FAQs

Frequently Asked Questions

about the TOPAZ Study

Who is leading the TOPAZ clinical trial?

The TOPAZ doctors are experts in Parkinson’s disease and zoledronate treatment.  The doctors who are conducting the TOPAZ trial, include neurologists who are experienced experts in Parkinson’s disease and parkinsonism, including Lewy Body Dementia (LBD), progressive supranuclear palsy (PSP), and multiple system atrophy (MSA).  Several TOPAZ doctors are experienced experts in zoledronate and osteoporosis (weak bones).  They are available to answer questions that come up about the trial and the study treatment.  This clinical trial is being funded by the National Institutes of Health.   

I do not have falls. Is this study right for me?

Yes.  Patients with Parkinson’s disease or parkinsonism are at greater risk of fracture than others of the same age or sex, and may suffer a fracture even the 1st time they fall.  Even if you do not fall or have a fracture, it is possible that zoledronate may reduce the risk of death from all causes. TOPAZ is studying that possible benefit. 

I’ve had a fracture.  Am I still eligible for the study?

Yes, you are eligible to participate if you’ve had any type of fracture except a hip fracture.

Is the study treatment, zoledronate, approved by the FDA?

Yes, zoledronate is already approved by the FDA and has been used by many doctors and patients for the treatment of osteoporosis.  TOPAZ is testing whether it reduces fractures in people with Parkinson’s disease and parkinsonism, and whether it also reduces the chance of dying of any cause.

Can I take other medications while I am in the TOPAZ study?

Yes, it is safe to take other types of medications before or after receiving the one-time study treatment – zoledronate or placebo.  If you have any questions about a medication, check with your doctor. 

 

However, TOPAZ study participants cannot to take other drug therapies for osteoporosis, such as Fosamax, because it may interfere with the results of the study.  If you suspect you are a candidate for osteoporosis treatment now, please discuss study participation with your doctor.

Can I participate in other trials while I am in the TOPAZ study?

With the exception of studies focused on bone health, which could interfere with TOPAZ study results, you may participate in any other study, including studies of drug treatments for Parkinson’s disease or parkinsonism.  If you are enrolled in another study which involves an infusion of medication or the injection of contrast for an imaging study, please let us know, as this could affect the timing of your TOPAZ infusion.

Can I receive the COVID-19 vaccine around the time of the study treatment?

Yes, you may take the COVID-19 vaccine during this study, but we recommend that you receive the vaccine at least one week before or after the study treatment.  Some side effects of the COVID-19 vaccine are similar to the flu-like symptoms that can happen after the study treatment.  However, zoledronate does not cause a sore arm. 

At the 1-time home visit, what precautions do the study nurses take to reduce the risk of COVID-19 infection?

The study nurses contact participants before the home visit to check whether the participant has symptoms that might indicate COVID-19 infection.  In addition, nurses will not conduct home visits if they are symptomatic or have tested positive for COVID-19.  All nurses who do home visits will wear an appropriate type of mask and provide a mask for the participant to wear.  If you are not comfortable having a nurse in your home, the visit may be performed outside, such as on your porch or in your backyard.

The study description says that I'll need to take Vitamin D, for at least a week, before the study treatment.  I already take Vitamin D.  May I continue to take my own supplements? 

Yes, if you are already taking at least 800 IU of Vitamin D per day, you may continue to take your own supply if you wish. 

For those who are not taking Vitamin D, we require that you take two tablets per day for at least a week before your home visit and 1-time study treatment.   We will send you a bottle of Vitamin D (before your home visit) after you’ve completed the initial enrollment steps.

Are there side-effects from receiving the study treatment?

Participants in TOPAZ receive one I.V. (intravenous) infusion of zoledronate or placebo.  About 1 out of 10 people who receive zoledronate have mild flu-like symptoms such as low-grade fever and muscle pain.  Occasionally, people may also experience bone pain, nausea, or fatigue.  The symptoms decrease over time and usually do not last more than 3 days.  Study participants will get acetaminophen (Tylenol) before the infusion to reduce the chance and severity of these possible symptoms.  Those who have had problems with acetaminophen in the past will take a different nonsteroidal anti-inflammatory, such as ibuprofen.

I have heard that osteonecrosis of the jaw (ONJ) is a side effect of zoledronate.  What is this? 

Osteonecrosis of the jaw (ONJ) is a rare condition that only occurs in less than 1 in 10,000 people who receive zoledronate.  It is a painful sore on the gum that can be slow to heal and it generally occurs as a result of surgery on the gum tissue, but people who have a sore or gum problem might also have a risk of ONJ.

To ensure your safety, we are carefully screening everyone before they are enrolled in the study.  We will ask you about any recent or planned tooth extractions, and will schedule your visit after you have fully recovered.  We will also perform a comprehensive oral exam at the home visit, before we administer the study drug.  If during the home exam, the study nurse thinks that you may be at risk of getting ONJ, you will not receive the study treatment.

Can I have dental work and receive the study treatment? 

Some types of dental surgery, such as tooth extraction,  may increase the risk of ONJ.  Filling cavities and dental cleaning does not increase the chance of ONJ.  Patients who plan to have tooth extractions may have their home visit put on hold for at least 3 months following a tooth extraction.  Or you may receive the study treatment (zoledronate or placebo) if the extraction will not occur for 6 months.

I’ve heard that zoledronate can sometimes cause fractures.  Is this true?

Zoledronate strengthens bone and reduces the risk of fracture in patients with osteoporosis.  Very rarely - about 1 in 50,000 people who have a single dose of zoledronate, as in TOPAZ - may develop a fracture of the femur (thigh bone) called ‘atypical femur fracture’ because of unusual characteristics on x-ray.  By comparison, a patient with Parkinson’s disease has about a 1 in 20 chance of having a hip fracture in 2 years. 

Does zoledronate cause kidney problems?

Treatment with zoledronate very rarely causes a temporary decrease in measurements of kidney function.  This has been found to occur in less than 1 in 100 patients who already have reduced kidney function. 

 

However, this possible side-effect is extremely rare in those who have normal renal function.  Therefore, we also screen for abnormal renal function at the home visit and exclude anyone (from the study) who has renal insufficiency or poor kidney function.

Will I be able to find out whether I received zoledronate or placebo?

Yes, participants will be notified about which group they were assigned to after the trial has ended.