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Trial of Parkinson's And Zoledronic Acid (TOPAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924414
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of California, San Francisco
Duke University
University of Pittsburgh
Parkinson's Foundation
Information provided by (Responsible Party):
California Pacific Medical Center Research Institute

Brief Summary:
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 65 years and older with Parkinson's Disease with 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 Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj Other: Placebo Phase 4

Detailed Description:

This randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's Disease (PD) patients. This trial will also address barriers to treatment of patients with PD by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD, 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. (REFS 9-11) 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 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 will be scheduled for a Telemedicine assessment to further confirm the PD diagnosis, unless they have been referred directly from a participating neurologist. If confirmed, the participant will be mailed a supply of calcium 500 mg and vitamin D3 800-1000 IU and instructed to take one calcium tablet and 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.

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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 65 years and older with Parkinson's Disease 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women age 65 years or older
  • Current PD diagnosis with symptoms severity at Hoehn & Yahr (H&Y) stage 1-4 based on an expert assessment (movement disorders neurologist report or telemedicine evaluation)
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924414


Contacts
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Contact: Dana R Kriesel, MPH, MS (415) 476-6128 dkriesel@sfcc-cpmc.net
Contact: Christopher P Schambach, BA (415) 476-6129 cschambach@sfcc-cpmc.net

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
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Principal Investigator: Steve Cummings, MD CPMC Research Institute

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Responsible Party: California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT03924414    
Other Study ID Numbers: 20180456
1R01AG059417-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by California Pacific Medical Center Research Institute:
Parkinson Disease
Parkinson's Disease
Osteoporosis
Zoledronic acid
Neurology
Bone
Fracture
Additional relevant MeSH terms:
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Osteoporosis
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs