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| Name | Class |
|---|---|
| Vestre Viken Hospital Trust | OTHER |
| Hormone Laboratory, Aker University Hospital, Oslo, Norway | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| P1NP level 3 months after glucocorticoid termination | P1NP in a blood sample | september 2024 til december 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| P1NP level 6 months after glucocorticoid termination | P1NP in a blood sample | september 2024 til december 2025 |
| CTX1 level 3 and 6 months after glucocorticoid termination | CTX1 in a blood sample |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of rheumatoid arthritis or spondyloarthritis or psoriatic arthritis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgitte Nellemann Nellemann, MD PHD | Contact | +4747957020 | birgittenellemann@gmail.com | |
| Tove T Borgen, MD PHD | Contact | +4795933386 | tove.tveitan.borgen@vestreviken.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken HF, Drammen | Recruiting | Drammen | 3024 | Norway | ||
| Diakonhjemmet hospital |
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| 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. |
|
| september 2024 til december 2025 |
| P1NP and CTX1 dynamic until 6 months after treatment of inflammation without glucocorticoids | P1NP and CTX1 in a blood sample | september 2024 til december 2025 |
| Recruiting |
| Oslo |
| 0319 |
| Norway |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D012213 | Rheumatic Fever |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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