This randomized clinical trial is designed to test the efficacy of the study drug: Zoledronic acid-5 mg, in Parkinson's disease (PD) subjects.
Zoledronic acid-5 mg (ZA) is an FDA approved therapy for men and postmenospausal women for the treatment and prevention of osteoporosis. This trial will also address barriers to treatment of subjects with PD by providing rigorous evidence about whether ZA reduces fracture risk in subjects with PD, simplifying treatment by giving ZA at home without extra medical visits and bone mineral density (BMD) testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how home based fracture prevention can reach older PD subjects who would not otherwise receive treatment to reduce their high risk of fractures.
This study is a randomized (1:1) placebo-controlled trial of a single infusion of ZA- 5 mg for the prevention of fractures in men and women aged 65 years and older with PD willing and able to continue in follow up for up to 5 years. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. Participants will be randomized to receive a single intravenous infusion of either ZA-5mg or placebo, infused over 45 minutes.
This trial is funded by the National Institute of Aging.