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NCT Number: NCT06395883

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

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.

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Key information

Conditions

Osteoporosis Arthritis Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Inflammatory Rheumatism Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis, Steroid Induced Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestre Viken HF, Drammen, Drammen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. P1NP level 3 months after glucocorticoid termination

    Time frame: september 2024 til december 2025

    P1NP in a blood sample

Secondary outcomes

  1. P1NP level 6 months after glucocorticoid termination

    Time frame: september 2024 til december 2025

    P1NP in a blood sample

  2. CTX1 level 3 and 6 months after glucocorticoid termination

    Time frame: september 2024 til december 2025

    CTX1 in a blood sample

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

    Time frame: september 2024 til december 2025

    P1NP and CTX1 in a blood sample

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitte Nellemann Nellemann, MD PHD

CONTACT

[email protected]

+4747957020

Tove T Borgen, MD PHD

CONTACT

[email protected]

+4795933386

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Hormone Laboratory, Aker University Hospital, Oslo, Norway
  • Vestre Viken Hospital Trust

Registry information

Official study title

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

Acronym: BOOGIE

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 2, 2024
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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