Actively Recruiting

Age: 18Years +
All Genders
ID02719314

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

Led by Prof Dr Frank Buttgereit · Updated on 2025-02-13

10000

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying glucocorticoid-induced osteoporosis (GIOP) in patients with chronic inflammatory rheumatic diseases or psoriasis. Glucocorticoids are commonly used to treat these conditions but can cause unwanted side effects, especially when used at higher doses for long periods. The study aims to collect and analyze detailed disease- and bone-related data to better understand the frequency and severity of GIOP, an area where current knowledge and scientific data are limited or outdated. This observational trial involves patients with or without chronic inflammatory rheumatic diseases or psoriasis who may have received or are expected to receive glucocorticoid therapy. Participants attend outpatient clinics for diagnosis, treatment, or follow-up of osteoporosis and bone metabolism according to current guidelines. Data from more than 1000 patients will be documented prospectively over the first three years, including those treated with glucocorticoids and control groups without such treatment. Participants will undergo clinical, laboratory, and instrumental examinations to collect information on bone mineral density and glucocorticoid usage, including dosage and duration. Researchers will monitor these outcomes over periods ranging from days to years. The study collects data from routine consultations and referrals, focusing on osteoporosis diagnosis, treatment, and follow-up. Participation involves consenting to data collection and storage, with ongoing assessment throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a diagnosis of chronic inflammatory rheumatic disease or psoriasis, or control patients without these conditions
  • Patients who have had or expect to start long-term glucocorticoid therapy (not applicable for control group)
  • Patients attending osteoporosis and bone metabolism outpatient consultation hours or referred for diagnosis, treatment, or follow-up
  • Ability to understand the patient information
  • Consent to participate in the project and data storage
Not Eligible

You will not qualify if you...

  • Alcohol, medication, or drug addiction
  • Severe psychiatric diseases that limit understanding or ability to consent
  • Pregnant or lactating patients
  • Patients unable to give informed consent for any reason
  • Prisoners or persons committed by official or judicial order

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 25 years

Participants who undergo routine care are observed to collect clinical, laboratory, and instrumental examination results related to glucocorticoid-induced osteoporosis.

Visits according to routine osteoporosis and bone metabolism outpatient consultations

Trial Site Locations

Total: 1 location

1

Charité University Medicine Berlin (CCM)

Berlin, Germany, 10117

Actively Recruiting

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Research Team

F

Frank Buttgereit, Prof Dr

E

Edgar Wiebe, Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

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.

Cindy Strehl, Johannes W J Bijlsma, Maarten de Wit...

https://pubmed.ncbi.nlm.nih.gov/26933146

Sex and age do not modify the association between glucocorticoids and bone mineral density in patients with rheumatoid arthritis: a cross-sectional study.

Andriko Palmowski, Zhivana Boyadzhieva, Sabrina M Nielsen...

https://pubmed.ncbi.nlm.nih.gov/37287080

Optimising both disease control and glucocorticoid dosing is essential for bone protection in patients with rheumatic disease.

Edgar Wiebe, Dörte Huscher, Désireé Schaumburg...

https://pubmed.ncbi.nlm.nih.gov/35680387