Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:
• Men and women aged 18-50 years.
Locations
Other Locations
Denmark
Hospital of South West Jutland
NOT_YET_RECRUITING
Esbjerg
Odense University Hospital
RECRUITING
Odense C
Contact Information
Primary
Catharina Vind Nielsen, MD
catharina.vind.nielsen@rsyd.dk
+45 21351124
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 36
Treatments
Experimental: Prednisolone group
Placebo_comparator: Placebo group
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Ulm, University of Birmingham, Esbjerg Hospital - University Hospital of Southern Denmark