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NCT06395883 Clinical Trial

Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease

Osteoporosis Clinical Trial

— BOOGIE  

Official title:
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06395883
Other study ID # DS-00846
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2024
Est. completion date June 2028

Study information
Verified date April 2024
Source Diakonhjemmet Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, whichmin turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment. There is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date June 2028
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 25 Years to 90 Years
Eligibility Inclusion Criteria: - diagnosis of inflammatory rheumatic joint disease - indication of disease modifying treatment initiation with or without glucocorticoids OR - stable DMARD treatment with parenteral glucocorticoid injection Exclusion Criteria: - known osteoporosis or osteoporosis treatment - women during the transitory phase - oestrogen treatment - any fracture within the last year - chronic glucocorticoid treatment - glucocorticoid treatment within the last year prior to inclusion - active cancer - kidney failure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Glucocorticoid Effect
Patients with or without glucocorticoid treatment will be observed regarding the level of bone turnover markers (P1NP and CTX1) every 4 weeks til 6 months after the last glucocorticoid dose.

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Diakonhjemmet Hospital Hormone Laboratory, Aker University Hospital, Oslo, Norway, Vestre Viken Hospital Trust

Outcome
Type Measure Description Time frame Safety issue
Primary P1NP level 3 months after glucocorticoid termination P1NP in a blood sample august 2024 til december 2025
Secondary P1NP level 6 months after glucocorticoid termination P1NP in a blood sample august 2024 til december 2025
Secondary CTX1 level 3 and 6 months after glucocorticoid termination CTX1 in a blood sample august 2024 til december 2025
Secondary P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids P1NP and CTX1 in a blood sample august 2024 til december 2025
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