Trial Of Parkinson's And Zoledronic Acid (TOPAZ)

Grants and Contracts Details

Description

Randomized, double-blind, placebo-controlled trial of a single infusion of zoledronic acid (ZA) 5mg, given in the home, to prevent fractures in people with Parkinson’s disease. The primary aim of the study is to evaluate the efficacy of zoledronic acid (ZA) to reduce the risk of clinical fractures in Parkinson’s disease The secondary aims are: • To evaluate the efficacy of ZA to reduce the risk of hip fractures in PD • To evaluate the efficacy of ZA to reduce all-cause mortality in PD Participants will be recruited in two ways: Method 1 STEP 1: Participant is referred by a PSG or PF CoE movement disorder specialist (MDS) and given a card with a personalized referral code. STEP 2: Participant goes online to enter code and complete informed consent. STEP 3: A secure email is sent to the referring MDS. The MDS then confirms eligibility based on electronic medical review. STEP 4: A nurse home visit is scheduled to confirm final eligibility, randomization, and administration of study drug, if appropriate. Note: No telemedicine visit is needed for participants recruited through this method. Method 2 STEP 1: Participant is identified through: 1. An algorithm designed to identify people with PD through review of medical records in health systems / Clinical Data Research Networks (CDRNs) 2. Patient listings from the PF 3. Self-referral through public registries STEP 2: Participants will either be contacted by the PF, or can go online and review consent materials. Information about any treating neurologist will be obtained. STEP 3: Participant provides informed consent. STEP 4: If the participant does not have a PSG or PF COE MDS, a telemedicine visit will be scheduled for screening and confirmation of diagnosis. STEP 5: A nurse home visit is scheduled to confirm final eligibility, randomization, and administration of study drug, if appropriate.
StatusFinished
Effective start/end date4/29/206/1/24

Funding

  • Parkinsons Foundation: $2.00

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