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

Osteoporosis Clinical Trial

— BOOGIE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395883
• Other study ID #: DS-00846
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Rheumatism
• Joint Diseases
• Osteoporosis
• Osteoporosis, Steroid Induced
• Rheumatic Diseases
• Rheumatic Fever

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Hormone Laboratory, Aker University Hospital, Oslo, Norway, Vestre Viken Hospital Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P1NP level 3 months after glucocorticoid termination	P1NP in a blood sample	august 2024 til december 2025
Secondary	P1NP level 6 months after glucocorticoid termination	P1NP in a blood sample	august 2024 til december 2025
Secondary	CTX1 level 3 and 6 months after glucocorticoid termination	CTX1 in a blood sample	august 2024 til december 2025
Secondary	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