TOPAZ: Trial of Parkinson’s And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson’s Disease

Sponsor:

Brief 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 65 years and
older with Parkinson’s disease and parkinsonism with 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.

Criteria

Inclusion Criteria:

– Men and women age 65 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)

Locations

Loma Linda University, Loma Linda, California, United States, 92350
Valley Parkinson Clinic, Los Gatos, California, United States, 95032
UC Davis Medical Center, Sacramento, California, United States, 95817
University of California, San Francisco, San Francisco, California, United States, 94115