2650 Participants Needed

Zoledronic Acid for Parkinson's Disease

(TOPAZ Trial)

Recruiting at 75 trial locations
DR
CP
MS
Overseen ByMustafa Siddiqui, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: California Pacific Medical Center Research Institute
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but 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

How does the drug Zoledronic Acid differ from other treatments for Parkinson's disease?

Zoledronic Acid is unique for Parkinson's disease as it is primarily used for bone-related conditions like osteoporosis and not typically associated with neurological treatments. This makes its use in Parkinson's disease novel, as it may offer a different mechanism of action compared to traditional dopaminergic therapies.514161718

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
eConsent, screening questionnaire, baseline questionnaire, Telemedicine assessment, Nurse Home Visit

Treatment

Participants receive a single intravenous infusion of Zoledronic acid (5 mg) or placebo

1 day
1 Nurse Home Visit for drug administration

Follow-up

Participants are monitored for fractures and mortality every 4 months

2 years
Contact every 4 months

Long-term follow-up

Participants are monitored for clinical and hip fractures

5 years

Treatment Details

Interventions

  • Zoledronic Acid
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 European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Zometa for:
  • Prevention of skeletal events in patients with bone metastases from solid tumors
  • Treatment of tumor-induced hypercalcemia
🇺🇸
Approved in United States as Reclast for:
  • Treatment and prevention of osteoporosis in postmenopausal women
  • Treatment and prevention of glucocorticoid-induced osteoporosis
  • Treatment of Paget's disease of bone
🇨🇦
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

Who Is Running the Clinical Trial?

California Pacific Medical Center Research Institute

Lead Sponsor

Trials
44
Recruited
10,600+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Parkinson's Foundation

Collaborator

Trials
13
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.
[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.
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.
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]

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]
13.United Statespubmed.ncbi.nlm.nih.gov
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]
New medical and surgical treatments for Parkinson's disease. [2019]
17.United Statespubmed.ncbi.nlm.nih.gov
Spheramine for treatment of Parkinson's disease. [2021]
Targets and Mechanisms in Prevention of Parkinson's Disease through Immunomodulatory Treatments. [2017]