Zoledronic Acid for Parkinson's Disease
(TOPAZ Trial)
Recruiting in Palo Alto (17 mi)
+75 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: California Pacific Medical Center Research Institute
Prior Safety Data
Approved in 4 Jurisdictions
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
Research Team
SC
Steve Cummings, MD
Principal Investigator
CPMC Research Institute
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
I am 60 years old or older.
I have been diagnosed with Parkinson's Disease or parkinsonism by a neurologist.
Willing and able to continue in follow-up for at least 2 years
See 3 more
Exclusion Criteria
I need someone's help to walk.
I haven't had nor plan to have any tooth extractions or major dental work soon.
The study staff decides that you are not suitable for the study, for example, if you have an uncontrolled drug or alcohol addiction.
See 6 more
Treatment Details
Interventions
- Zoledronic Acid (Bisphosphonate)
Trial OverviewThe study tests if a single infusion of Zoledronic Acid (ZA) can prevent fractures compared to a placebo in patients with Parkinson's-related conditions. It's randomized and blinded—meaning neither participants nor researchers know who gets ZA or placebo—and involves over three thousand participants across the U.S.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Zoledronic acid (ZA)Active Control1 Intervention
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Group II: PlaceboPlacebo Group1 Intervention
A single intravenous infusion of placebo infused over 45 minutes
Zoledronic Acid is already approved in Canada, Japan for the following indications:
Approved in Canada as Zometa for:
- Prevention of skeletal events in patients with bone metastases from solid tumors
- Treatment of tumor-induced hypercalcemia
- Treatment of osteoporosis in postmenopausal women
Approved in Japan as Zometa for:
- Treatment of bone metastases from solid tumors
- Treatment of tumor-induced hypercalcemia
- Treatment of osteoporosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
St. Mary's Medical CenterGrand Junction, CO
Hartford HealthcareHartford, CT
Morehouse School of MedicineAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
California Pacific Medical Center Research Institute
Lead Sponsor
Trials
44
Patients Recruited
10,600+
National Institute on Aging (NIA)
Collaborator
Trials
1841
Patients Recruited
28,150,000+
University of California, San Francisco
Collaborator
Trials
2636
Patients Recruited
19,080,000+
Duke University
Collaborator
Trials
2495
Patients Recruited
5,912,000+
University of Pittsburgh
Collaborator
Trials
1820
Patients Recruited
16,360,000+
Parkinson's Foundation
Collaborator
Trials
13
Patients Recruited
1,030,000+
Findings from Research
In a study of 41 patients with Parkinson's syndrome who underwent hip fracture surgery, those treated with endoprosthesis showed significantly better walking recovery compared to those treated with internal fixation, with 62.5% of endoprosthesis patients able to walk independently after rehabilitation.
Overall, Parkinson's disease negatively impacts walking recovery after hip fractures, as 21.9% of patients were unable to walk at the end of rehabilitation, highlighting the challenges faced by this population.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Gait in patients with Parkinson's disease after surgically treated hip fracture].Gialanella, B.[2014]
Parkinson's disease patients face higher risks of falls and osteoporosis, complicating their treatment for hip fractures, particularly regarding surgical approaches and post-operative care.
There is uncertainty about whether Parkinson's patients have a worse prognosis after hip fractures compared to age-matched individuals, indicating a need for more research to clarify their outcomes and improve care strategies.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Parkinson's disease patients who fracture their neck of femur: a review of outcome data.Clubb, VJ., Clubb, SE., Buckley, S.[2008]
In a case study of a 75-year-old woman with Parkinson's disease and psychosis, intramuscular botulinum toxin injections were successfully used to aid in the immobilization of her fractured arm after surgery, helping to protect the surgical site during recovery.
Three months post-surgery, the patient showed signs of successful fracture healing, indicating that botulinum toxin could be a safe and effective option for patients who struggle with immobilization due to psychiatric conditions.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Botulinum Toxin as an Adjunctive Therapy for Immobilization of a Distal Humerus Fracture in Parkinson's Disease-Associated Psychosis: A Case Report.Lapow, J., Hirth, J., Agarwalla, A., et al.[2023]
In a study of 10 patients with Parkinson's disease undergoing unicompartmental knee arthroplasty (UKA), there were no perioperative complications, and patients experienced significant improvements in knee pain and physical function as measured by the Knee Society Scores and SF-36 Physical Component Scores.
Despite the improvements in pain and some functional scores, the surgery did not lead to better range of motion or overall knee function, as many patients still had unchanged flexion contractures and only a few were able to ambulate independently at follow-up.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Unicompartmental knee arthroplasty in patients with Parkinson's disease.Goh, GS., Zeng, GJ., Thever, Y., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Neurosurgical stereotactic treatment in Parkinson's disease].Schuurman, PR., Speelman, JD., de Bie, RM., et al.[2017]
A review of 402 drug-related adverse events linked to movement disorders revealed that calcium-entry blockers (31%) and benzamides (27%) were the most commonly implicated drugs.
The study found that serious adverse events occurred in nearly 80% of cases, predominantly affecting females and individuals aged 11-30 and 60-80 years, highlighting the need for caution when prescribing these medications.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Drug-induced extrapyramidal disorders].Horga, JF., Navarro, M., Peiró, V., et al.[2022]
Istradefylline, when used alongside levodopa, significantly reduces the time patients with Parkinson's Disease spend in the OFF state and improves motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
The study found that istradefylline is safe, with no significant differences in adverse events compared to placebo, although it was associated with a higher risk of dyskinesia.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Istradefylline, an adenosine A₂A receptor antagonist, for patients with Parkinson's Disease: a meta-analysis.Chen, W., Wang, H., Wei, H., et al.[2014]
In a study of 511 Spanish patients with Parkinson's Disease, safinamide demonstrated a favorable safety profile and led to significant improvements in motor function, with 57.4% of patients showing clinically meaningful benefits when used as an add-on to levodopa.
