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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Germany
Charité University Medicine Berlin (CCM)
RECRUITING
Berlin
Contact Information
Primary
Frank Buttgereit, Prof Dr
frank.buttgereit@charite.de
+49 30 450 513125
Backup
Edgar Wiebe, Dr
gerd.burmester@charite.de
+49 30 450 513192
Time Frame
Start Date: 2015-12
Estimated Completion Date: 2029-07
Participants
Target number of participants: 10000
Treatments
Rh-GIOP(A)
Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases
Rh-GIOP(B)
Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis
Rh-GIOP(C)
Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment
Sponsors
Leads: Prof Dr Frank Buttgereit

This content was sourced from clinicaltrials.gov