Trial of Parkinson's And Zoledronic Acid

Parkinson Disease Clinical Trial

— TOPAZ  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03924414
• Other study ID #: 20180456
• Secondary ID: 1R01AG059417-01A
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2019
• Est. completion date: October 1, 2026

Study information

• Verified date: July 2023
• Source: California Pacific Medical Center Research Institute
• Contact: Dana R Kriesel, MPH, MS
• Phone: (877) 378-6729
• Email: robertdc[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: October 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Atypical Parkinsonism
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease
• Multiple System Atrophy
• Osteoporosis
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders
• Parkinsonism
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive
• Vascular Parkinsonism

Intervention

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:
• Placebo
Normal Saline 100 ml (placebo) IV infusion

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado, Denver	Aurora	Colorado
United States	Sutter Health	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cook County Health & Hospitals System	Chicago	Illinois
United States	Northwestern Medicine	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
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	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Stony Brook University Medical Center	East Setauket	New York
United States	University of Connecticut	Farmington	Connecticut
United States	University of Connecticut	Farmington	Connecticut
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	University of Florida	Gainesville	Florida
United States	Northwell Health	Glen Cove	New York
United States	Northwell Health	Great Neck	New York
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Queens Medical Center	Honolulu	Hawaii
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	University of Texas Health Houston Medical Center	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Booth Gardner Parkinson's Care Center at EvergreenHealth	Kirkland	Washington
United States	University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loma Linda University	Loma Linda	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Valley Parkinson Clinic	Los Gatos	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Northwell Health	Manhasset	New York
United States	Veracity Neuroscience LLC	Memphis	Tennessee
United States	Parkinson's Foundation	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Intermountain Medical Center	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Health System	New Orleans	Louisiana
United States	New York University Langone Health	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Parkinson's Disease and Movement Disorder Center of Silicon Valley	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of California, Riverside	Riverside	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Sutter Health	Sacramento	California
United States	University of California, Davis	Sacramento	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Wake Forest University	Winston-Salem	North Carolina
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	Duke University, National Institute on Aging (NIA), Parkinson's Foundation, University of California, San Francisco, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Clinical Fractures	All clinical fractures	2 years
Primary	Number of Participants with Clinical Fractures	All clinical fractures	5 years
Secondary	Number of Participants Hip Fractures	Hip fractures	2 years
Secondary	Number of Participants Hip Fractures	Hip fractures	5 years
Secondary	Mortality	All-cause mortality	2 years
Secondary	Mortality	All-cause mortality	5 years