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Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease (RIGID)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506949-27-00
Enrollment
36
Registered
2024-03-27
Start date
2024-10-14
Completion date
Unknown
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Osteoporosis

Brief summary

Changes in the level of P1NP in peripheral blood from baseline to day 7

Detailed description

Changes in the level of CTX in peripheral blood from baseline to day 7 and 14, Changes in the level of P1NP in peripheral blood from baseline to day 14, Changes in GC metabolites in blood from baseline to day 7 (e.g., prednisone levels, and the prednisolone/prednisone ratio), Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 7 (e.g., adiponectin or visfatin), Changes in gene expression in bone tissue from baseline to day 7 (e.g., RUNX2 or osteocalcin), Changes in insulin secretion and sensitivity from baseline to day 7

Interventions

DRUGPrednisolone 25mg Tablets
DRUGPLACEBO

Sponsors

Odense University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Changes in the level of P1NP in peripheral blood from baseline to day 7

Secondary

MeasureTime frame
Changes in the level of CTX in peripheral blood from baseline to day 7 and 14, Changes in the level of P1NP in peripheral blood from baseline to day 14, Changes in GC metabolites in blood from baseline to day 7 (e.g., prednisone levels, and the prednisolone/prednisone ratio), Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 7 (e.g., adiponectin or visfatin), Changes in gene expression in bone tissue from baseline to day 7 (e.g., RUNX2 or osteocalcin), Changes in insulin secretion and sensitivity from baseline to day 7

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026