Trial of Parkinson's And Zoledronic Acid

Completed · Phase 4 · Has a placebo group

Conditions studied: Parkinson Disease, Osteoporosis, Parkinsonism, Parkinson's Disease and Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia With Lewy Bodies

In brief

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.

Key facts

Study ID

NCT03924414

Run by

California Pacific Medical Center Research Institute

People needed

2721

Starts

2019-11-15

Expected to finish

2026-02-28

Last updated by the study team

2026-06-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sutter Health — Berkeley, California, United States
• Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• University of California, Irvine — Irvine, California, United States
• Loma Linda University — Loma Linda, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Valley Parkinson Clinic — Los Gatos, California, United States
• Parkinson's Disease and Movement Disorder Center of Silicon Valley — Palo Alto, California, United States
• University of California, Riverside — Riverside, California, United States
• Sutter Health — Sacramento, California, United States
• University of California, Davis — Sacramento, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• St. Mary's Medical Center — Grand Junction, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• University of Connecticut — Farmington, Connecticut, United States
• Hartford Healthcare — Hartford, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Parkinson's Foundation — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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