NCT06421597

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

Odense University Hospital·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Osteoporosis Secondary
Drug/Device/Intervention
Prednisolone
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Odense University Hospital
Location
Esbjerg,Odense C, Denmark
Timeline & enrollment
Phase
Phase 2
Start date
May 01, 2024
End date
Dec 01, 2025
Enrollment
36 participants
Primary outcome

Procollagen type 1 N-terminal propeptide (P1NP)

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 a mixed meal test is performed.

ICD-10 classifications
Other osteoporosisOsteoporosis, unspecifiedIdiopathic osteoporosisOsteoporosis in diseases classified elsewhereOsteoporosis in other diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421597
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06421597 through Pure Global AI's free database. This Phase 2 trial is sponsored by Odense University Hospital and is currently Not yet recruiting. The study focuses on Osteoporosis Secondary. Target enrollment is 36 participants.

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