About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of inflammatory rheumatic joint disease
indication of disease modifying treatment initiation with or without glucocorticoids OR
stable DMARD treatment with parenteral glucocorticoid injection
Disqualifiers
known osteoporosis or osteoporosis treatment
women during the transitory phase
oestrogen treatment
any fracture within the last year
Trial population
Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis
Trial design
Case-only
Prospective
Treatments tested in this trial
Glucocorticoid Effect
DrugPatients 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.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
P1NP level 3 months after glucocorticoid termination
P1NP in a blood sample
Secondary outcomes
P1NP level 6 months after glucocorticoid termination
P1NP in a blood sample
CTX1 level 3 and 6 months after glucocorticoid termination
CTX1 in a blood sample
P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids
P1NP and CTX1 in a blood sample
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Diakonhjemmet Hospital
Lead sponsor
Vestre Viken Hospital Trust
Collaborator
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Collaborator