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Bisphosphonate

Zoledronic Acid for Parkinson's Disease (TOPAZ Trial)

Phase 4
Recruiting
Led By Steve Cummings, MD
Research Sponsored by California Pacific Medical Center Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women age 60 years or older
Men and women age 60 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

TOPAZ Trial Summary

This trial is testing whether a single infusion of zoledronic acid can help prevent fractures in people with Parkinson's disease or parkinsonism. A total of 3500 participants will be enrolled in the United States.

Who is the study for?
This trial is for men and women aged 60 or older with Parkinson's disease or parkinsonism, who can follow the study for at least 2 years. They must be able to consent and have a neurologist-confirmed diagnosis. People using bisphosphonates in the last year, those with recent or planned dental procedures, on osteoporosis treatments within 6 months, undergoing dialysis, non-ambulatory individuals, or with certain other diseases are excluded.Check my eligibility
What is being tested?
The study tests if a single infusion of Zoledronic Acid (ZA) can prevent fractures compared to a placebo in patients with Parkinson's-related conditions. It's randomized and blinded—meaning neither participants nor researchers know who gets ZA or placebo—and involves over three thousand participants across the U.S.See study design
What are the potential side effects?
Zoledronic Acid may cause flu-like symptoms such as fever and chills, pain at the injection site, nausea, anemia (low red blood cell count), headache, dizziness; rarely it might lead to jaw bone problems (osteonecrosis) or unusual thigh bone fractures.

TOPAZ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I am 60 years old or older.
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I have been diagnosed with Parkinson's Disease or parkinsonism by a neurologist.
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I have been diagnosed with Parkinson's Disease or a similar condition by a specialist.
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I have been diagnosed with Parkinson's Disease or a similar condition by a neurologist.
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I am 60 years old or older.
Select...
I am 60 years old or older.
Select...
I have been diagnosed with Parkinson's Disease or a similar condition by a specialist.

TOPAZ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Clinical Fractures
Secondary outcome measures
Mortality
Number of Participants Hip Fractures

TOPAZ Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Zoledronic acid (ZA)Active Control1 Intervention
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Group II: PlaceboPlacebo Group1 Intervention
A single intravenous infusion of placebo infused over 45 minutes

Find a Location

Who is running the clinical trial?

California Pacific Medical Center Research InstituteLead Sponsor
43 Previous Clinical Trials
9,026 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,000,999 Total Patients Enrolled
University of California, San FranciscoOTHER
2,496 Previous Clinical Trials
11,929,989 Total Patients Enrolled

Media Library

Zoledronic Acid (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT03924414 — Phase 4
Parkinson's Disease Research Study Groups: Zoledronic acid (ZA), Placebo
Parkinson's Disease Clinical Trial 2023: Zoledronic Acid Highlights & Side Effects. Trial Name: NCT03924414 — Phase 4
Zoledronic Acid (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03924414 — Phase 4
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03924414 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this clinical research program?

"In order for this clinical trial to commence, 3500 participants must be recruited that meet specified criteria. Those interested in taking part can attend Valley Parkinson Clinic in Los Gatos California or Cook County Health & Hospitals System in Chicago Illinois."

Answered by AI

What is the geographical expanse of this research endeavor?

"Valley Parkinson Clinic in Los Gatos, California, Cook County Health & Hospitals System located in Chicago, Illinois and Northwell Health based out of Great Neck, New york are among the 55 sites running this medical trial."

Answered by AI

What pathologies has Zoledronic acid been demonstrated to be effective at ameliorating?

"Zoledronic acid (ZA) is generally used to combat malignant tumours and other illnesses such as low bone mineral density, chemotherapy, or osteoporosis."

Answered by AI

What former studies have utilized Zoledronic acid (ZA) as a therapeutic agent?

"Currently, there are 36 studies exploring the effects of Zoledronic acid (ZA). 8 of these trials have advanced to Phase 3. Although most research is conducted at Douliu in Yunlin County, 694 medical centres around the world are running experiments with this drug."

Answered by AI

Has Zoledronic acid (ZA) been sanctioned by the FDA?

"With Phase 4 trials backing its use, the safety of Zoledronic acid (ZA) has been assessed as a 3 on our scale."

Answered by AI

Are there still individuals being included in this research project?

"Affirmative. According to information from clinicaltrials.gov, this medical study commenced on November 15th 2019 and is still actively recruiting participants. An estimated 3500 patients will be taken in at 55 distinct sites for the trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Florida
Other
California
What site did they apply to?
University of California, Los Angeles
Weill Cornell Medicine
Duke University
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I thought it was interesting. Para pruebas de osteoporosis. falls are getting more frequent.
PatientReceived no prior treatments
I am positive that something will cure MSA.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of California, Irvine: < 48 hours
Average response time
  • < 2 Days
~1041 spots leftby Feb 2026