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Trial of Parkinson's And Zoledronic Acid (TOPAZ)

Primary Purpose

Parkinson Disease, Osteoporosis, Parkinsonism

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid 5Mg/Bag 100Ml Inj
Placebo
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Parkinson's Disease, Osteoporosis, Zoledronic acid, Neurology, Bone, Fracture, Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia with Lewy Bodies

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo ClinicRecruiting
  • Washington Regional Medical CenterRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • Sutter HealthRecruiting
  • Parkinson's and Movement Disorder InstituteRecruiting
  • University of California, IrvineRecruiting
  • Loma Linda University
  • University of California, Los AngelesRecruiting
  • Valley Parkinson ClinicRecruiting
  • Parkinson's Disease and Movement Disorder Center of Silicon ValleyRecruiting
  • University of California, RiversideRecruiting
  • Sutter HealthRecruiting
  • University of California, DavisRecruiting
  • University of California, San FranciscoRecruiting
  • University of Colorado, DenverRecruiting
  • University of ConnecticutRecruiting
  • University of ConnecticutRecruiting
  • University of FloridaRecruiting
  • Mayo ClinicRecruiting
  • Parkinson's FoundationRecruiting
  • University of MiamiRecruiting
  • Emory University School of MedicineRecruiting
  • Augusta UniversityRecruiting
  • Queens Medical CenterRecruiting
  • Northwestern MedicineRecruiting
  • Cook County Health & Hospitals SystemRecruiting
  • Rush UniversityRecruiting
  • University of ChicagoRecruiting
  • Edward Hines, Jr. VA HospitalRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of KentuckyRecruiting
  • Ochsner Health SystemRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Boston UniversityRecruiting
  • Michigan State UniversityRecruiting
  • Quest Research InstituteRecruiting
  • Mayo ClinicRecruiting
  • Albany Medical CollegeRecruiting
  • Stony Brook University Medical CenterRecruiting
  • Northwell HealthRecruiting
  • Northwell HealthRecruiting
  • Northwell HealthRecruiting
  • New York University Langone HealthRecruiting
  • Weill Cornell MedicineRecruiting
  • University of RochesterRecruiting
  • Duke UniversityRecruiting
  • Wake Forest UniversityRecruiting
  • University of CincinnatiRecruiting
  • Case Western Reserve University, UH ClevelandRecruiting
  • The Ohio State UniversityRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of PittsburghRecruiting
  • Lankenau Medical CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • Veracity Neuroscience LLCRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • Houston Methodist Neurological Institute
  • University of Texas Health Houston Medical CenterRecruiting
  • University of Texas Health Science Center at San AntonioRecruiting
  • Intermountain Medical CenterRecruiting
  • University of VermontRecruiting
  • Booth Gardner Parkinson's Care Center at EvergreenHealthRecruiting
  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zoledronic acid (ZA)

Placebo

Arm Description

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

A single intravenous infusion of placebo infused over 45 minutes

Outcomes

Primary Outcome Measures

Number of Participants with Clinical Fractures
All clinical fractures
Number of Participants with Clinical Fractures
All clinical fractures

Secondary Outcome Measures

Number of Participants Hip Fractures
Hip fractures
Number of Participants Hip Fractures
Hip fractures
Mortality
All-cause mortality
Mortality
All-cause mortality

Full Information

First Posted
April 2, 2019
Last Updated
July 24, 2023
Sponsor
California Pacific Medical Center Research Institute
Collaborators
National Institute on Aging (NIA), University of California, San Francisco, Duke University, University of Pittsburgh, Parkinson's Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03924414
Brief Title
Trial of Parkinson's And Zoledronic Acid
Acronym
TOPAZ
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
California Pacific Medical Center Research Institute
Collaborators
National Institute on Aging (NIA), University of California, San Francisco, Duke University, University of Pittsburgh, Parkinson's Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Osteoporosis, Parkinsonism, Parkinson's Disease and Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia With Lewy Bodies
Keywords
Parkinson Disease, Parkinson's Disease, Osteoporosis, Zoledronic acid, Neurology, Bone, Fracture, Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia with Lewy Bodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid (ZA)
Arm Type
Active Comparator
Arm Description
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single intravenous infusion of placebo infused over 45 minutes
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid 5Mg/Bag 100Ml Inj
Other Intervention Name(s)
Reclast
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal Saline 100 ml (placebo) IV infusion
Primary Outcome Measure Information:
Title
Number of Participants with Clinical Fractures
Description
All clinical fractures
Time Frame
2 years
Title
Number of Participants with Clinical Fractures
Description
All clinical fractures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Participants Hip Fractures
Description
Hip fractures
Time Frame
2 years
Title
Number of Participants Hip Fractures
Description
Hip fractures
Time Frame
5 years
Title
Mortality
Description
All-cause mortality
Time Frame
2 years
Title
Mortality
Description
All-cause mortality
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana R Kriesel, MPH, MS
Phone
(877) 378-6729
Email
robertdc@sutterhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher P Schambach, MA
Phone
(877) 378-6729
Email
schambcp@sutterhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Cummings, MD
Organizational Affiliation
CPMC Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Washington Regional Medical Center
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Sutter Health
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Parkinson's and Movement Disorder Institute
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Valley Parkinson Clinic
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Neng Huang, MD
First Name & Middle Initial & Last Name & Degree
Peter Lin, MD
Facility Name
Parkinson's Disease and Movement Disorder Center of Silicon Valley
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Salima Brillman, MD
Facility Name
University of California, Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Sutter Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Caroline Tanner, MD
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Parkinson's Foundation
City
Miami
State/Province
Florida
ZIP/Postal Code
33131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Queens Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Cook County Health & Hospitals System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research University
Phone
800-473-4636
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Stony Brook University Medical Center
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Northwell Health
City
Glen Cove
State/Province
New York
ZIP/Postal Code
11542
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Kenneth W Lyles, MD
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Siddiqui, MD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Case Western Reserve University, UH Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coodinator
Phone
800-473-4636
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Robyn E Massa, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Veracity Neuroscience LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Mark LeDoux, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Houston Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Texas Health Houston Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
Facility Name
Booth Gardner Parkinson's Care Center at EvergreenHealth
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reseaerch Coordinator
Phone
800-473-4636
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
800-473-4636
First Name & Middle Initial & Last Name & Degree
Kathleen Shannon, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33649343
Citation
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.
Results Reference
derived

Learn more about this trial

Trial of Parkinson's And Zoledronic Acid

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