Using a randomized, placebo-controlled, double blind design, TOPAZ aims to determine whether treatment that improves BMD and reduces fractures in people with osteoporosis or hip fracture also reduces fracture risk in people with parkinsonism. The Trial Of Parkinson’s And Zoledronic acid (TOPAZ) was designed to overcome these barriers. It may be worse for older people with parkinsonism who are taking treatments for parkinsonism and other conditions 8. Additionally, compliance with oral treatments for osteoporosis is notably poor. Second, the conventional approach to assessment with BMD testing and medical visits for interpretation, prescription of osteoporosis treatment, and follow-up to assess response to treatment is not familiar to neurologists and can be burdensome for people with parkinsonism. First, there is no evidence that treatments reduce the fracture risk of people with parkinsonism whose increased risk may be due to multiple falls. There are several barriers to treatment of people with parkinsonism 7. Bisphosphonate therapy has been shown to reduce fracture risk in older women who have osteoporosis defined as a low bone mineral density (BMD), with less conclusive but suggestive evidence in men, and might be useful for fracture prevention in parkinsonism 5, 6.Īnecdotally, only a very small proportion of people with parkinsonism receive treatment to reduce fracture risk. For the vast majority of people with parkinsonism who are age 65 or older, the risk of fracture may be sufficient to warrant treatment with medications. For the purpose of this manuscript, we will refer to the group of disorders including PD and other neurodegenerative parkinsonisms as “parkinsonism”. Patients with other forms of neurodegenerative parkinsonism, such as progressive supranuclear palsy and multiple system atrophy, have similar risk of falls and fractures, and similar barriers to treatment 3, 4. The consequences of fractures – sustained disability and death – are also likely to be much greater for people with PD 2. The relative risk was somewhat greater for men than women and was not confined to those with advanced disease. A recent systematic review and meta-analysis found that people with PD, based on data from health systems and self-report, have a 2.35-fold increased risk of hip and 1.8-fold increased risk of all fractures besides vertebral fractures 1 (Fig. People with Parkinson’s disease (PD) have a high risk of fracture that may be due, in large part, to their high risk of multiple falls and impaired reflexes to protect against injury during a fall. Home-based clinical research may provide an efficient, convenient, less expensive method that opens participation in clinical trials to almost anyone with parkinsonism. 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. Participants receive information from multiple sources, including specialty practices, support groups and websites. The feasibility of TOPAZ is enhanced by its design as a U.S.- wide home-based trial without geographical limits. 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 Trial of Parkinson’s And Zoledronic acid (TOPAZ, ) 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.
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