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

Year: 2021

Type: article

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.

Source: npj Parkinson s Disease

DOI: 10.1038/s41531-021-00162-1

Authors: 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

Institutions: San Francisco VA Medical Center, University of California, San Francisco, San Francisco VA Health Care System, California Pacific Medical Center, Massachusetts General Hospital, University of Rochester Medicine, University of Rochester, University of Cincinnati, University of California San Diego, University of Florida Health, University of Florida, Duke University, Duke Medical Center, University of Alabama at Birmingham, University of Pittsburgh, Parkinson's Foundation, Durham VA Medical Center

Language: English

Topic: Bone health and osteoporosis research

Subfield: Orthopedics and Sports Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,990

Funders: U.S. Department of Defense, U.S. Department of Health and Human Services, U.S. Department of Commerce, Michael J. Fox Foundation for Parkinson's Research, Amgen, Alzheimer's Drug Discovery Foundation, Eli Lilly and Company, Pfizer, GlaxoSmithKline, Sanofi, Yale University, Biogen, American Parkinson Disease Association, Office of Research and Development, AbbVie, Michigan State University, University of Alabama at Birmingham, Boston Scientific Corporation, Sunovion, University of Alabama, Target ALS, Parkinson's Foundation, ACADIA Pharmaceuticals, Acorda Therapeutics, Neurocrine Biosciences, Denali Therapeutics, Voyager Therapeutics, Farmer Family Foundation, University of Cambridge, H. Lundbeck A/S, National Institutes of Health, Health Resources and Services Administration, College of Engineering, Michigan State University, University of California, San Diego, Parkinsonfonden, University of California, Irvine, Avid Radiopharmaceuticals, Spark Therapeutics, National Institute on Aging, National Institute of Neurological Disorders and Stroke, Agency for Toxic Substances and Disease Registry, UCB Pharma

OpenAlex ID: W3135855865