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

Odense University Hospital

Status and phase

Enrolling

Phase 2

Conditions

Osteoporosis Secondary

Treatments

Drug: Placebo

Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT06421597

2023-506949-27-00

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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).