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Trial of Parkinson's And Zole...

Trial of Parkinson's And Zoledronic Acid

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Zoledronic acid (ZA)

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

Group Type ACTIVE_COMPARATOR

Zoledronic Acid 5Mg/Bag 100Ml Inj

Intervention Type 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.

Placebo

A single intravenous infusion of placebo infused over 45 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal Saline 100 ml (placebo) IV infusion

Interventions

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Zoledronic Acid 5Mg/Bag 100Ml Inj

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.

Intervention Type DRUG

Placebo

Normal Saline 100 ml (placebo) IV infusion

Intervention Type OTHER

Other Intervention Names

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Reclast

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Cummings, MD

Role: PRINCIPAL_INVESTIGATOR

CPMC Research Institute

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Sutter Health

Berkeley, California, United States

Site Status

Parkinson's and Movement Disorder Institute

Fountain Valley, California, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

Loma Linda University

Loma Linda, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

University of California, Los Angeles

Los Angeles, California, United States

Site Status

Valley Parkinson Clinic

Los Gatos, California, United States

Site Status

Parkinson's Disease and Movement Disorder Center of Silicon Valley

Palo Alto, California, United States

Site Status

University of California, Riverside

Riverside, California, United States

Site Status

Sutter Health

Sacramento, California, United States

Site Status

University of California, Davis

Sacramento, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Colorado, Denver

Aurora, Colorado, United States

Site Status

St. Mary's Medical Center

Grand Junction, Colorado, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

Hartford Healthcare

Hartford, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Parkinson's Foundation

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Augusta University

Augusta, Georgia, United States

Site Status