Inflammatory Rheumatism, Osteoporosis, Osteoporosis, Steroid Induced
Conditions
Keywords
Bone turnover, Bone turnover markers, Glucocorticoids
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.
Interventions
DRUGGlucocorticoid 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.
Sponsors
Diakonhjemmet Hospital
Vestre Viken Hospital Trust
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P1NP level 3 months after glucocorticoid termination | september 2024 til december 2025 | P1NP in a blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Contacts
CONTACTBirgitte Nellemann Nellemann, MD PHD
CONTACTTove T Borgen, MD PHD
Outcome results
None listed