Trial of Parkinson's And Zoledronic Acid (TOPAZ)
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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 |
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Recruitment Status :
Recruiting
First Posted : April 23, 2019
Last Update Posted : May 4, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease Osteoporosis Parkinsonism Parkinson's Disease and Parkinsonism Atypical Parkinsonism Progressive Supranuclear Palsy Multiple System Atrophy Vascular Parkinsonism Dementia With Lewy Bodies | Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj Other: Placebo | Phase 4 |
This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism, 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. 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 (topaz.eurekaplatform.org) 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 may be scheduled for a Telemedicine assessment to further confirm the PD or parkinsonism diagnosis, unless they have been referred directly from a participating neurologist. If confirmed, the participant will be mailed a supply of vitamin D3 800-1000 IU and instructed to take 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.
| 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 60 years and older with Parkinson's Disease or parkinsonism 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 |
| Actual Study Start Date : | November 15, 2019 |
| Estimated Primary Completion Date : | November 14, 2023 |
| Estimated Study Completion Date : | November 14, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Zoledronic acid (ZA)
A single intravenous infusion of Zoledronic acid (5 mg) infused over 45 minutes
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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 |
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Placebo Comparator: Placebo
A single intravenous infusion of placebo infused over 45 minutes
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Other: Placebo
Normal Saline 100 ml (placebo) IV infusion |
- Number of Participants with Clinical Fractures [ Time Frame: 2 years ]All clinical fractures
- Number of Participants Hip Fractures [ Time Frame: 2 years ]Hip fractures
- Mortality [ Time Frame: 2 years ]All-cause mortality
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.
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Men and women age 60 years or older
- Current Parkinson's Disease diagnosis or neurodegenerative parkinsonism diagnosis (including progressive supranuclear palsy, multiple system atrophy, cortical basal degeneration, vascular parkinsonism, dementia with Lewy bodies or another form of neurodegenerative parkinsonism) based on an expert assessment (neurologist diagnosis via medical records confirmation or Telemedicine Screening Assessment)
- 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)
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
| Contact: Dana R Kriesel, MPH, MS | (877) 378-6729 | robertdc@sutterhealth.org | |
| Contact: Christopher P Schambach, MA | (877) 378-6729 | schambcp@sutterhealth.org |
Show 55 study locations
| Principal Investigator: | Steve Cummings, MD | CPMC Research Institute |
| 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: | May 4, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Parkinson Disease Parkinson's Disease Osteoporosis Zoledronic acid Neurology Bone Fracture |
Parkinsonism Atypical Parkinsonism Progressive Supranuclear Palsy Multiple System Atrophy Vascular Parkinsonism Dementia with Lewy Bodies |
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Osteoporosis Parkinson Disease Dementia Multiple System Atrophy Shy-Drager Syndrome Supranuclear Palsy, Progressive Parkinsonian Disorders Lewy Body Disease Atrophy Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Pathological Conditions, Anatomical Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases Cardiovascular Diseases Ophthalmoplegia Ocular Motility Disorders |