Trial of Parkinson's And Zoledronic Acid (TOPAZ)

July 24, 2023 updated by: California Pacific Medical Center Research Institute

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

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 3500 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.

Patients with PD will be recruited throughout the US by participating neurologists and health networks as well as the Parkinson's Foundation. Patients may also self-refer to the study. Interested patients can access study information on a study website (topaz.eurekaplatform.org) as well as through the Parkinson's Foundation Helpline. Patients who wish to enroll will be directed to an interactive electronic consent (eConsent). Following eConsent, participants complete a screening questionnaire (to confirm eligibility), followed by a baseline questionnaire. If a participant is determined to be eligible following these steps, they may be scheduled for a Telemedicine assessment to further confirm the PD or parkinsonism diagnosis, unless they have been referred directly from a participating neurologist. If confirmed, the participant will be mailed a supply of vitamin D3 800-1000 IU and instructed to take one vitamin D tablet every day for 2 months. Lastly, a Nurse Home Visit will be scheduled and conducted to confirm final eligibility, randomization, and administration of the study drug, if appropriate. Participants who are randomized will be contacted every 4 months for at least 2 years to determine if they have had any fractures.

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Washington Regional Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • California
      • Berkeley, California, United States, 94705
        • Recruiting
        • Sutter Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Parkinson's and Movement Disorder Institute
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Loma Linda, California, United States, 92350
        • Not yet recruiting
        • Loma Linda University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Los Gatos, California, United States, 95032
        • Recruiting
        • Valley Parkinson Clinic
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Neng Huang, MD
        • Principal Investigator:
          • Peter Lin, MD
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Parkinson's Disease and Movement Disorder Center of Silicon Valley
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Salima Brillman, MD
      • Riverside, California, United States, 92521
        • Recruiting
        • University of California, Riverside
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Sacramento, California, United States, 95816
        • Recruiting
        • University of California, Davis
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • San Francisco, California, United States, 94115
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Caroline Tanner, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado, Denver
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • University of Connecticut
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Farmington, Connecticut, United States, 06032
        • Recruiting
        • University of Connecticut
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Miami, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Miami, Florida, United States, 33131
        • Recruiting
        • Parkinson's Foundation
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queens Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Cook County Health & Hospitals System
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Hines, Illinois, United States, 60141
        • Recruiting
        • Edward Hines, Jr. VA Hospital
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • Ochsner Health System
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Recruiting
        • Michigan State University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Contact:
          • Research University
          • Phone Number: 800-473-4636
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • East Setauket, New York, United States, 11733
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Glen Cove, New York, United States, 11542
        • Recruiting
        • Northwell Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • New York, New York, United States, 10017
        • Recruiting
        • New York University Langone Health
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Duke University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Kenneth W Lyles, MD
      • Winston-Salem, North Carolina, United States, 27109
        • Recruiting
        • Wake Forest University
        • Principal Investigator:
          • Mustafa Siddiqui, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University, UH Cleveland
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Research Coodinator
          • Phone Number: 800-473-4636
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • University of Pittsburgh
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Robyn E Massa, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Tennessee
      • Memphis, Tennessee, United States, 38157
        • Recruiting
        • Veracity Neuroscience LLC
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Mark Ledoux, MD
      • Nashville, Tennessee, United States, 37240
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Houston Methodist Neurological Institute
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Houston Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • Booth Gardner Parkinson's Care Center at EvergreenHealth
        • Contact:
          • Reseaerch Coordinator
          • Phone Number: 800-473-4636
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Recruiting
        • University of Wisconsin
        • Contact:
          • Research Coordinator
          • Phone Number: 800-473-4636
        • Principal Investigator:
          • Kathleen Shannon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of hip fracture
  • Any use of a bisphosphonate drug within the last 12 months
  • Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last 6 months
  • Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months
  • Non-ambulatory, i.e., unable to walk without assistance of another person.
  • Undergoing kidney dialysis
  • A diagnosis of multiple myeloma or Paget's disease
  • Unable to speak or read English sufficiently to complete informed consent
  • Any other criteria, which would make the patient unsuitable to participate in this study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol addiction)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zoledronic acid (ZA)
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Drug: 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.
Other Names:
  • Reclast
Placebo Comparator: Placebo
A single intravenous infusion of placebo infused over 45 minutes
Other: Placebo
Normal Saline 100 ml (placebo) IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Clinical Fractures
Time Frame: 2 years
All clinical fractures
2 years
Number of Participants with Clinical Fractures
Time Frame: 5 years
All clinical fractures
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Hip Fractures
Time Frame: 2 years
Hip fractures
2 years
Mortality
Time Frame: 2 years
All-cause mortality
2 years
Number of Participants Hip Fractures
Time Frame: 5 years
Hip fractures
5 years
Mortality
Time Frame: 5 years
All-cause mortality
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

University of Pittsburgh
Duke University
National Institute on Aging (NIA)
University of California, San Francisco
Parkinson's Foundation

Investigators

  • Principal Investigator: Steve Cummings, MD, CPMC Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180456
  • 1R01AG059417-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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