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

Diakonhjemmet Hospital

Status: Not yet enrolling

Conditions: Osteoporosis; Osteoporosis, Steroid Induced; Inflammatory Rheumatism

Treatments: Drug: Glucocorticoid Effect

Study type: Observational

Funder types: Other

Identifiers

NCT06395883

DS-00846

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 25 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 6 patient groups

RApre

Description:

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.

Treatment:

Drug: Glucocorticoid Effect

RApost

Description:

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.

Treatment:

Drug: Glucocorticoid Effect

SpA

Description:

Patients with a new diagnosis of spondyloarthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years.

PsA

Description:

Patients with a new diagnosis of psoriatic arthritis and indication of DMARD treatment without glucocorticoid treatment. Women should be premenopausal and men younger than 50 years.

IA

Description:

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.

Treatment:

Drug: Glucocorticoid Effect

IM

Description:

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.

Treatment:

Drug: Glucocorticoid Effect