Osteoporosis Secondary
Conditions
Brief summary
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.
Interventions
DRUGPrednisolone
prednisoline 25 mg/day for seven days
DRUGPlacebo
Placebo treatment for seven days
Sponsors
Odense University Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
University of Ulm
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procollagen type 1 N-terminal propeptide (P1NP) | Baseline to day 8 | Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collagen 1 cross link C-terminal telopeptide (CTX) | Baseline to day 8 and 15 | Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15 |
| P1NP (baseline to day 15) | Baseline to day 15 | Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15 |
| Concentration of Glucocorticoid metabolites | Baseline to day 8 | Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8 |
| Adipose tissue | Baseline to day 8 | Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8 |
| Bone tissue | Baseline to day 8 | Changes in gene expression in bone tissue from baseline to day 8 |
| Glucose | Baseline to day 8 | Changes in glucose levels during a mixed meal test from baseline to day 8 |
| C-peptid | Baseline to day 8 | Changes in c-peptid levels during a mixed meal test from baseline to day 8 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORAnja Lisbeth Frederiksen, MD
Odense University Hospital
PRINCIPAL_INVESTIGATORClaus Bogh Juhl, MD
Esbjerg Hospital - University Hospital of Southern Denmark
Outcome results
None listed