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Can a One-Time bone drug shield Parkinson's patients from fractures?

NCT ID NCT03924414

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a single infusion of zoledronic acid (Reclast) can prevent fractures in men and women aged 60 and older with Parkinson's disease or related conditions. Over 2,700 participants were randomly assigned to receive either the drug or a placebo, and were followed for at least two years. The trial was conducted at home to make participation easier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zoledronic acid (Reclast)
What this could lead to
If it works, this could provide a simple, one-time treatment to reduce fracture risk in older adults with Parkinson's disease.
What could go wrong
This is a completed Phase 4 trial, but results are not yet published. The benefit may be modest, and zoledronic acid can cause side effects like flu-like symptoms or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,721 people

The number who actually took part.

Started

Nov 2019

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Booth Gardner Parkinson's Care Center at EvergreenHealth

    Kirkland, Washington, 98034, United States

  • Boston University

    Boston, Massachusetts, 02215, United States

  • Case Western Reserve University, UH Cleveland

    Cleveland, Ohio, 44106, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Columbia University

    New York, New York, 10032, United States

  • Cook County Health & Hospitals System

    Chicago, Illinois, 60612, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Duke University

    Durham, North Carolina, 27708, United States

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Hartford Healthcare

    Hartford, Connecticut, 06103, United States

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Loma Linda University

    Loma Linda, California, 92350, United States

  • Loyola University

    Chicago, Illinois, 60660, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Michigan State University

    East Lansing, Michigan, 48824, United States

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310, United States

  • Mount Sinai Beth Israel

    New York, New York, 10019, United States

  • New York University Langone Health

    New York, New York, 10017, United States

  • Northwell Health

    Glen Cove, New York, 11542, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • Ochsner Health System

    New Orleans, Louisiana, 70119, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

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

    Palo Alto, California, 94301, United States

  • Parkinson's Foundation

    Miami, Florida, 33131, United States

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708, United States

  • Queens Medical Center

    Honolulu, Hawaii, 96813, United States

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501, United States

  • Stony Brook University Medical Center

    East Setauket, New York, 11733, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Sutter Health

    Berkeley, California, 94705, United States

  • Sutter Health

    Sacramento, California, 95816, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, Davis

    Sacramento, California, 95816, United States

  • University of California, Irvine

    Irvine, California, 92697, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, Riverside

    Riverside, California, 92521, United States

  • University of California, San Francisco

    San Francisco, California, 94115, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado, Denver

    Aurora, Colorado, 80045, United States

  • University of Connecticut

    Farmington, Connecticut, 06030, United States

  • University of Connecticut

    Farmington, Connecticut, 06032, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Houston Medical Center

    Houston, Texas, 77030, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Vermont

    Burlington, Vermont, 05405, United States

  • University of Wisconsin

    Madison, Wisconsin, 53706, United States

  • Valley Parkinson Clinic

    Los Gatos, California, 95032, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37240, United States

  • Veracity Neuroscience LLC

    Memphis, Tennessee, 38157, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27109, United States

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.