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

Phase 2

Recruiting

• Conditions: Osteoporosis Secondary
• Interventions: Drug: Prednisolone; Drug: Placebo

• Registration Number: NCT06421597
• Lead Sponsor: Odense University Hospital

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' 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 a mixed meal test is performed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Status Verified: 2024-11
• Study Start: 2024-11-04
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone group	Prednisolone	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Bone tissue	Baseline to day 8	Changes in gene expression in bone tissue from baseline to day 8
Collagen 1 cross link C-terminal telopeptide (CTX)	Baseline to day 8 and 15	Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15
P1NP (baseline to day 15)	Baseline to day 15	Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15
Concentration of Glucocorticoid metabolites	Baseline to day 8	Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8
Adipose tissue	Baseline to day 8	Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8
Glucose	Baseline to day 8	Changes in glucose levels during a mixed meal test from baseline to day 8
C-peptid	Baseline to day 8	Changes in c-peptid levels during a mixed meal test from baseline to day 8

Trial Locations

Locations (2)

Hospital of South West Jutland; 🇩🇰 Esbjerg, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark