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

NCT06395883 | Recruiting

• 1 other identifier: DS-00846
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoporosis; Osteoporosis, Steroid Induced; Inflammatory Rheumatism

Keywords

Bone turnover; Bone turnover markers; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• P1NP level 3 months after glucocorticoid termination

  P1NP in a blood sample

  september 2024 til december 2025

Secondary Outcomes (3)

• P1NP level 6 months after glucocorticoid termination

  september 2024 til december 2025

• CTX1 level 3 and 6 months after glucocorticoid termination

  september 2024 til december 2025

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

  september 2024 til december 2025

Study Arms (6)

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

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.

IA; IM; RApost; RApre

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• known osteoporosis or osteoporosis treatment
• women during the transitory phase
• oestrogen treatment
• any fracture within the last year
• chronic glucocorticoid treatment
• active cancer
• kidney failure

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• Vestre Viken Hospital Trust: collaborator
• Hormone Laboratory, Aker University Hospital, Oslo, Norway: collaborator

Study Sites (2)

Vestre Viken HF, Drammen

Drammen, 3024, Norway

RECRUITING

Diakonhjemmet hospital

Oslo, 0319, Norway

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Rheumatic Fever

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Birgitte Nellemann Nellemann, MD PHD

CONTACT

+4747957020; birgittenellemann@gmail.com

Tove T Borgen, MD PHD

CONTACT

+4795933386; tove.tveitan.borgen@vestreviken.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)