~224 spots leftby Oct 2025

Zoledronic Acid for Parkinson's Disease

(TOPAZ Trial)

Recruiting in Palo Alto (17 mi)
+75 other locations
SC
Overseen bySteve Cummings, MD
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

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+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+
Suresh Gunasekaran profile image

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day profile image

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+
Mary E. Klotman profile image

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath profile image

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+
David Apelian profile image

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone profile image

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

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]