Not recruiting

Study on Improving Knee Implant Stability in Osteoarthritis Patients Using Denosumab and Zoledronic Acid

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different treatments on patients with osteoarthritis in the knee who are undergoing a type of knee surgery called cementless total knee arthroplasty. The study aims to explore how well the knee implants stay in place and how the surrounding bone changes over time. The treatments being tested include denosumab, which is given as a subcutaneous injection (an injection under the skin), and zoledronic acid, which is applied topically (directly to the area). There is also a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to see if these treatments can improve the stability of the knee implants and the health of the bone around them. Participants will receive one of the treatments or a placebo and will be monitored over time to assess how their knee implants are doing and how their bone density changes. Bone density is a measure of how strong and healthy the bone is, and it will be checked using a method called dual energy x-ray absorptiometry (DXA), which is a type of x-ray that measures bone strength.

The study will also look at certain markers in the body, known as biomarkers, which can give information about bone health and how the body is responding to the treatment. The trial will last for a period of time, during which participants will have regular check-ups to monitor their progress and gather data on the effectiveness of the treatments. The goal is to find out if the treatments can help make the knee implants more stable and improve bone health in patients with knee osteoarthritis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Consent is required to participate.
Eligibility criteria include having primary knee osteoarthritis, being between 18 and 75 years old, and having sufficient bone quality for knee surgery.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the patient's bone quality and overall health status.
This assessment includes imaging tests to measure bone density and other relevant health checks.
Step 3
Randomization and treatment allocation
The patient will be randomly assigned to one of the treatment groups. This process is double-blinded, meaning neither the patient nor the researchers know which treatment is being administered.
The treatments involve either a subcutaneous injection of denosumab or a topical application of zoledronic acid.
Step 4
Treatment administration
The patient will receive the assigned treatment. Denosumab is administered as a subcutaneous injection, while zoledronic acid is applied topically.
The frequency and duration of the treatment will be determined by the study protocol.
Step 5
Follow-up assessments
Regular follow-up assessments will be conducted to monitor the patient's response to the treatment.
These assessments include measuring implant stability using radiostereophotogrammetric analysis (RSA) and evaluating changes in bone mineral density with dual-energy x-ray absorptiometry (DXA).
Step 6
Final evaluation
At the end of the study period, a final evaluation will be performed to assess the long-term effects of the treatment on implant fixation and bone health.
The study is expected to conclude by June 2027.

Who can join the trial?

5 criteria

The patient must have **primary knee osteoarthritis**, which means a type of arthritis that affects the knee joint.
The patient must be a man or woman who is capable, meaning they can understand and make decisions about their health.
The patient must have **sufficient bone quality**, which means their bones are strong enough for a type of knee surgery called total cruciate retaining knee arthroplasty.
The patient must be older than 18 years but not older than 75 years.
The patient must provide **informed and written consent**, which means they understand the study and agree to participate by signing a form.

Who cannot join the trial?

9 criteria

Patients who have had a previous knee replacement surgery on the same knee.
Patients with a known allergy or sensitivity to the study medications, such as **denosumab** or **zoledronic acid**.
Patients with severe kidney problems, as these medications can affect kidney function.
Patients with a history of certain bone diseases, like **osteoporosis**, which is a condition where bones become weak and brittle.
Patients who are currently taking medications that could interfere with the study drugs.
Patients with active infections, as this could complicate the study treatment.
Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
Patients who have participated in another clinical trial within the last 30 days.
Patients with any other medical condition that the study doctors believe would make participation unsafe or affect the study results.

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Verified sites

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Verified
Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Denosumab
is a medication used in this trial to help improve the stability of knee implants. It is given as an injection under the skin. The goal is to see if it can help the bone better support the implant, making it more stable over time.
Zoledronic Acid
is applied topically in this trial. It is used to see if it can help strengthen the bone around the knee implant. By doing so, it may help the implant stay in place better and last longer.

What is already known about the treatment

Denosumab
This medication is administered through subcutaneous injection and is currently being studied for its potential to improve the stability of knee implants in patients undergoing cementless total knee arthroplasty. It is primarily used to treat conditions related to bone loss, such as osteoporosis. Denosumab works by inhibiting a protein involved in bone resorption, thereby reducing bone breakdown and increasing bone density. It is classified as a monoclonal antibody.
Zoledronic Acid
This medication is applied topically in the context of the clinical trial and is being evaluated for its ability to enhance the fixation of knee implants in patients with osteoarthritis undergoing cementless total knee arthroplasty. Zoledronic acid is commonly used to treat high blood calcium levels and bone diseases. It functions by inhibiting osteoclast-mediated bone resorption, leading to increased bone strength. It belongs to the class of drugs known as bisphosphonates.

Investigated diseases

Osteoarthritis in the knee – Osteoarthritis in the knee is a degenerative joint disease characterized by the breakdown of cartilage, leading to pain, stiffness, and reduced mobility in the knee joint. As the cartilage wears away, bones may rub against each other, causing inflammation and further damage. Over time, the joint may become deformed, and bone spurs can develop. The condition typically progresses slowly, with symptoms worsening over the years. It is more common in older adults and can be influenced by factors such as genetics, previous injuries, and obesity. The disease can significantly impact daily activities and quality of life.