Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease (RIGID)

This study, called RIGID, is designed to understand how a commonly used steroid medication, prednisolone, affects bone health. When people take steroids for a long time, it can sometimes lead to bones becoming weaker, a condition called osteoporosis. We are looking for early changes in blood tests that might tell us if someone is likely to develop this problem, even before it becomes serious. Participants will receive either a low dose of prednisolone or a dummy pill (placebo). By studying various markers in the blood and other tissues, we hope to discover ways to identify people at risk and, in the future, prevent bone weakening caused by these important medicines.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

Start

27 Mar 2024

Secondary Osteoporosis

What is this study about?

Many people rely on steroid medications like prednisolone to treat conditions like asthma, arthritis, or inflammatory bowel disease. While these medicines are very effective, long-term use can sometimes lead to a side effect where bones become thin and weak, a condition called osteoporosis. This study, named RIGID, aims to understand this process better.

Our main goal is to find early warning signs. We want to see if specific substances in a person's blood change quickly when they start taking prednisolone. These changes could act like a 'red flag' to tell doctors if someone is at higher risk of developing weaker bones in the future. If we can spot these risks early on, doctors might be able to offer preventative treatments or adjust medication to protect bone health before serious problems occur.

To do this, some study participants will take a small dose of prednisolone, and others will take a dummy pill (placebo). Over a short period, we will carefully measure different things in their blood and other tissues. This detailed look will help us learn which changes are linked to prednisolone's effects on bones. Ultimately, this research hopes to make steroid treatment safer for patients by protecting their bone health.

Key takeaways

Aims to find early signs of bone weakening from steroid use.
Studies a low dose of prednisolone or a dummy pill.
Focuses on changes in blood tests.
Involves a few short clinic visits.
Helps develop safer steroid treatments for the future.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. Both men and women are welcome to take part.

There will be specific health checks to make sure the study is safe and right for you. For example, you wouldn't be able to join if you already have certain bone conditions, kidney problems, or are taking medications that significantly affect your bones.

The research team will go through all the detailed requirements with you to see if you are a good fit for this study.

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?
Are you generally healthy, without major kidney or liver problems?
Do you not have a serious bone condition already?
Are you not currently taking strong medications that affect your bones?
Are you comfortable with blood tests and potentially small tissue samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either a small dose of prednisolone tablets or a dummy pill (placebo) for a short period. You won't know which one you are taking. You will need to visit the study clinic several times, usually on day 0 (the start), day 7, and potentially day 14. At these visits, we will take blood samples to measure the different markers we're interested in. We might also collect small tissue samples (like a tiny skin sample) to look at other changes.

Each visit will involve health checks and discussions about how you are feeling. The total duration of your active involvement in the study, including all treatments and assessments, will be up to 14 days. After this, there might be a final follow-up to check your general health.

Potential risks and benefits

Taking part in any research has both potential benefits and risks. You might not directly benefit from taking part, but your contribution will help us learn more about how to protect bone health for many other patients in the future. Potential risks could include side effects from the prednisolone (though it's a very low dose for a short time), discomfort from blood tests and tissue biopsies, or the inconvenience of clinic visits. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Denmark

Common questions

What is osteoporosis?

Osteoporosis is a condition where bones become weak and fragile, making them more likely to break.

What are steroid medications?

Steroid medications (like prednisolone) are powerful anti-inflammatory drugs used to treat many different health conditions.

Why is it called a 'Phase II' study?

Phase II means it's an early-stage study aimed at exploring how the treatment works and understanding its effects, rather than proving it cures a disease.

Will I know if I'm taking the dummy pill?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're taking prednisolone or the placebo. This helps make the results more reliable.

How long will I be involved in the study?

Your active involvement with medication and assessments will be for a maximum of 14 days.