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

NCT06421597 | Recruiting Phase 2

• 1 other identifier: 2023-506949-27-00
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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 an oral glucose tolerance test is performed.

Conditions

Osteoporosis Secondary

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to day 8

Secondary Outcomes (7)

• Collagen 1 cross link C-terminal telopeptide (CTX)

  Baseline to day 8 and 15

• P1NP (baseline to day 15)

  Baseline to day 15

• Concentration of Glucocorticoid metabolites

  Baseline to day 8

• Adipose tissue

  Baseline to day 8

• Bone tissue

  Baseline to day 8

Other Outcomes (1)

• Biomarker

  Baseline

Study Arms (2)

Prednisolone group

EXPERIMENTAL

Drug: Prednisolone

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prednisolone DRUG

prednisoline 25 mg/day for seven days

Prednisolone group

Placebo DRUG

Placebo treatment for seven days

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18-50 years.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Odense University Hospital: lead
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• University of Ulm: collaborator
• University of Birmingham: collaborator

Study Sites (2)

Hospital of South West Jutland

Esbjerg, 6700, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anja Lisbeth Frederiksen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Claus Bogh Juhl, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catharina Vind Nielsen, MD

CONTACT

+45 21351124; catharina.vind.nielsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 20, 2024
• Study Start: November 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)