clinic
Scottsdale
California
Sutter Health
Berkeley
Parkinson's and Movement Disorder Institute
Fountain Valley
University of California, Irvine
Irvine
Loma Linda University
Loma Linda
Cedars-Sinai Medical Center
Los Angeles
University of California, Los Angeles
Los Angeles
Valley Parkinson Clinic
Los Gatos
Parkinson's Disease and Movement Disorder Center of Silicon Valley
Palo Alto
University of California, Riverside
Riverside
Sutter Health
Sacramento
University of California, Davis
Sacramento
University of California, San Francisco
San Francisco
Colorado
University of Colorado, Denver
Aurora
St. Mary's Medical Center
Grand Junction
Connecticut
University of Connecticut
Farmington
University of Connecticut
Farmington
Hartford Healthcare
Hartford
Florida
University of Florida
Gainesville
Mayo Clinic
Jacksonville
Parkinson's Foundation
Miami
University of Miami
Miami
Georgia
Emory University School of Medicine
Atlanta
Morehouse School of Medicine
Atlanta
Augusta University
Augusta
Hawaii
Queens Medical Center
Honolulu
Illinois
Cook County Health & Hospitals System
Chicago
Loyola University
Chicago
Northwestern Medicine
Chicago
Rush University
Chicago
University of Chicago
Chicago
Edward Hines, Jr. VA Hospital
Hines
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky
Lexington
Louisiana
Ochsner Health System
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Boston University
Boston
Massachusetts General Hospital
Boston
Michigan
Michigan State University
East Lansing
Quest Research Institute
Farmington Hills
Minnesota
Mayo Clinic
Rochester
North Carolina
Duke University
Durham
Wake Forest University
Winston-salem
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New York
Albany Medical College
Albany
Stony Brook University Medical Center
East Setauket
Northwell Health
Glen Cove
Northwell Health
Great Neck
Northwell Health
Manhasset
Columbia University
New York
Mount Sinai Beth Israel
New York
New York University Langone Health
New York
Weill Cornell Medicine
New York
University of Rochester
Rochester
Stony Brook University Medical Center
Stony Brook
Ohio
University of Cincinnati
Cincinnati
Case Western Reserve University, UH Cleveland
Cleveland
The Ohio State University
Columbus
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Thomas Jefferson University
Philadelphia
University of Pennsylvania
Philadelphia
University of Pittsburgh
Pittsburgh
Lankenau Medical Center
Wynnewood
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Veracity Neuroscience LLC
Memphis
Vanderbilt University Medical Center
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Houston Methodist Neurological Institute
Houston
University of Texas Health Houston Medical Center
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Utah
Intermountain Medical Center
Murray
University of Utah
Salt Lake City
Vermont
University of Vermont
Burlington
Washington
Booth Gardner Parkinson's Care Center at EvergreenHealth
Kirkland
Wisconsin
University of Wisconsin
Madison
Time Frame
Start Date: 2019-11-15
Completion Date: 2025-10-31
Participants
Target number of participants: 2650
Treatments
Active_comparator: Zoledronic acid (ZA)
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Placebo_comparator: Placebo
A single intravenous infusion of placebo infused over 45 minutes
Authors
Peter Lin, Caroline Tanner, Kathleen Shannon, Mark LeDoux, Mustafa Siddiqui, Salima Brillman
Related Therapeutic Areas
Progressive Supranuclear Palsy Atypical
Brown Syndrome
Movement Disorders
Familial Dysautonomia
Progressive Supranuclear Palsy
Parkinson's Disease
Ring Chromosome 6
Postmenopausal Osteoporosis
Multiple System Atrophy
Dementia
Osteoporosis
Lewy Body Dementia (LBD)
Sponsors
Leads: California Pacific Medical Center Research Institute
Collaborators: University of Pittsburgh, National Institute on Aging (NIA), Duke University, Parkinson's Foundation, University of California, San Francisco

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism

The NADAPT Study: a Randomized Double-blind Trial of NAD Replenishment Therapy for Atypical Parkinsonism

Enrollment Status: Recruiting
Publish Date: January 10, 2025
Intervention Type: Dietary supplement, Other
Study Phase: Phase 2

Evaluation of Supracardiac Venous Angioplasty and Stenting on Ortho- Static Intolerance and Orthostatic Hypotension - The STANDUP Study

Evaluation of Supracardiac Venous Angioplasty and Stenting on Ortho- Static Intolerance and Orthostatic Hypotension - The STANDUP Study

Enrollment Status: Recruiting
Publish Date: September 29, 2025
Intervention Type: Device
Study Phase: Not Applicable

Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers

Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers

Enrollment Status: Recruiting
Publish Date: November 19, 2025
Intervention Type: Other
Study Phase: Early Phase 1
View All