The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism

Abstract: 

The Trial of Parkinson's And Zoledronic acid (TOPAZ, https://clinicaltrials.gov/ct2/show/NCT03924414 ) is a unique collaboration between experts in movement disorders and osteoporosis to test the efficacy of zoledronic acid, an FDA-approved parenteral treatment for osteoporosis, for fracture prevention in people with neurodegenerative parkinsonism. Aiming to enroll 3,500 participants age 65 years or older, TOPAZ is one of the largest randomized, placebo-controlled clinical trials ever attempted in parkinsonism. The feasibility of TOPAZ is enhanced by its design as a U.S.- wide home-based trial without geographical limits. Participants receive information from multiple sources, including specialty practices, support groups and websites. Conducting TOPAZ in participants' homes takes advantage of online consent technology, the capacity to confirm diagnosis using telemedicine and the availability of research nursing to provide screening and parenteral therapy in homes. Home-based clinical research may provide an efficient, convenient, less expensive method that opens participation in clinical trials to almost anyone with parkinsonism.

Author: 
Caroline M Tanner
Steven R Cummings
Michael A Schwarzschild
Ethan G Brown
E Ray Dorsey
Alberto J Espay
Nicholas B Galifianakis
Samuel M Goldman
Irene Litvan
Nijee Luthra
Nikolaus R McFarland
Kyle T Mitchell
David G Standaert
Douglas C Bauer
Susan L Greenspan
James C Beck
Kenneth W Lyles
Publication date: 
March 1, 2021
Publication type: 
Journal Articles
Citation: 
Tanner CM, Cummings SR, Schwarzschild MA, Brown EG, Dorsey ER, Espay AJ, Galifianakis NB, Goldman SM, Litvan I, Luthra N, McFarland NR, Mitchell KT, Standaert DG, Bauer DC, Greenspan SL, Beck JC, Lyles KW. The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism. NPJ Parkinsons Dis. 2021 Mar 1;7(1):16. doi: 10.1038/s41531-021-00162-1. PMID: 33649343; PMCID: PMC7921548.