Trial of Parkinson's And Zoledronic Acid

NCT03924414 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 201804561R01AG059417-01A1
• Study Type: interventional
• Target: 2,650
• Locations: 1 country
• Sites: 77

Brief 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 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.

Conditions

Parkinson Disease; Osteoporosis; Parkinsonism; Parkinson's Disease and Parkinsonism; Atypical Parkinsonism; Progressive Supranuclear Palsy; Multiple System Atrophy; Vascular Parkinsonism; Dementia With Lewy Bodies

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Clinical Fractures

  All clinical fractures

  2 years

• Number of Participants with Clinical Fractures

  All clinical fractures

  5 years

Secondary Outcomes (4)

• Number of Participants Hip Fractures

  2 years

• Number of Participants Hip Fractures

  5 years

• Mortality

  2 years

• Mortality

  5 years

Study Arms (2)

Zoledronic acid (ZA)

ACTIVE COMPARATOR

A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes

Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj

Placebo

PLACEBO COMPARATOR

A single intravenous infusion of placebo infused over 45 minutes

Other: Placebo

Interventions

Zoledronic Acid 5Mg/Bag 100Ml Inj DRUG

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.

Also known as: Reclast

Zoledronic acid (ZA)

Placebo OTHER

Normal Saline 100 ml (placebo) IV infusion

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead
• National Institute on Aging (NIA): collaborator
• University of California, San Francisco: collaborator
• Duke University: collaborator
• University of Pittsburgh: collaborator
• Parkinson's Foundation: collaborator

Study Sites (77)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Sutter Health

Berkeley, California, 94705, United States

Location

Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Loma Linda University

Loma Linda, California, 92350, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Valley Parkinson Clinic

Los Gatos, California, 95032, United States

Location

Parkinson's Disease and Movement Disorder Center of Silicon Valley

Palo Alto, California, 94301, United States

Location

University of California, Riverside

Riverside, California, 92521, United States

Location

Sutter Health

Sacramento, California, 95816, United States

Location

University of California, Davis

Sacramento, California, 95816, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

St. Mary's Medical Center

Grand Junction, Colorado, 81501, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

University of Connecticut

Farmington, Connecticut, 06032, United States

Location

Hartford Healthcare

Hartford, Connecticut, 06103, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Parkinson's Foundation

Miami, Florida, 33131, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Queens Medical Center

Honolulu, Hawaii, 96813, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Cook County Health & Hospitals System

Chicago, Illinois, 60612, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University

Chicago, Illinois, 60660, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70119, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Stony Brook University Medical Center

East Setauket, New York, 11733, United States

Location

Northwell Health

Glen Cove, New York, 11542, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

New York University Langone Health

New York, New York, 10017, United States

Location

Mount Sinai Beth Israel

New York, New York, 10019, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University, UH Cleveland

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Veracity Neuroscience LLC

Memphis, Tennessee, 38157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

University of Texas Health Houston Medical Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Booth Gardner Parkinson's Care Center at EvergreenHealth

Kirkland, Washington, 98034, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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.

  PMID: 33649343 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Osteoporosis; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Multiple System Atrophy; Lewy Body Disease; Fractures, Bone

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Dementia; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Steve Cummings, MD

  CPMC Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 23, 2019
• Study Start: November 15, 2019
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (77)