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NCT Number: NCT06421597

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoporosis Secondary

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital of South West Jutland, Esbjerg, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prednisolone

Drug

prednisoline 25 mg/day for seven days

Placebo

Drug

Placebo treatment for seven days

Primary outcomes

  1. Procollagen type 1 N-terminal propeptide (P1NP)

    Time frame: Baseline to day 8

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

Secondary outcomes

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

    Time frame: 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

  2. P1NP (baseline to day 15)

    Time frame: Baseline to day 15

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

  3. Concentration of Glucocorticoid metabolites

    Time frame: Baseline to day 8

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

  4. Adipose tissue

    Time frame: Baseline to day 8

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

  5. Bone tissue

    Time frame: Baseline to day 8

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

  6. Glucose

    Time frame: Baseline to day 8

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

  7. C-peptid

    Time frame: Baseline to day 8

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

Other outcomes

  1. Biomarker

    Time frame: Baseline

    Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark
  • University of Birmingham
  • University of Ulm

Registry information

Acronym: RIGID

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 20, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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