OsteoporosisRh-GIOPNCT02719314
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
An observational study of Osteoporosis and Inflammatory Rheumatism, run by Prof Dr Frank Buttgereit at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Inflammatory Rheumatism
- What is being tested?
- Glucocorticoid treatment
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Jul 2029
- How long will I take part?
- 14 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité University Medicine Berlin (CCM)
Berlin, 10117
Frank Buttgereit, Prof Dr, +49 30 450 513125, frank.buttgereit@charite.de
Gerd-Rüdiger Burmester, Prof Dr, +49 30 450 513192, gerd.burmester@charite.de
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Osteoporosis, Inflammatory Rheumatism
- Being tested
- Glucocorticoid treatment
- Medical subject headings
- Osteoporosis, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid treatmentDrug
Also called prednis(ol)one, methylprednisolone
Glucocorticoid treatment
| Study group | Role | What they receive |
|---|---|---|
| Rh-GIOP(A) | Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases Receives: Drug: Glucocorticoid treatment | |
| Rh-GIOP(B) | Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis Receives: Drug: Glucocorticoid treatment | |
| Rh-GIOP(C) | Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous)
Measured: 2 - 5 years
Secondary outcomes (3)
Mean daily glucocorticoid dosage
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)
Measured: 1 day - 25 years
Cumulative glucocorticoid dosage
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)
Measured: at least 1 day - 25 years
Duration of glucocorticoid dosage
Duration of glucocorticoid therapy in days (measured by questionnaire; statistical evaluation on group levels; higher values are considered as being more dangerous)
Measured: from 1 day - 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2025 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Prof Dr Frank Buttgereit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Dr Frank Buttgereit, Charite University, Berlin, Germany
- Investigators
- Frank Buttgereit, Prof Dr, Principal investigator, Charité University Medicine Berlin (CCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719314
- Sponsor's protocol ID
- EA1/367/14
- Acronym
- Rh-GIOP
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2016
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26933146Buttgereit 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.
PubMed 32076129Palmowski 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.
PubMed 37287080Wiebe 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.
PubMed 35680387
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02719314
- Acronym / sponsor ID
- Rh-GIOP / EA1/367/14
- Conditions
- Osteoporosis, Inflammatory Rheumatism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Prof Dr Frank ButtgereitUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rh-GIOP(A) | – | Drug: Glucocorticoid treatmentGlucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases |
| Rh-GIOP(B) | – | Drug: Glucocorticoid treatmentGlucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis |
| Rh-GIOP(C) | – | –Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucocorticoid treatmentAlso: prednis(ol)one, methylprednisoloneGlucocorticoid treatment | Drug | Rh-GIOP(A), Rh-GIOP(B) |
Primary outcome
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)
3 secondary outcomes
Mean daily glucocorticoid dosage
Time frame: 1 day - 25 years
Cumulative glucocorticoid dosage
Time frame: at least 1 day - 25 years
Duration of glucocorticoid dosage
Time frame: from 1 day - 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 26933146Strehl 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.
- Background: PubMed 32076129Buttgereit 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.
- Derived from this study: PubMed 37287080Palmowski 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.
- Derived from this study: PubMed 35680387Wiebe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Buttgereit, Prof Dr principal investigator
Charité University Medicine Berlin (CCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Inflammatory Rheumatism, run by Prof Dr Frank Buttgereit at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Buttgereit, Prof Dr (+49 30 450 513125, frank.buttgereit@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 2 - 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719314, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.