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| Name | Class |
|---|---|
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| University of Ulm | OTHER |
| University of Birmingham | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | prednisoline 25 mg/day for seven days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to day 8 and 15 |
| P1NP (baseline to day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anja Lisbeth Frederiksen, MD | Odense University Hospital | Principal Investigator |
| Claus Bogh Juhl, MD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of South West Jutland | Esbjerg | 6700 | Denmark | |||
| Odense University Hospital |
Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo |
| Drug |
Placebo treatment for seven days |
|
Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15
| Baseline to day 15 |
| Concentration of Glucocorticoid metabolites | Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8 | Baseline to day 8 |
| Adipose tissue | Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8 | Baseline to day 8 |
| Bone tissue | Changes in gene expression in bone tissue from baseline to day 8 | Baseline to day 8 |
| Glucose | Changes in glucose levels during a mixed meal test from baseline to day 8 | Baseline to day 8 |
| C-peptid | Changes in c-peptid levels during a mixed meal test from baseline to day 8 | Baseline to day 8 |
| Odense C |
| 5000 |
| Denmark |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |