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Clinical Trials in Denmark / NCT06421597
Active, not recruiting Phase 2

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

NCT06421597 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Phase 2
Started
2024-11-04
Last updated
2026-04-06

Condition(s) studied

Osteoporosis Secondary

Investigational drug(s) / intervention(s)

Prednisolone →Placebo

Prednisolone: prednisoline 25 mg/day for seven days

Placebo: Placebo treatment for seven days

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Men and women aged 18-50 years. Exclusion Criteria: * Uncontrolled thyrotoxicosis * Chronic kidney disease (eGFR \<30) * Known Cushing's syndrome * Previous gastric bypass and/or known ongoing malabsorption * Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment) * Use of oral or inhaled glucocorticoids within the past year * Menopause (defined as 1 year without menstrual bleeding) * Pregnancy (defined as elevated HCG) * Ongoing infection * Allergy to prednisolone or one of the excipients * Systematic fungal infections * Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination * Not able to provide informed consent (e.g., dementia, not able to understand Danish).

Primary outcome measure(s)

  • Procollagen type 1 N-terminal propeptide (P1NP) — Baseline to day 8
    Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8

Trial sites (2)

FacilityCityRegionStatus
Hospital of South West Jutland Esbjerg Denmark
Odense University Hospital Odense C Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06421597 on ClinicalTrials.gov ↗ ← All trials in Denmark