Study Details
Trial of Parkinson's and Zoledronic Acid
(IRB#: IRB_00170689)
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.
- All genders
- Volunteers with special conditions
- From Home
- Unpaid
Who can participate?
Gender: All genders
Age:
Volunteers: Volunteers with special conditions
Location: From Home
Inclusion Criteria
- Men and women age 60 years or older
- Current Parkinsons 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)
- Not confined to bed or wheel chair
- Willing and able to continue in follow-up for up to 5 years
- Willing and able to provide informed consent or consent provided by a patients health care agent.
Exclusion Criteria
- History of hip fracture
- Any use of a bisphosphonate drug within the last 12 months
- Any use of the following osteoporosis drugs within the last 6 months: Parathyroid hormones or monoclonal antibodies used for the treatment of osteoporosis
- Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months
- Undergoing kidney dialysis
Will I be paid for my time?
No
IRB#: IRB_00170689
PI: Paolo Moretti
Department: NEUROLOGY
Approval Date: 2024-05-03 13:43:00
Study Categories: Brain Health Studies
Specialties: Neurology