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出境医 / 临床实验 / Trial of Parkinson's And Zoledronic Acid (TOPAZ)

Trial of Parkinson's And Zoledronic Acid (TOPAZ)

Study Description
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Osteoporosis Parkinsonism Parkinson's Disease and Parkinsonism Atypical Parkinsonism Progressive Supranuclear Palsy Multiple System Atrophy Vascular Parkinsonism Dementia With Lewy Bodies Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj Other: Placebo Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This 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 or parkinsonism with at least 2 years of follow-up.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Zoledronic acid (ZA)
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
 Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
Zoledronic acid 5mg/100 ml IV infusion: Zoledronic acid-5 mg (ZA) is an FDA approved therapy for men and postmenopausal women for the treatment and prevention of osteoporosis.
Other Name: Reclast
Placebo Comparator: Placebo
A single intravenous infusion of placebo infused over 45 minutes
 Other: Placebo
Normal Saline 100 ml (placebo) IV infusion
Outcome Measures
Primary Outcome Measures :
  1. Number of Participants with Clinical Fractures [ Time Frame: 2 years ]
    All clinical fractures


Secondary Outcome Measures :
  1. Number of Participants Hip Fractures [ Time Frame: 2 years ]
    Hip fractures

  2. Mortality [ Time Frame: 2 years ]
    All-cause mortality


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Dana R Kriesel, MPH, MS (877) 378-6729 robertdc@sutterhealth.org
Contact: Christopher P Schambach, MA (877) 378-6729 schambcp@sutterhealth.org

Locations
Show Show 32 study locations
Sponsors and Collaborators
California Pacific Medical Center Research Institute
National Institute on Aging (NIA)
University of California, San Francisco
Duke University
University of Pittsburgh
Parkinson's Foundation
Investigators
Layout table for investigator information
Principal Investigator: Steve Cummings, MD CPMC Research Institute
Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date February 1, 2021
Actual Study Start Date  ICMJE November 15, 2019
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019) 		Number of Participants with Clinical Fractures [ Time Frame: 2 years ]
All clinical fractures
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Number of Participants Hip Fractures [ Time Frame: 2 years ]
    Hip fractures
  • Mortality [ Time Frame: 2 years ]
    All-cause mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Parkinson's And Zoledronic Acid
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This 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 or parkinsonism with at least 2 years of follow-up.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Osteoporosis
  • Parkinsonism
  • Parkinson's Disease and Parkinsonism
  • Atypical Parkinsonism
  • Progressive Supranuclear Palsy
  • Multiple System Atrophy
  • Vascular Parkinsonism
  • Dementia With Lewy Bodies
Intervention  ICMJE
  • Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
    Zoledronic acid 5mg/100 ml IV infusion: Zoledronic acid-5 mg (ZA) is an FDA approved therapy for men and postmenopausal women for the treatment and prevention of osteoporosis.
    Other Name: Reclast
  • Other: Placebo
    Normal Saline 100 ml (placebo) IV infusion
Study Arms  ICMJE
  • Active Comparator: Zoledronic acid (ZA)
    A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
    Intervention: Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
  • Placebo Comparator: Placebo
    A single intravenous infusion of placebo infused over 45 minutes
    Intervention: Other: Placebo
Publications * Tanner CM, Cummings SR, Schwarzschild MA, Brown EG, Dorsey ER, Espay AJ, Galifianakis NB, Goldman SM, Litvan I, Luthra N, McFarland NR, Mitchell KT, Standaert DG, Bauer DC, Greenspan SL, Beck JC, Lyles KW. The TOPAZ study: a home-based trial of zoledronic acid to prevent fractures in neurodegenerative parkinsonism. NPJ Parkinsons Dis. 2021 Mar 1;7(1):16. doi: 10.1038/s41531-021-00162-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		3500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dana R Kriesel, MPH, MS (877) 378-6729 robertdc@sutterhealth.org
Contact: Christopher P Schambach, MA (877) 378-6729 schambcp@sutterhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03924414
Other Study ID Numbers  ICMJE 20180456
1R01AG059417-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • University of California, San Francisco
  • Duke University
  • University of Pittsburgh
  • Parkinson's Foundation
Investigators  ICMJE
Principal Investigator: Steve Cummings, MD CPMC Research Institute
PRS Account California Pacific Medical Center Research Institute
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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