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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-90
SponsorDiakonhjemmet Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Glucocorticoid Effect

    Drug

    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.

Treatment groups

160 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: RApre1 intervention
Group B: RApost1 intervention
Group C: SpA0 interventions
Group D: PsA0 interventions
Group E: IA1 intervention
Group F: IM1 intervention

Trial outcomes

Primary outcomes

1

P1NP level 3 months after glucocorticoid termination

P1NP in a blood sample

Time frame
september 2024 til december 2025

Secondary outcomes

1

P1NP level 6 months after glucocorticoid termination

P1NP in a blood sample

Time frame
september 2024 til december 2025
2

CTX1 level 3 and 6 months after glucocorticoid termination

CTX1 in a blood sample

Time frame
september 2024 til december 2025
3

P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids

P1NP and CTX1 in a blood sample

Time frame
september 2024 til december 2025

Other outcomes

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