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

NCT02719314 | Recruiting

• 1 other identifier: EA1/367/14
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Inflammatory Rheumatism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean daily glucocorticoid dosage

  1 day - 25 years

• Cumulative glucocorticoid dosage

  at least 1 day - 25 years

• Duration of glucocorticoid dosage

  from 1 day - 25 years

Study Arms (3)

Rh-GIOP(A)

Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases

Drug: Glucocorticoid treatment

Rh-GIOP(B)

Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis

Drug: Glucocorticoid treatment

Rh-GIOP(C)

Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment

Interventions

Glucocorticoid treatment DRUG

Glucocorticoid treatment

Also known as: prednis(ol)one, methylprednisolone

Rh-GIOP(A); Rh-GIOP(B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof Dr Frank Buttgereit: lead

Study Sites (1)

Charité University Medicine Berlin (CCM)

Berlin, 10117, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 26933146 BACKGROUND

• 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.

  PMID: 32076129 BACKGROUND

• Palmowski A, Boyadzhieva Z, Nielsen SM, Muche B, Hermann S, Boers M, Bliddal H, Christensen R, Wiebe E, Buttgereit F. Sex and age do not modify the association between glucocorticoids and bone mineral density in patients with rheumatoid arthritis: a cross-sectional study. Arthritis Res Ther. 2023 Jun 7;25(1):98. doi: 10.1186/s13075-023-03083-x.

  PMID: 37287080 DERIVED

• 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 Aug 11;81(9):1313-1322. doi: 10.1136/annrheumdis-2022-222339.

  PMID: 35680387 DERIVED

MeSH Terms

Conditions

Osteoporosis; Rheumatic Fever

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Frank Buttgereit, Prof Dr

  Charité University Medicine Berlin (CCM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Buttgereit, Prof Dr

CONTACT

+49 30 450 513125; frank.buttgereit@charite.de

Edgar Wiebe, Dr

CONTACT

+49 30 450 513192; gerd.burmester@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: March 25, 2016
• Study Start: December 1, 2015
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)