A Study to Evaluate Zoledronic Acid for Fracture Prevention in Parkinson's Disease Patients

Overview

About this study

The purpose of this study is to evaluate the use of a single infusion of zoledronic acid-5 mg (ZA) vs. placebo for the prevention of fractures in men and women aged 65 years and older with Parkinson's Disease with 2 years of follow-up.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Drake, M.D., Ph.D.

Open for enrollment

Contact information:

Vishakantha Murthy Ph.D., M.B.A., CCRP

(919) 265-9986

Murthy.Vishakantha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20509162

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