Trial of Parkinson’s And Zoledronic Acid

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Brief Title

Trial of Parkinson's And Zoledronic Acid

Official Title

TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease

Brief Summary

      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 3500 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.
    

Detailed Description

      This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in
      Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to
      treatment of patients with PD and parkinsonism by providing rigorous evidence about whether
      ZA reduces fracture risk in patients with PD and parkinsonism, simplifying treatment by
      giving ZA at home without extra medical visits and BMD testing, and overcoming poor
      persistence with oral therapies because one infusion may prevent bone loss for at least 2
      years. The outcome of this trial will demonstrate how a home-based fracture prevention can
      reach older PD patients who would not otherwise receive treatment to reduce their high risk
      of fractures.

      Patients with PD will be recruited throughout the US by participating neurologists and health
      networks as well as the Parkinson's Foundation. Patients may also self-refer to the study.
      Interested patients can access study information on a study website
      (topaz.eurekaplatform.org) as well as through the Parkinson's Foundation Helpline. Patients
      who wish to enroll will be directed to an interactive electronic consent (eConsent).
      Following eConsent, participants complete a screening questionnaire (to confirm eligibility),
      followed by a baseline questionnaire. If a participant is determined to be eligible following
      these steps, they may be scheduled for a Telemedicine assessment to further confirm the PD or
      parkinsonism diagnosis, unless they have been referred directly from a participating
      neurologist. If confirmed, the participant will be mailed a supply of vitamin D3 800-1000 IU
      and instructed to take one vitamin D tablet every day for 2 months. Lastly, a Nurse Home
      Visit will be scheduled and conducted to confirm final eligibility, randomization, and
      administration of the study drug, if appropriate. Participants who are randomized will be
      contacted every 4 months for at least 2 years to determine if they have had any fractures.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Number of Participants with Clinical Fractures

Secondary Outcome

 Number of Participants Hip Fractures

Condition

Parkinson Disease

Intervention

Zoledronic Acid 5Mg/Bag 100Ml Inj

Study Arms / Comparison Groups

 Zoledronic acid (ZA)
Description:  A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3500

Start Date

November 15, 2019

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women age 60 years or older

          -  Current Parkinson's Disease diagnosis or neurodegenerative parkinsonism diagnosis
             (including progressive supranuclear palsy, multiple system atrophy, cortical basal
             degeneration, vascular parkinsonism, dementia with Lewy bodies or another form of
             neurodegenerative parkinsonism) based on an expert assessment (neurologist diagnosis
             via medical records confirmation or Telemedicine Screening Assessment)

          -  Willing and able to continue in follow-up for at least 2 years

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  History of hip fracture

          -  Any use of a bisphosphonate drug within the last 12 months

          -  Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last
             6 months

          -  Tooth extraction or invasive dental procedures within the past 30 days or
             planned/scheduled extraction/procedure in the next 12 months

          -  Non-ambulatory, i.e., unable to walk without assistance of another person.

          -  Undergoing kidney dialysis

          -  A diagnosis of multiple myeloma or Paget's disease

          -  Unable to speak or read English sufficiently to complete informed consent

          -  Any other criteria, which would make the patient unsuitable to participate in this
             study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol
             addiction)
      

Gender

All

Ages

60 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Steve Cummings, MD, (877) 378-6729, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03924414

Organization ID

20180456

Secondary IDs

1R01AG059417-01A1

Responsible Party

Sponsor

Study Sponsor

California Pacific Medical Center Research Institute

Collaborators

 National Institute on Aging (NIA)

Study Sponsor

Steve Cummings, MD, Principal Investigator, CPMC Research Institute


Verification Date

January 2021