Trial of Parkinson's And Zoledronic Acid

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 3500 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: California Pacific Medical Center Research Institute
• Collaborators: Duke University; National Institute on Aging (NIA); Parkinson's Foundation; University of California, San Francisco; University of Pittsburgh
• Treatments: Zoledronic Acid

Criteria

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)