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

Phase 1
Conditions
Secondary Osteoporosis
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Registration Number
CTIS2023-506949-27-00
Lead Sponsor
Odense University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
36
Inclusion Criteria

Men and women aged 18-50 years

Exclusion Criteria

Uncontrolled thyrotoxicosis, 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). At the information meeting the investigator will make an individual assessment to evaluate whether a potential study participants understand the information., 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 GCs within the past year, Menopause (defined as 1 year without menstrual bleeding), Pregnancy (defined as elevated HCG), Ongoing infection

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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