Summary

for people ages 65 years and up (full criteria)
healthy people welcome
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Parkinson Disease Osteoporosis Parkinson's Disease Zoledronic acid Neurology Bone Fracture Zoledronic Acid 5Mg/Bag 100Ml Inj Zoledronic acid (ZA)

Eligibility

You can join if…

Open to people ages 65 years and up

  • 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

You CAN'T join if...

  • 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)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
California Pacific Medical Center Research Institute
ID
NCT03924414
Phase
Phase 4
Study Type
Interventional
Last Updated