Identifying individuals at risk of bone loss from glucocorticoids
Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease
PHASE2 · Odense University Hospital · NCT06421597
This study is testing if certain markers in the body can help predict which healthy people might lose bone strength from taking glucocorticoids.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 2 sites (Esbjerg and 1 other locations) |
| Trial ID | NCT06421597 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers that can predict which individuals are at risk of experiencing bone loss due to glucocorticoid treatment. It will involve 36 healthy volunteers who will be randomly assigned to receive either glucocorticoids or a placebo. Throughout the study, various samples including blood, bone marrow, bone tissue, and adipose tissue will be collected, and participants will undergo an oral glucose tolerance test to assess metabolic responses. The findings could help tailor glucocorticoid therapy to minimize bone loss in susceptible individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men and women aged 18-50 years without significant health issues.
Not a fit: Patients with uncontrolled thyroid conditions, chronic kidney disease, or those who have had recent severe infections or surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that reduce the risk of glucocorticoid-induced osteoporosis.
How similar studies have performed: While there have been studies on glucocorticoid effects on bone health, this specific approach to identifying biomarkers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Esbjerg and 1 other locations
- Hospital of South West Jutland — Esbjerg, Denmark (NOT_YET_RECRUITING)
- Odense University Hospital — Odense C, Denmark (RECRUITING)
Study contacts
- Principal investigator: Anja Lisbeth Frederiksen, MD — Odense University Hospital
- Study coordinator: Catharina Vind Nielsen, MD
- Email: catharina.vind.nielsen@rsyd.dk
- Phone: +45 21351124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoporosis Secondary