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

  • STATUS
    Recruiting
  • End date
    Jul 5, 2029
  • participants needed
    10000
  • sponsor
    Prof Dr Frank Buttgereit
Updated on 5 February 2021
immunosuppressive
psoriasis
glucocorticoids
osteoporosis
immunosuppressants
arthritis
rheumatic diseases
glucocorticoid therapy

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.

Description

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.

Details
Condition Osteopenia, Osteopenia, Rheumatism, Rheumatic Fever, Rheumatic Fever, Osteoporosis, Osteoporosis, CONNECTIVE TISSUE DISEASE, Connective Tissue Diseases, Dermatomyositis (Connective Tissue Disease), Arthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), Arthritis and Arthritic Pain, Dermatomyositis (Connective Tissue Disease), Arthritis and Arthritic Pain (Pediatric), Connective Tissue Diseases, rheumatic disease, inflammatory rheumatism, collagen disorders, inflammatory rheumatisms
Treatment Glucocorticoid treatment
Clinical Study IdentifierNCT02719314
SponsorProf Dr Frank Buttgereit
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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 Charit 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
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