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

NCT06421597 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-06

No results posted yet for this study

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

DRUG

Prednisolone

prednisoline 25 mg/day for seven days

DRUG

Placebo

Placebo treatment for seven days

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • University of Ulm

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Anja Lisbeth Frederiksen, MD · Odense University Hospital

  • Claus Bogh Juhl, MD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2026-03-30
Completion
2026-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421597 on ClinicalTrials.gov