Clinical trial NCT06421597: Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease
Official title: Identifying Individuals At Risk of Glucocorticoid-Induced Impairment of Bone Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoporosis Secondary
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Esbjerg Hospital - University Hospital of Southern Denmark
name: University of Ulm
name: University of Birmingham
First posted: 2024-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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\&#39; 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 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).

Primary outcomes:
measure: Procollagen type 1 N-terminal propeptide (P1NP)
timeFrame: Baseline to day 8
Secondary outcomes:
measure: Collagen 1 cross link C-terminal telopeptide (CTX)
timeFrame: Baseline to day 8 and 15
measure: P1NP (baseline to day 15)
timeFrame: Baseline to day 15
measure: Concentration of Glucocorticoid metabolites
timeFrame: Baseline to day 8
measure: Adipose tissue
timeFrame: Baseline to day 8
measure: Bone tissue
timeFrame: Baseline to day 8
measure: Glucose
timeFrame: Baseline to day 8
measure: C-peptid
timeFrame: Baseline to day 8
Other outcomes:
measure: Biomarker
timeFrame: Baseline
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Anja Lisbeth Frederiksen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Claus Bogh Juhl, MD
role: PRINCIPAL_INVESTIGATOR
References: