Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease

Launched by ODENSE UNIVERSITY HOSPITAL · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how some people experience more bone loss than others when they take glucocorticoids, which are medications often used to treat various conditions. Researchers want to find a specific marker in the body, called a biomarker, that can help identify individuals at risk of losing bone mass during this treatment. The study will involve 36 healthy volunteers aged between 18 and 50 years, who will be randomly assigned to either receive glucocorticoid treatment or a placebo (a harmless substance that looks like the treatment but has no effect). Participants will provide blood, bone marrow, and tissue samples, and undergo a glucose tolerance test, which helps measure how well their body processes sugar.

To be eligible for this study, participants must be healthy men or women aged 18 to 50 years. However, certain conditions may exclude someone from participating, such as having uncontrolled thyroid issues, chronic kidney disease, or certain infections. It's important to know that the study aims to help improve understanding of how glucocorticoids affect bone health, which could lead to better treatments in the future. If you think you might be interested in participating, please consult with your healthcare provider to see if you meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18-50 years.
• Exclusion Criteria:
• • Uncontrolled thyrotoxicosis
• • Chronic kidney disease (eGFR \<30)
• • Known Cushing's syndrome
• • Previous gastric bypass and/or known ongoing malabsorption
• • Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
• • Use of oral or inhaled glucocorticoids within the past year
• • Menopause (defined as 1 year without menstrual bleeding)
• • Pregnancy (defined as elevated HCG)
• • Ongoing infection
• • Allergy to prednisolone or one of the excipients
• • Systematic fungal infections
• • Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination
• • Not able to provide informed consent (e.g., dementia, not able to understand Danish).

Trial Officials