Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Senolytics to Improve Osteoporosis therapy: A randomised controlled clinical trial The SENIOR Trial

The SENIOR Trial is a research study investigating a new way to treat bone thinning conditions like osteopenia and osteoporosis. It’s looking at a medicine called DASATINIB, which falls into a group of drugs known as senolytics. These drugs are thought to improve health by getting rid of old, damaged cells that can contribute to age-related problems, including bone weakening. The main goal is to see if DASATINIB can reduce how quickly bone is broken down, which is a key issue in osteoporosis. We'll be doing this by checking levels of a specific marker in the blood after 21 weeks. The study also looks at other blood markers related to both bone breakdown and bone building to get a fuller picture of the effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

120

Start

01 Mar 2023

osteopenia Osteoporosis

What is this study about?

Imagine your bones are like a building that's always being repaired. Old parts are taken down, and new parts are put up. In conditions like osteopenia and osteoporosis, this balance is off, and more old bone is taken down than new bone is built. This makes bones weaker and more likely to break. This study, called THE SENIOR Trial, is testing a new approach to help restore this balance.

The medicine being studied is called DASATINIB. It's a type of drug known as a 'senolytic'. Senolytics are being explored because they can remove certain old, 'worn-out' cells in the body that can cause problems, including those that might contribute to bones getting weaker. By removing these old cells, we hope to improve the health of your bones.

We will be looking closely at how DASATINIB affects specific markers in your blood. These markers are like signals that tell us how much bone is being broken down and how much new bone is being formed. By measuring these signals over 21 weeks, we hope to understand if DASATINIB can help slow down bone breakdown, potentially leading to stronger bones in the long run. This is a Phase II trial, which means it’s an early-stage study to see if the treatment is effective and safe.

Key takeaways

This study is testing a new medicine (DASATINIB) for weak bones.
It aims to see if DASATINIB can slow down bone breakdown.
Participation involves regular clinic visits and blood tests over 21 weeks.
Both men and women aged 18+ with osteopenia or osteoporosis may be eligible.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and over, who have osteopenia or osteoporosis. Osteopenia means your bones are weaker than normal, but not as weak as osteoporosis. Osteoporosis means your bones are very weak and more likely to break easily.

Both men and women can take part in this study. The research team will need to check your medical history and do some tests to make sure that DASATINIB would be a safe and suitable option for you.

It’s important that participants meet all the study's requirements to ensure their safety and the reliability of the study results. The research team will discuss these details with you during a screening visit.

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 18 years old or older?
Have you been diagnosed with osteopenia or osteoporosis?
Are you able to attend regular appointments at the study clinic?
Are you willing to have blood tests as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in THE SENIOR Trial, you would receive the study medicine, DASATINIB. You would have several visits to the clinic over a period of 21 weeks (about 5 months). During these visits, the research team would carry out different assessments. These may include blood tests to measure the bone markers we are interested in, and other checks to monitor your health and how you are responding to the treatment. There will also be follow-up calls or visits after the main treatment period to see how you are doing. The doctors and nurses will explain each step to you in detail.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health. However, like all medicines, DASATINIB may have side effects, and some benefits might not be experienced by everyone. The research team will explain all known potential risks and side effects to you. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your medical 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
Denmark

Common questions

What is osteopenia and osteoporosis?

Both are conditions where your bones are weaker than they should be, making them more likely to break. Osteoporosis is a more severe form than osteopenia.

What is DASATINIB?

It's the medicine being tested in this study. It's a type of drug called a 'senolytic', which aims to remove old, damaged cells that might contribute to bone weakening.

What are 'bone markers'?

Bone markers are substances found in your blood that tell us how quickly your body is breaking down old bone and building new bone. We use them to see if the treatment is having an effect.

How long will the study last if I join?

The main part of the study involves taking the medicine and having check-ups over 21 weeks (about 5 months), with follow-up appointments afterwards.

Will I know if I'm getting the active drug or a dummy pill?

This is a randomised controlled trial, which means you will be randomly assigned to receive either DASATINIB or a comparison treatment, but you won't know which one you are getting. This helps us get fair results.