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RecruitingNCT06395883BOOGIEUpdated Aug 19, 2026

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

An observational study in Osteoporosis, Osteoporosis, Steroid Induced and Inflammatory Rheumatism, sponsored by Diakonhjemmet Hospital. Recruiting at 2 sites in Norway. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Diakonhjemmet Hospital · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
160
Ages
25 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoporosis
  • Osteoporosis, Steroid Induced
  • Inflammatory Rheumatism

Keywords

  • Bone turnover
  • Bone turnover markers
  • Glucocorticoids
03

In context

Osteoporosis

1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.

This study's planned enrollment of 160 is close to the median of 160 across 455 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of inflammatory rheumatic joint disease
  • indication of disease modifying treatment initiation with or without OR
  • stable DMARD treatment with parenteral glucocorticoid injection

Exclusion criteria

Exclusion Criteria:

  • known osteoporosis or osteoporosis treatment
  • women during the transitory phase
  • oestrogen treatment
  • any fracture within the last year
  • chronic treatment
  • glucocorticoid treatment within the last year prior to inclusion
  • active cancer
  • kidney failure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • RApre

    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.

    Drug: Glucocorticoid Effect

  • RApost

    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.

    Drug: Glucocorticoid Effect

  • SpA

    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

    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

    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.

    Drug: Glucocorticoid Effect

  • IM

    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.

    Drug: Glucocorticoid Effect

Interventions

  • 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.

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Oct 2027, 33 months after the start.

Of 114 non-industry observational studies under Osteoporosis, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 113. This study's planned 33 months is below that.

Counting every sponsor, half of 125 studies reached it within 51 months; a quarter within 24 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2024
First posted
May 2, 2024
StartActual
Jan 1, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Dec 2028
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395883
Lead sponsor
Diakonhjemmet Hospital
Collaborators
Vestre Viken Hospital Trust, Hormone Laboratory, Aker University Hospital, Oslo, Norway
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Jan 1, 2025
Primary completion
Oct 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 19, 2026

Study contacts

Birgitte Nellemann Nellemann, MD PHD
Contact
birgittenellemann@gmail.com
+4747957020
Tove T Borgen, MD PHD
Contact
tove.tveitan.borgen@vestreviken.no
+4795933386

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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