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.
Status | Finished |
---|---|
Effective start/end date | 4/29/20 → 6/1/24 |
Funding
- Parkinsons Foundation: $2.00
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