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

NCT ID: NCT06421597

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis Secondary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prednisolone group

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

prednisoline 25 mg/day for seven days

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo treatment for seven days

Interventions

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Prednisolone

prednisoline 25 mg/day for seven days

Intervention Type DRUG

Placebo

Placebo treatment for seven days

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anja Lisbeth Frederiksen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Claus Bogh Juhl, MD

Role: PRINCIPAL_INVESTIGATOR

Esbjerg Hospital - University Hospital of Southern Denmark

Locations

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Hospital of South West Jutland

Esbjerg, , Denmark

Site Status NOT_YET_RECRUITING

Odense University Hospital

Odense C, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Catharina Vind Nielsen, MD

Role: CONTACT

[email protected]
+45 21351124

Facility Contacts

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Catharina Vind Nielsen, MD

Role: primary

[email protected]
+45 21351124

Catharina Vind Nielsen, MD

Role: primary

[email protected]
+45 21351124

Other Identifiers

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2023-506949-27-00

Identifier Type: -

Identifier Source: org_study_id