NCT06421597

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis Secondary

Interventions

Type	Name	Description
DRUG	Prednisolone	prednisoline 25 mg/day for seven days
DRUG	Placebo	Placebo treatment for seven days

Timeline

• Start date: 2024-11-04
• Primary completion: 2026-03-30
• Completion: 2026-04-01
• First posted: 2024-05-20
• Last updated: 2026-04-06

Locations

2 sites across 1 country: Denmark