DISKO: Effect of denosumab on pain and bone marrow lesions in knee osteoarthritis
Osteoarthritis of the knee happens when joint cartilage wears down, causing bones to rub together. This leads to persistent pain, stiffness, and reduced movement. Current treatments mostly manage symptoms rather than stopping joint damage. The DISKO study looks at a medicine called denosumab, which is already used to treat thinning bones. Researchers want to find out if a single injection under the skin can ease knee pain and repair internal joint changes called bone marrow lesions. Participants are randomly chosen to receive either denosumab or a harmless dummy injection (placebo). Everyone takes daily calcium and vitamin D supplements. Over six months, the team monitors participants through knee scans, blood tests, activity trackers, and questionnaires. The goal is to see if treating the underlying bone can provide better relief for people living with arthritis.
At a glance
What is this study about?
Knee osteoarthritis is a very common condition that causes joint pain, swelling, and stiffness. It happens when the smooth, protective cartilage that cushions the ends of your knee bones gradually wears away. Over time, the bones begin to rub directly against each other. This friction often causes painful areas of swelling inside the bone, known as bone marrow lesions. Standard treatments such as painkillers help some people, but they do not stop the condition from getting worse.
This clinical study explores whether treating the bone beneath the cartilage can reduce knee pain. Denosumab is an established medicine typically prescribed to strengthen bones and prevent fractures in people with osteoporosis. Early evidence suggests that protecting the bone might also soothe joint pain and help repair structural damage in knees affected by osteoarthritis.
Researchers at Salford Royal Hospital are running this study to compare a single injection of denosumab against an inactive placebo injection. Half of the participants receive the medicine and half receive the placebo. By following both groups closely, the study team hopes to discover whether bone-targeted therapies offer a safe, effective new treatment for long-term knee pain.
Key takeaways
- Tests whether a single bone-strengthening injection can relieve knee arthritis pain.
- Open to adults aged 40 and older with noticeable knee pain and scan-confirmed arthritis.
- Participants receive either denosumab or a dummy injection, plus daily calcium and vitamin D.
- Involves clinic visits, activity tracking, blood tests, and MRI scans over six months.
- Participation is voluntary and run through Salford Royal Hospital in the UK.
Who may be eligible?
This study is designed for adults aged 40 and older who experience regular knee pain from osteoarthritis. To qualify, your knee pain should be noticeable during your daily life, and you must be able to walk without using a wheelchair. Doctors will confirm your diagnosis using an X-ray and an MRI scan to check for specific joint changes and bone swelling.
You cannot take part if you have other types of joint disease, such as rheumatoid arthritis, gout attacks within the past five years, or a past joint infection in that knee. The trial is also not suitable for people with severe kidney or liver problems, low vitamin D levels, active viral hepatitis, or a recent history of cancer.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 40 or older?
- Do you have regular, painful knee osteoarthritis?
- Can you walk without relying on a wheelchair?
- Are you free from inflammatory arthritis (like rheumatoid arthritis) or recent gout?
- Are you comfortable having MRI scans, blood tests, and wearing a movement tracker?
What does participation involve?
Taking part in the DISKO trial lasts for approximately six months. Before joining, you have an initial screening visit that includes a knee X-ray, an MRI scan, and blood tests to make sure the trial is safe for you. If you are eligible, you are randomly assigned to receive either one injection of denosumab or one dummy injection just under the skin. All participants are given daily calcium and vitamin D supplements to support bone health.
You will attend clinic check-ups at three months and six months. One week before each follow-up visit, you wear a small activity tracker on your body for seven days to measure your movement. At the three-month visit, you complete symptom questionnaires and have a blood test to monitor calcium levels. At six months, you have a second MRI scan and fill in final questionnaires to check whether your knee pain and joint health have improved.
Potential risks and benefits
Locations (1)
- Salford Royal HospitalApproximateSalford, England
Common questions
What is denosumab?
Denosumab is an approved medication that slows down the natural breakdown of bone, helping to keep bones strong.
Will I definitely receive the study drug?
No. You will have an equal chance of receiving either the active medicine or an inactive dummy injection (placebo).
Why do I have to take calcium and vitamin D?
Denosumab works closely with calcium in the body. Taking daily supplements helps keep your blood calcium at safe, healthy levels.
Do I have to pay for the scans or medication?
No. All study-related appointments, scans, blood tests, and trial treatments are provided free of charge.
Can I leave the study early if I change my mind?
Yes. You can leave the study at any point without giving a reason, and your normal healthcare will continue as usual.
How to find out more
Gillian Armitt
Always speak to your GP or specialist before deciding to take part in a study.
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