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

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What is this study about?

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.

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.

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.

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.

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.

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).

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Afafpr Utdjghokgd Hvxvwury	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.06.2014

Trial locations

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.

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.

Trial ID:

2024-514903-33-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?