Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glucocorticoid Effect.
- Who it may be relevant to
- Registry conditions: Osteoporosis, Osteoporosis, Steroid Induced, Inflammatory Rheumatism. Basic parameters: 25 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
Overview
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
- Drug Glucocorticoid 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.
Primary outcome measures
- P1NP level 3 months after glucocorticoid termination [Time frame: september 2024 til december 2025]
Secondary outcome measures (3)
- P1NP level 6 months after glucocorticoid termination [Time frame: september 2024 til december 2025]
- CTX1 level 3 and 6 months after glucocorticoid termination [Time frame: september 2024 til december 2025]
- P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids [Time frame: september 2024 til december 2025]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Norway · 2 centers
- Vestre Viken HF, Drammen — Drammen
- Diakonhjemmet hospital — Oslo
Identifiers
NCT: NCT06395883 · DS-00846