Study to Identify Patients at Risk of Bone Disease from Glucocorticoids Using Prednisolone and Placebo

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What is this study about?

This clinical trial is focused on studying a condition known as Secondary Osteoporosis, which is a type of bone disease that can occur due to the use of certain medications. The study will explore the effects of a medication called Prednisolone, which is commonly used to treat inflammation and other conditions. Participants in the study will receive either Prednisolone or a Placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to identify markers in the body that can help detect individuals who are at risk of developing bone problems due to the use of medications like Prednisolone. During the study, participants will take the medication or placebo for a short period, and researchers will monitor changes in specific substances in the blood and tissues. These substances include proteins and genes that are involved in bone health and metabolism.

The study will involve several visits where blood samples will be taken to measure levels of certain proteins, such as P1NP and CTX, which are indicators of bone health. Additionally, changes in gene expression in fat and bone tissues will be examined. The study aims to provide valuable information that could help in predicting and preventing bone disease in people who need to take medications like Prednisolone.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to identify individuals at risk of glucocorticoid-induced impairment of bone disease.

2 initial assessment

An initial assessment will be conducted to establish baseline measurements. This includes collecting a blood sample to measure levels of certain markers, such as P1NP and CTX, which are indicators of bone health.

3 medication administration

You will be randomly assigned to receive either a placebo or prednisolone 25mg tablets. The medication will be taken orally, once daily, for a duration of 7 days.

4 follow-up assessments

Follow-up assessments will be conducted on day 7 and day 14. These assessments will involve collecting blood samples to measure changes in the levels of P1NP and CTX, as well as other markers related to bone health and metabolism.

Additional tests may include evaluating changes in gene expression in fat and bone tissue, and assessing insulin secretion and sensitivity.

5 completion of study participation

After the final assessment on day 14, your participation in the study will be complete. The information gathered will contribute to understanding the risk factors for glucocorticoid-induced bone disease.

Who Can Join the Study?

Men and women aged 18-50 years
Individuals with Secondary Osteoporosis, which is a condition where bones become weak due to another medical issue

Who Cannot Join the Study?

Patients with Secondary Osteoporosis cannot participate. This is a condition where bones become weak due to another disease or condition.
Patients who are at risk of Glucocorticoid-Induced Impairment of Bone Disease are not eligible. Glucocorticoids are a type of steroid medication that can affect bone health.
Patients who are not within the specified age range for the study cannot participate. The study is open to a specific age group.
Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
Patients who are considered part of a vulnerable population are not eligible. This means individuals who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Glucocorticoids are a type of medication often used to reduce inflammation in the body. They are commonly prescribed for conditions like asthma, arthritis, and allergies. However, long-term use of glucocorticoids can lead to side effects, including weakening of the bones, which is known as bone disease. This study aims to find out which individuals are at risk of developing bone disease when taking glucocorticoids.

Investigated diseases:

Osteoporosis

Secondary Osteoporosis – Secondary Osteoporosis is a condition where bones become weak and brittle due to an underlying medical issue or medication use, rather than aging or menopause. It often results from prolonged use of glucocorticoids, which can interfere with bone rebuilding processes. The disease progresses as bone density decreases, making bones more susceptible to fractures. Over time, individuals may experience a reduction in height and a stooped posture due to vertebral fractures. The condition can also lead to chronic pain and reduced mobility. It is important to monitor bone health regularly to manage the progression of this disease.

Trial ID:

2023-506949-27-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study to Identify Patients at Risk of Bone Disease from Glucocorticoids Using Prednisolone and Placebo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?