Osteoporosis Clinical Trial
— BOOGIEOfficial title:
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study
NCT number | NCT06395883 |
Other study ID # | DS-00846 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2024 |
Est. completion date | June 2028 |
Verified date | April 2024 |
Source | Diakonhjemmet Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Diakonhjemmet Hospital | Hormone Laboratory, Aker University Hospital, Oslo, Norway, Vestre Viken Hospital Trust |
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 |
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