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

Osteoporosis Clinical Trial

— Rh-GIOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02719314
• Other study ID #: EA1/367/14
• Status: Recruiting
• Start date: December 2015
• Est. completion date: July 2029

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: Frank Buttgereit, Prof Dr
• Phone: +49 30 450 513125
• Email: frank.buttgereit[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 2029
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Inflammatory Rheumatism
• Osteoporosis
• Psoriasis
• Rheumatic Diseases
• Rheumatic Fever

Intervention

Drug:
• Glucocorticoid treatment
Glucocorticoid treatment

Locations

Country	Name	City	State
Germany	Charité University Medicine Berlin (CCM)	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Prof Dr Frank Buttgereit

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Buttgereit F. Views on glucocorticoid therapy in rheumatology: the age of convergence. Nat Rev Rheumatol. 2020 Apr;16(4):239-246. doi: 10.1038/s41584-020-0370-z. Epub 2020 Feb 19. — View Citation

Strehl C, Bijlsma JW, de Wit M, Boers M, Caeyers N, Cutolo M, Dasgupta B, Dixon WG, Geenen R, Huizinga TW, Kent A, de Thurah AL, Listing J, Mariette X, Ray DW, Scherer HU, Seror R, Spies CM, Tarp S, Wiek D, Winthrop KL, Buttgereit F. Defining conditions where long-term glucocorticoid treatment has an acceptably low level of harm to facilitate implementation of existing recommendations: viewpoints from an EULAR task force. Ann Rheum Dis. 2016 Jun;75(6):952-7. doi: 10.1136/annrheumdis-2015-208916. Epub 2016 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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