Trial of Parkinson's And Zoledronic Acid

NCT03924414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2650

Last updated 2025-03-04

No results posted yet for this study

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

Interventions

DRUG

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.

OTHER

Placebo

Normal Saline 100 ml (placebo) IV infusion

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • University of California, San Francisco

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • Parkinson's Foundation

    collaborator OTHER
  • California Pacific Medical Center Research Institute

    lead OTHER

Principal Investigators

  • Steve Cummings, MD · CPMC Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924414 on ClinicalTrials.gov