Understanding osteoporosis caused by glucocorticoids in patients with chronic inflammatory diseases or psoriasis
Non-interventional Clinical Trial to Establish a Glucocorticoid-induced Osteoporosis Databank for Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis and Therapy With Glucocorticoids
This study is trying to gather information on osteoporosis caused by glucocorticoid treatment in people with chronic inflammatory diseases or psoriasis to better understand and manage this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT02719314 on ClinicalTrials.gov |
What this trial studies
This study aims to systematically collect and analyze data related to glucocorticoid-induced osteoporosis (GIOP) in patients suffering from chronic inflammatory rheumatic diseases or psoriasis. By gathering clinical, laboratory, and instrumental examination results from over 1000 patients, the research seeks to build a comprehensive GIOP databank. The study will also involve diagnostics and follow-up care for GIOP according to current guidelines, addressing the urgent need for more robust data on this adverse effect of glucocorticoid therapy.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic inflammatory rheumatic diseases or psoriasis who are currently undergoing or expected to start glucocorticoid therapy.
Not a fit: Patients with severe psychiatric diseases or substance addictions that limit their comprehension of the study may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of osteoporosis in patients undergoing glucocorticoid treatment.
How similar studies have performed: While there is limited data on GIOP in this specific context, similar studies have highlighted the need for more comprehensive research on glucocorticoid side effects, indicating a gap that this study aims to fill.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin
- Charité University Medicine Berlin (CCM) — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Frank Buttgereit, Prof Dr — Charité University Medicine Berlin (CCM)
- Study coordinator: Frank Buttgereit, Prof Dr
- Email: frank.buttgereit@charite.de
- Phone: +49 30 450 513125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.