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

Phase 2Active Not RecruitingNCT06421597

Odense University Hospital36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoporosis Secondary

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (2)

Hospital of South West Jutland

Esbjerg, Denmark

Odense University Hospital

Odense C, Denmark

Outcomes

Primary Outcomes

Procollagen type 1 N-terminal propeptide (P1NP)

Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8

Time frame: Baseline to day 8

Secondary Outcomes

Collagen 1 cross link C-terminal telopeptide (CTX)

Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15

Time frame: Baseline to day 8 and 15

P1NP (baseline to day 15)

Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15

Time frame: Baseline to day 15

Concentration of Glucocorticoid metabolites

Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8

Time frame: Baseline to day 8

Adipose tissue

Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8

Time frame: Baseline to day 8

Bone tissue

Changes in gene expression in bone tissue from baseline to day 8

Time frame: Baseline to day 8

Glucose

Changes in glucose levels during a mixed meal test from baseline to day 8

Time frame: Baseline to day 8

C-peptid

Changes in c-peptid levels during a mixed meal test from baseline to day 8

Time frame: Baseline to day 8