NCT06421597CompletedPhase 2
Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 3 May 2024
- Start date
- 4 Nov 2024
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Odense University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT06421597
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 36
- From 4 Nov 2024 to the primary completion date, 30 Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastric bypass and/or known ongoing malabsorption
- 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
Other illness
- Known Cushing's syndrome
- Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
- Menopause (defined as 1 year without menstrual bleeding)
- Ongoing infection
- Allergy to prednisolone or one of the excipients
- Systematic fungal infections
- Not able to provide informed consent (e.g., dementia, not able to understand Danish).
Lab values
- Chronic kidney disease (eGFR \<30)
Other
- Uncontrolled thyrotoxicosis
- Use of oral or inhaled glucocorticoids within the past year
- Pregnancy (defined as elevated HCG)
Who the study is looking for
- Men and women aged 18-50 years.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of South West Jutland Coordinator of this site? Confirm its status | Esbjerg | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.