A Phase 2 interventional study of Prednisolone and Placebo in Osteoporosis Secondary, sponsored by Odense University Hospital. Active, not recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Odense University Hospital · Phase 2, Interventional, and Treatment
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.
Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Prednisolone
Drug: Placebo
prednisoline 25 mg/day for seven days
Placebo treatment for seven days
Procollagen type 1 N-terminal propeptide (P1NP)
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8
Time frame: Baseline to day 8
Collagen 1 cross link C-terminal telopeptide (CTX)
Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15
Time frame: Baseline to day 8 and 15
P1NP (baseline to day 15)
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15
Time frame: Baseline to day 15
Concentration of Glucocorticoid metabolites
Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8
Time frame: Baseline to day 8
Adipose tissue
Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8
Time frame: Baseline to day 8
Bone tissue
Changes in gene expression in bone tissue from baseline to day 8
Time frame: Baseline to day 8
Glucose
Changes in glucose levels during a mixed meal test from baseline to day 8
Time frame: Baseline to day 8
C-peptid
Changes in c-peptid levels during a mixed meal test from baseline to day 8
Time frame: Baseline to day 8
Biomarker
Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss
Time frame: Baseline
Plan to share: No — Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Odense University Hospital