Zoledronic Acid for Parkinson's Disease
(TOPAZ Trial)
Trial Summary
What is the purpose of this trial?
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 2650 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used bisphosphonate drugs in the last 12 months or other osteoporosis treatments in the last 6 months.
What data supports the idea that Zoledronic Acid for Parkinson's Disease is an effective drug?
The available research does not provide any data supporting the effectiveness of Zoledronic Acid for treating Parkinson's Disease. The studies focus on other treatments and conditions related to Parkinson's, such as surgical interventions and joint replacements, but do not mention Zoledronic Acid as a treatment for Parkinson's Disease.12345
What safety data exists for Zoledronic Acid in treating Parkinson's Disease?
The provided research does not contain specific safety data for Zoledronic Acid (also known as Zometa or Reclast) in the treatment of Parkinson's Disease. The studies focus on other drugs like istradefylline, safinamide, and zonisamide for Parkinson's Disease, but none mention Zoledronic Acid. Therefore, no relevant safety data for Zoledronic Acid in this context is available from the provided research.678910
Is the drug Zoledronic Acid a promising treatment for Parkinson's Disease?
The information provided does not mention Zoledronic Acid as a treatment for Parkinson's Disease. Instead, it focuses on Zonisamide, which is shown to improve motor function in Parkinson's patients. Therefore, there is no evidence here to suggest that Zoledronic Acid is a promising treatment for Parkinson's Disease.1112131415
Eligibility Criteria
This trial is for men and women aged 60 or older with Parkinson's disease or parkinsonism, who can follow the study for at least 2 years. They must be able to consent and have a neurologist-confirmed diagnosis. People using bisphosphonates in the last year, those with recent or planned dental procedures, on osteoporosis treatments within 6 months, undergoing dialysis, non-ambulatory individuals, or with certain other diseases are excluded.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Zoledronic Acid (Bisphosphonate)
Zoledronic Acid is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of skeletal events in patients with bone metastases from solid tumors
- Treatment of tumor-induced hypercalcemia
- Treatment and prevention of osteoporosis in postmenopausal women
- Treatment and prevention of glucocorticoid-induced osteoporosis
- Treatment of Paget's disease of bone
- Prevention of skeletal events in patients with bone metastases from solid tumors
- Treatment of tumor-induced hypercalcemia
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone metastases from solid tumors
- Treatment of tumor-induced hypercalcemia
- Treatment of osteoporosis