AuthorisedTherapeutic exploratory (Phase II)Interventional

Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)

Erosive hand osteoarthritis is a painful condition where finger joints become inflamed and the bone underneath wears away. This study, called the ZODIAC trial, is investigating whether bone-strengthening medicines can protect the joints of people who have both osteoporosis and erosive hand osteoarthritis. Participants will be given one of two existing bone medications: denosumab (given as an injection under the skin) or zoledronic acid (given as a slow drip into a vein). Over 12 months, doctors will track changes using special high-detail scans of the fingers to see if the treatments slow down or stop joint erosion. Participants will also complete simple surveys about their hand pain, stiffness, and ability to carry out everyday tasks. The main goal is to find out if these medicines can help people keep their hand function and live with less pain.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrolment target

150

Start

14 Aug 2026

Erosive hand osteoarthritis (EHOA)

What is this study about?

Osteoarthritis is very common, but a form called 'erosive hand osteoarthritis' causes sudden swelling, redness, and severe pain in the finger joints. Over time, the bone inside these joints begins to erode or wear away. This can make simple, everyday tasks like opening jars, writing, or buttoning clothes difficult and uncomfortable. Currently, doctors have very few treatments that can slow down this bone damage.

Osteoporosis is another condition where bones lose strength and become more fragile. Doctors routinely treat osteoporosis with medicines that protect bone, such as denosumab and zoledronic acid. Researchers believe that because these drugs are so good at strengthening bone tissue, they might also stop the painful bone erosion seen in hand osteoarthritis.

The ZODIAC clinical trial compares these two medicines head-to-head over one year. By taking detailed 3D pictures of the finger bones and listening to patient feedback, researchers hope to discover which medicine works best to protect joints and improve daily life. The results could provide a new way to treat this painful condition in the future.

Key takeaways

The ZODIAC study tests two bone-strengthening drugs in people with osteoporosis and erosive hand arthritis.
It compares denosumab (injection) with zoledronic acid (drip) over 12 months.
Specialised, painless 3D scans will track whether the drugs stop bone erosion in finger joints.
The goal is to reduce joint pain and help people maintain better hand function.
Joining is voluntary, and you are free to leave the trial at any point.

Who may be eligible?

This trial is open to adults aged 18 and older of any sex. To be considered, you must have been diagnosed with both osteoporosis (fragile bones) and erosive osteoarthritis affecting your finger joints.

You will need to be able to attend regular clinic appointments over a 12-month period and undergo hand scans.

Certain health conditions, previous bone medications, or allergies might mean this trial is not suitable for you. A doctor on the research team will review your full medical history with you to make sure taking part is safe.

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.

You are aged 18 or older.
You have been diagnosed with osteoporosis.
You have painful, erosive osteoarthritis in your finger joints.
You can travel to clinic appointments over a 12-month period.
You are comfortable receiving either an injection or an intravenous drip.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for about 12 months. You will be randomly assigned to receive either denosumab (an injection just under the skin) or zoledronic acid (an infusion given through a drip into your arm). You will have around four main clinic appointments during the year. At these visits, the research team will check your general health, take blood samples, and ask you to fill in short questionnaires about your hand pain, grip, and daily activities. You will also have painless, detailed 3D scans of your hands at the start of the study and after 12 months so doctors can measure any changes in your finger bones.

Potential risks and benefits

You may benefit from treatments that strengthen your bones and potentially reduce joint damage and hand pain, though this cannot be guaranteed. The information collected will also help doctors improve care for other patients in the future. As with all medications, there is a chance of side effects. Zoledronic acid can sometimes cause short-lived flu-like symptoms, while denosumab can cause mild irritation where the injection was given. The study team will monitor you closely at all times. Taking part is completely voluntary, and you can withdraw at any point without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is erosive hand osteoarthritis?

It is an aggressive type of hand arthritis where inflammation causes the bone in the finger joints to slowly wear away, causing pain, swelling, and stiffness.

How are the two medicines given?

Denosumab is given as a quick injection under the skin, while zoledronic acid is given through a drip into a vein in your arm.

Are the hand scans painful?

No. The scans are completely painless and non-invasive. You simply place your hand inside a special scanner for a short period.

Will I have to pay for any of the treatments?

No. All study medications, tests, and scans are provided free of charge, and help with travel expenses may be available.

Can I leave the study if I change my mind?

Yes. You are free to stop taking part at any time, for any reason, and your regular medical care will continue as normal.