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

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

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, whichmin 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoporosis; Inflammatory Rheumatism; Osteoporosis, Steroid Induced
• Intervention / Treatment: Drug: Glucocorticoid Effect

• Study Type: Observational
• Enrollment (Estimated): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P1NP level 3 months after glucocorticoid termination	P1NP in a blood sample	august 2024 til december 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P1NP level 6 months after glucocorticoid termination	P1NP in a blood sample	august 2024 til december 2025
CTX1 level 3 and 6 months after glucocorticoid termination	CTX1 in a blood sample	august 2024 til december 2025
P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids	P1NP and CTX1 in a blood sample	august 2024 til december 2025

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: Vestre Viken Hospital Trust; Hormone Laboratory, Aker University Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Glucocorticoids; Bone turnover; Bone turnover markers
• Additional Relevant MeSH Terms: Metabolic Diseases; Infections; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Bone Diseases; Bone Diseases, Metabolic; Joint Diseases; Rheumatic Diseases; Osteoporosis; Rheumatic Fever; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucocorticoids
• Other Study ID Numbers: DS-00846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No