Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis

Study Overview
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Brief Summary
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Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time. The available data describing frequency and severity of these adverse effects are fragmentary. This statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific data, being sparse, is partly conflicting and often derived from over-aged projects or studies. Therefore, there are urgent needs to work on various current questions systematically and at the highest scientific level possible. In order to address these needs, we aim at collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental examination results from more than 1000 patients in the first three years of the project are planned to be documented in a prospective database.

Detailed Description
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Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time. The available data describing frequency and severity of these adverse effects are fragmentary. This statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis), since GIOP is counted among the two most important adverse effects of glucocorticoid therapy, by both rheumatologists and patients. The state of knowledge and scientific data, being sparse, is partly conflicting and often derived from over-aged projects or studies. Therefore, there are urgent needs to work on various current questions systematically and at the highest scientific level possible. In order to address these needs, we aim at collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental examination results from more than 1000 patients in the first three years of the project are planned to be documented in a prospective database.

Official Title
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Non-interventional Clinical Trial to Establish a Glucocorticoid-induced Osteoporosis Databank for Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis and Therapy With Glucocorticoids

Conditions
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Osteoporosis, Inflammatory Rheumatism

Intervention / Treatment
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* Drug: Glucocorticoid treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every patient has to fulfill the following inclusion criteria: patients with (control group: without) a diagnosis of a chronic inflammatory rheumatic disease or psoriasis patients who (not for control groups) have/had already a glucocorticoid therapy, or patients in which the implementation of a new long-term GC therapy is expected patients who, according to the Dachverband Osteologie (DVO, Germany) guidelines, attend our osteoporosis and bone metabolism outpatient consultation hours or are referred by the hospital wards of the Charité for diagnosis, treatment or follow-up capability to understand the patient information consent to participation in the project and storage of data Exclusion Criteria: If any of the following exclusion criteria is true, the patient must not be included in this study: alcohol, medication and/or drug addiction severe psychiatric diseases limiting the comprehension of the project plan and the study protocol (persons incapable of giving informed consent) pregnant and lactating patients patients incapable of giving informed consent for any reason prisoners and all persons who are committed to an institution due to an official or judicial order

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rh-GIOP(A)<br>Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases | Drug: Glucocorticoid treatment<br>* Glucocorticoid treatment<br>* Other names: prednis(ol)one, methylprednisolone;|
| Rh-GIOP(B)<br>Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis | Drug: Glucocorticoid treatment<br>* Glucocorticoid treatment<br>* Other names: prednis(ol)one, methylprednisolone;|
| Rh-GIOP(C)<br>Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous) | 2 - 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily glucocorticoid dosage | Mean daily dosage in milligram prednisone equivalent per day (measured by questionnaire; averaged values are calculated; statistical evaluation on group levels, higher values are considered as being more dangerous) | 1 day - 25 years | 
| Cumulative glucocorticoid dosage | Cumulative glucocorticoid dosage in gram (measured by questionnaire; summed values are calculated; statistical evaluation on group levels, higher values are considered as being more dangerous) | at least 1 day - 25 years | 
| Duration of glucocorticoid dosage | Duration of glucocorticoid therapy in days (measured by questionnaire; statistical evaluation on group levels; higher values are considered as being more dangerous) | from 1 day - 25 years |