Motor complications decreased from 83.2% to 63.3% over the study period, indicating safinamide's efficacy in managing symptoms, although caution is advised for patients with cognitive impairment due to a slightly higher frequency of adverse events.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: post-hoc analysis of the Spanish study population.Kulisevsky, J., Esquivel, A., Freire-Álvarez, E., et al.[2023]
Zonisamide significantly improves motor function in patients with Parkinson's disease (PD) and Dementia with Lewy bodies (DLB), as evidenced by a reduction in the UPDRS III total score in a study of 1749 patients.
While zonisamide shows promise as a treatment option, it may increase the risk of adverse effects such as contusions and reduced appetite in DLB patients, and somnolence in PD patients, indicating the need for further safety evaluations.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Zonisamide's Efficacy and Safety on Parkinson's Disease and Dementia with Lewy Bodies: A Meta-Analysis and Systematic Review.Kong, L., Xi, J., Jiang, Z., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A systematic review and meta-analysis of safety and efficacy of safinamide for motor fluctuations in patients with Parkinson's disease.Abdelalem Aziz Ahmed, M.[2020]
In two 12-week clinical trials involving adult patients with Parkinson's disease, zonisamide (25 mg once daily) significantly improved motor function compared to placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
Zonisamide was generally well tolerated, with no significant difference in the incidence of adverse events between the zonisamide and placebo groups, indicating a favorable safety profile as an adjunctive therapy with levodopa.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Zonisamide: in Parkinson's disease.Yang, LP., Perry, CM.[2021]
Zonisamide (ZNS) has been found to significantly improve motor function in advanced Parkinson's disease patients at a low dose of 25 mg per day, with effects lasting for at least one year, leading to its approval as an anti-parkinsonian agent in Japan in 2009.
The mechanism of ZNS's benefits includes increasing dopamine levels in the brain by enhancing the synthesis of dopamine and inhibiting monoamine oxidase activity, along with neuroprotective effects that may help in managing Parkinson's disease.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[The discovery of an antiparkinsonian drug, zonisamide].Murata, M.[2019]
Zonisamide enhances the effects of levodopa in treating motor symptoms of Parkinson's disease, but it also increases levodopa-induced abnormal involuntary movements, indicating a complex interaction between the two drugs.
The study suggests that zonisamide's antiparkinsonian effects are primarily due to its modulation of levodopa-dopamine metabolism in the striatum, rather than through direct dopaminergic pathways, as it did not affect key dopamine-related proteins in the brain.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Zonisamide Enhances Motor Effects of Levodopa, Not of Apomorphine, in a Rat Model of Parkinson's Disease.Nishijima, H., Miki, Y., Ueno, S., et al.[2020]
Current research is advancing in three main therapy categories for Parkinson's disease: symptomatic treatments, neuroprotective strategies, and neurorestorative approaches, with several promising therapies in clinical trials.
Gene therapy techniques, particularly those using viral vectors to deliver therapeutic genes into the brain, have shown modest benefits in early trials, including a method that encodes for glutamic acid decarboxylase, which may help improve symptoms.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Upcoming treatments in Parkinson's disease, including gene therapy.Rodnitzky, RL.[2012]
In a phase 3 trial involving 351 patients with dementia with Lewy bodies (DLB), zonisamide significantly improved motor function compared to placebo, with a notable reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) scores at 12 weeks.
Both 25 mg and 50 mg doses of zonisamide were found to be safe and well tolerated, with adverse events occurring in about 47% to 55% of patients, indicating a manageable safety profile.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of zonisamide on parkinsonism in patients with dementia with Lewy bodies: A phase 3 randomized clinical trial.Murata, M., Odawara, T., Hasegawa, K., et al.[2021]
References
[Gait in patients with Parkinson's disease after surgically treated hip fracture]. [2014]
Parkinson's disease patients who fracture their neck of femur: a review of outcome data. [2008]
Botulinum Toxin as an Adjunctive Therapy for Immobilization of a Distal Humerus Fracture in Parkinson's Disease-Associated Psychosis: A Case Report. [2023]
Unicompartmental knee arthroplasty in patients with Parkinson's disease. [2021]
[Neurosurgical stereotactic treatment in Parkinson's disease]. [2017]
[Drug-induced extrapyramidal disorders]. [2022]
Istradefylline, an adenosine A₂A receptor antagonist, for patients with Parkinson's Disease: a meta-analysis. [2014]
SYNAPSES. A European observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: post-hoc analysis of the Spanish study population. [2023]
Zonisamide's Efficacy and Safety on Parkinson's Disease and Dementia with Lewy Bodies: A Meta-Analysis and Systematic Review. [2022]
A systematic review and meta-analysis of safety and efficacy of safinamide for motor fluctuations in patients with Parkinson's disease. [2020]
Zonisamide: in Parkinson's disease. [2021]
[The discovery of an antiparkinsonian drug, zonisamide]. [2019]
Zonisamide Enhances Motor Effects of Levodopa, Not of Apomorphine, in a Rat Model of Parkinson's Disease. [2020]
Upcoming treatments in Parkinson's disease, including gene therapy. [2012]
Effect of zonisamide on parkinsonism in patients with dementia with Lewy bodies: A phase 3 randomized clinical trial. [2021]