Dr. Cummings leading a national study to test whether a simple, home-based approach may prevent fractures

Improving Care for Patients with Parkinson’s Disease
Researchers at Sutter Health’s San Francisco Coordinating Center to lead a national study to test whether a simple, home-based approach may prevent fractures

Older patients with Parkinson’s disease often suffer from a very high risk of falls, and may experience disabling fractures. Research has not shown whether drug treatments for the prevention of osteoporosis (such as zoledronic acid) could also prevent fractures in such affected individuals.

Researchers at the San Francisco Coordinating Center (SFCC) designed the “Trial of Parkinson’s and Zoledronic Acid”(TOPAZ) study to answer that question.  They lead a nationwide team including neurologists and bone disease experts from UC San Francisco (UCSF), the Parkinson’s Foundation, Duke University, and others in a trial to test the effectiveness of zoledronic acid, a medication whose benefits for bone last  at least two years after one intravenous treatment.  

“There are few treatments for Parkinson’s disease, but TOPAZ could show how a simple treatment given at home could prevent one of the most important causes of disability and death in these patients,” said Steve Cummings, M.D., Director of SFCC and a lead investigator of TOPAZ.  Dr. Cummings also noted that TOPAZ is the first of study of its kind nationwide.

“Fractures can result in a loss of independence, so it’s important to find ways to prevent them, particularly in this group of patients,” said Parkinson’s disease expert, Caroline Tanner, M.D., Ph.D., Professor of Neurology at UCSF and a lead investigator of TOPAZ. “We hope this study will provide us with some answers.”

“Patients with Parkinson’s disease have difficulty traveling to clinics for care. Our goal is to test if we can bring the evaluation and treatment to their home making it easier for them to reduce their risk of disabling fractures,” said Kenneth W. Lyles, MD, Senior Fellow in the Center for the Study of Aging and Human Development at Duke University, TOPAZ lead investigator at Duke, and world expert on zoledronic acid. 

The TOPAZ study seeks to enroll 3,500 patients with Parkinson’s disease who are 65 years or older. 

Neurologists who are specialists in Parkinson’s disease may conduct a video interview with the patient to confirm the diagnosis.  A study nurse will check patients to confirm that treatment with zoledronic acid would be safe, and once confirmed, will then give zoledronic acid or placebo intravenously.  Patients will be contacted every four months for at least two years about whether they have had a fracture.  

The five-year, $30 million study is sponsored by the National Institute on Aging, part of the U.S. National Institute of Health.  

Nearly 800,000 Americans age 65 or older have Parkinson’s disease—a brain illness that causes slow loss of control of movements, walking and balance, increased risk of falling, and decreased cognitive functions. There is no cure for Parkinson’s disease, but TOPAZ could show that one treatment could prevent a disabling consequence of the illness.