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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.

Who May Be Eligible (Plain English)

Who May Qualify: - Men and women aged 18-50 years. Who Should NOT Join This Trial: - 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 willing to sign a consent form (e.g., dementia, not able to understand Danish). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

Prednisolone

prednisoline 25 mg/day for seven days

DRUG

Placebo

Placebo treatment for seven days

Locations (2)

Hospital of South West Jutland
Esbjerg, Denmark
Odense University Hospital
Odense C, Denmark