Clinical Trial TitleTrial of Parkinson's & Zoledronic Acid (TOPAZ)
National Clinical Trial Number:NCT03924414
Clinical Trial Protocol Description:
This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism.
The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and 60 years of age or older.
- Have 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).
- Are willing and able to continue in follow-up for at least 2 years.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of hip fracture.
- Have 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.
- Have had tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months.
- Are non-ambulatory, i.e., unable to walk without assistance of another person.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.