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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
Current Parkinson's Disease diagnosis or neurodegenerative parkinsonism diagnosis based on an expert assessment (neurologist diagnosis via medical records confirmation or Telemedicine Screening Assessment)
Must not have
Non-ambulatory, i.e., unable to walk without assistance of another person
Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal 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.
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.
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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need someone's help to walk.
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I haven't had nor plan to have any tooth extractions or major dental work soon.
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I am currently receiving kidney dialysis.
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I have been diagnosed with multiple myeloma or Paget's disease.
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I haven't taken any osteoporosis treatments in the last 6 months.
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I have had a hip fracture in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Clinical Fractures
Secondary study objectives
Mortality
Number of Participants Hip Fractures

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
7,981 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,801 Previous Clinical Trials
28,190,407 Total Patients Enrolled
296 Trials studying Dementia
23,632,066 Patients Enrolled for Dementia
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,884,480 Total Patients Enrolled
34 Trials studying Dementia
200,164 Patients Enrolled for Dementia
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,965,336 Total Patients Enrolled
20 Trials studying Dementia
38,219 Patients Enrolled for Dementia
University of PittsburghOTHER
1,791 Previous Clinical Trials
16,356,296 Total Patients Enrolled
10 Trials studying Dementia
3,119 Patients Enrolled for Dementia
Parkinson's FoundationOTHER
11 Previous Clinical Trials
1,027,384 Total Patients Enrolled
Steve Cummings, MDPrincipal InvestigatorCPMC Research Institute

Media Library

Zoledronic Acid (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT03924414 — Phase 4
Dementia Research Study Groups: Zoledronic acid (ZA), Placebo
Dementia 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
Dementia Patient Testimony for trial: Trial Name: NCT03924414 — Phase 4
~615 spots leftby Feb 2026
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