Trial of Parkinson's And Zoledronic Acid
NCT03924414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2650
Last updated 2025-03-04
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
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 - 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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