Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
Overview
- Phase
- Not Applicable
- Intervention
- Glucocorticoid Effect
- Conditions
- Osteoporosis
- Sponsor
- Diakonhjemmet Hospital
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- P1NP level 3 months after glucocorticoid termination
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
RApre
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.
Intervention: Glucocorticoid Effect
RApost
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.
Intervention: Glucocorticoid Effect
IA
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.
Intervention: Glucocorticoid Effect
IM
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.
Intervention: Glucocorticoid Effect
Outcomes
Primary Outcomes
P1NP level 3 months after glucocorticoid termination
Time Frame: september 2024 til december 2025
P1NP in a blood sample
Secondary Outcomes
- CTX1 level 3 and 6 months after glucocorticoid termination(september 2024 til december 2025)
- P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids(september 2024 til december 2025)
- P1NP level 6 months after glucocorticoid termination(september 2024 til december 2025)