About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids
Trial design
Cohort
Prospective
Treatments tested in this trial
Glucocorticoid treatment
DrugGlucocorticoid treatment
Treatment groups
Trial outcomes
Primary outcomes
Bone mineral density
T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous)
Secondary outcomes
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)
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)
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof Dr Frank Buttgereit
Lead sponsor
Charite University, Berlin, Germany
Sponsor institution