npj Parkinson's Disease (Mar 2021)

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

  • 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

DOI
https://doi.org/10.1038/s41531-021-00162-1
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 6

Abstract

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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.