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

Not yet recruiting

• Conditions: Osteoporosis; Inflammatory Rheumatism; Osteoporosis, Steroid Induced
• Interventions: Drug: Glucocorticoid Effect

• Registration Number: NCT06395883
• Lead Sponsor: Diakonhjemmet Hospital

Brief 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, which in 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Study Start: 2024-09
• Primary Completion: 2025-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RApre	Glucocorticoid Effect	Patients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be premenopausal and men younger than 50 years.
IA	Glucocorticoid Effect	Patients with an inflammatory joint disease on stable DMARD treatment weith indication of intraarticular glucocorticoid injection. Women should be premenopausal and men younger than 50 years.
RApost	Glucocorticoid Effect	Patients with a new diagnosis of rheumatoid arthritis and indication for initiating DMARD treatment with a bridging of oral glucocorticoid treatment. Women should be postmenopausal and men older than 50 years.
IM	Glucocorticoid Effect	Patients with an inflammatory joint disease on stable DMARD treatment weith indication of intramuscular glucocorticoid injection. Women should be premenopausal and men younger than 50 years.

Primary Outcome Measures

Name	Time	Method
P1NP level 3 months after glucocorticoid termination	september 2024 til december 2025	P1NP in a blood sample

Secondary Outcome Measures

Name	Time	Method
CTX1 level 3 and 6 months after glucocorticoid termination	september 2024 til december 2025	CTX1 in a blood sample
P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids	september 2024 til december 2025	P1NP and CTX1 in a blood sample
P1NP level 6 months after glucocorticoid termination	september 2024 til december 2025	P1NP in a blood sample