NCT02719314 Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
| NCT ID | NCT02719314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof Dr Frank Buttgereit |
| Condition | Osteoporosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2015-12 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2015-12 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frank Buttgereit, Prof Dr
PRINCIPAL INVESTIGATOR
Charité University Medicine Berlin (CCM)
Frequently Asked Questions
Who can join the NCT02719314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02719314 currently recruiting?
Yes, NCT02719314 is actively recruiting participants. Contact the research team at frank.buttgereit@charite.de for enrollment information.
Where is the NCT02719314 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT02719314 clinical trial?
NCT02719314 is sponsored by Prof Dr Frank Buttgereit. The principal investigator is Frank Buttgereit, Prof Dr at Charité University Medicine Berlin (CCM). The trial plans to enroll 10,000 participants.