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Parkinson DiseasePhase 4TOPAZNCT03924414

Trial of Parkinson's And Zoledronic Acid

A Phase 4 study testing Zoledronic Acid 5Mg/Bag 100Ml Inj in people with Parkinson Disease and Osteoporosis, run by California Pacific Medical Center Research Institute at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Parkinson Disease, Osteoporosis, Parkinsonism
What is being tested?
Zoledronic Acid 5Mg/Bag 100Ml Inj
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,721 participants
Where
77 sitesUnited States
Study dates
15 Nov 2019to 28 Feb 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Albany Medical College

    Albany, New York, 12208

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • Sutter Health

    Berkeley, California, 94705

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boston University

    Boston, Massachusetts, 02215

  • University of Vermont

    Burlington, Vermont, 05405

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • Cook County Health & Hospitals System

    Chicago, Illinois, 60612

  • Rush University

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Loyola University

    Chicago, Illinois, 60660

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Case Western Reserve University, UH Cleveland

    Cleveland, Ohio, 44106

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27708

  • Michigan State University

    East Lansing, Michigan, 48824

  • Stony Brook University Medical Center

    East Setauket, New York, 11733

  • University of Connecticut

    Farmington, Connecticut, 06030

  • University of Connecticut

    Farmington, Connecticut, 06032

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • University of Florida

    Gainesville, Florida, 32611

  • Northwell Health

    Glen Cove, New York, 11542

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

  • Northwell Health

    Great Neck, New York, 11021

  • Hartford Healthcare

    Hartford, Connecticut, 06103

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141

  • Queens Medical Center

    Honolulu, Hawaii, 96813

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • University of Texas Health Houston Medical Center

    Houston, Texas, 77030

  • University of California, Irvine

    Irvine, California, 92697

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Booth Gardner Parkinson's Care Center at EvergreenHealth

    Kirkland, Washington, 98034

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • University of Kentucky

    Lexington, Kentucky, 40506

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University

    Loma Linda, California, 92350

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Valley Parkinson Clinic

    Los Gatos, California, 95032

  • University of Wisconsin

    Madison, Wisconsin, 53706

  • Northwell Health

    Manhasset, New York, 11030

  • Veracity Neuroscience LLC

    Memphis, Tennessee, 38157

  • Parkinson's Foundation

    Miami, Florida, 33131

  • University of Miami

    Miami, Florida, 33146

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37240

  • Ochsner Health System

    New Orleans, Louisiana, 70119

  • New York University Langone Health

    New York, New York, 10017

  • Mount Sinai Beth Israel

    New York, New York, 10019

  • Columbia University

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Parkinson's Disease and Movement Disorder Center of Silicon Valley

    Palo Alto, California, 94301

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California, Riverside

    Riverside, California, 92521

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Sutter Health

    Sacramento, California, 95816

  • University of California, Davis

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of California, San Francisco

    San Francisco, California, 94115

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Wake Forest University

    Winston-Salem, North Carolina, 27109

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Zoledronic Acid 5Mg/Bag 100Ml Inj, Placebo
Keywords
Parkinson Disease, Parkinson's Disease, Osteoporosis, Zoledronic acid, Neurology, Bone, Fracture, Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia with Lewy Bodies
Medical subject headings
Parkinson Disease, Osteoporosis, Parkinsonian Disorders, Supranuclear Palsy, Progressive, Multiple System Atrophy, Lewy Body Disease, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic Acid 5Mg/Bag 100Ml InjDrug

    Also called Reclast

    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.

  • PlaceboOther

    Normal Saline 100 ml (placebo) IV infusion

Study groups in NCT03924414
Study groupRoleWhat they receive
Zoledronic acid (ZA)Active comparatorA single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Receives: Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
PlaceboPlacebo comparatorA single intravenous infusion of placebo infused over 45 minutes
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Clinical Fractures

    All clinical fractures

    Measured: 2 years

  2. Number of Participants with Clinical Fractures

    All clinical fractures

    Measured: 5 years

Secondary outcomes (4)

  1. Number of Participants Hip Fractures

    Hip fractures

    Measured: 2 years

  2. Number of Participants Hip Fractures

    Hip fractures

    Measured: 5 years

  3. Mortality

    All-cause mortality

    Measured: 2 years

  4. Mortality

    All-cause mortality

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start15 Nov 2019
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This 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 or parkinsonism with at least 2 years of follow-up.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,721 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03924414
Sponsor's protocol ID
20180456
Other IDs
1R01AG059417-01A1
Acronym
TOPAZ
Status last verified
Jun 2026
First submitted
2 Apr 2019
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tanner CM, Cummings SR, Schwarzschild MA, Brown EG, Dorsey ER, Espay AJ, Galifianakis NB, Goldman SM, Litvan I, Luthra N, McFarland NR, Mitchell KT, Standaert DG, Bauer DC, Greenspan SL, Beck JC, Lyles KW. The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism. NPJ Parkinsons Dis. 2021 Mar 1;7(1):16. doi: 10.1038/s41531-021-00162-1.

    PubMed 33649343

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoledronic Acid 5Mg/Bag 100Ml Inj in people with Parkinson Disease and Osteoporosis, run by California Pacific Medical Center Research Institute at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Clinical Fractures (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03924414, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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