Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02719314

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucocorticoid treatment

Drug

Glucocorticoid treatment

Other names: prednis(ol)one, methylprednisolone

Primary outcomes

  1. Bone mineral density

    Time frame: 2 - 5 years

    T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous)

Secondary outcomes

  1. Mean daily glucocorticoid dosage

    Time frame: 1 day - 25 years

    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)

  2. Cumulative glucocorticoid dosage

    Time frame: at least 1 day - 25 years

    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)

  3. Duration of glucocorticoid dosage

    Time frame: from 1 day - 25 years

    Duration of glucocorticoid therapy in days (measured by questionnaire; statistical evaluation on group levels; higher values are considered as being more dangerous)

Study contacts

Contact information is provided by the study sponsor or research team.

Edgar Wiebe, Dr

CONTACT

[email protected]

+49 30 450 513192

Frank Buttgereit, Prof Dr

CONTACT

[email protected]

+49 30 450 513125

Sponsors and collaborators

Lead sponsor

Prof Dr Frank Buttgereit

Other

Registry information

Official study 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

Acronym: Rh-GIOP

Important dates

Study start
2015
Primary completion
2025
Study completion
2029
First posted
Mar 25, 2016
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.