Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis (Rh-GIOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis; Inflammatory Rheumatism
• Intervention / Treatment: Drug: Glucocorticoid treatment

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Frank Buttgereit, Prof Dr; Phone Number: +49 30 450 513125; Email: frank.buttgereit@charite.de
• Study Contact Backup: Name: Edgar Wiebe, Dr; Phone Number: +49 30 450 513192; Email: gerd.burmester@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité University Medicine Berlin (CCM)
    • Contact: Frank Buttgereit, Prof Dr; Phone Number: +49 30 450 513125; Email: frank.buttgereit@charite.de
    • Contact: Gerd-Rüdiger Burmester, Prof Dr; Phone Number: +49 30 450 513192; Email: gerd.burmester@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prof Dr Frank Buttgereit
• Investigators: Principal Investigator: Frank Buttgereit, Prof Dr, Charité University Medicine Berlin (CCM)

Publications and helpful links

General Publications

• 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.
• 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.
• Wiebe E, Huscher D, Schaumburg D, Palmowski A, Hermann S, Buttgereit T, Biesen R, Burmester GR, Palmowski Y, Boers M, Stone JH, Dejaco C, Buttgereit F. Optimising both disease control and glucocorticoid dosing is essential for bone protection in patients with rheumatic disease. Ann Rheum Dis. 2022 Jun 9;81(9):1313-22. doi: 10.1136/annrheumdis-2022-222339. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Papulosquamous; Bone Diseases; Bone Diseases, Metabolic; Psoriasis; Rheumatic Diseases; Collagen Diseases; Osteoporosis; Rheumatic Fever; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Methylprednisolone; Glucocorticoids
• Other Study ID Numbers: EA1/367/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No