Glucocorticoid-induced Osteoporosis in Patients With Chro... | NCT02719314

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

NCT02719314

Sponsor

Prof Dr Frank Buttgereit

Status

Recruiting

Last Update Posted

Feb 13, 2025Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Osteoporosis
Inflammatory Rheumatism

Interventions

Glucocorticoid treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Jul 2029Estimated

First Submitted Date

Mar 21, 2016

First Submission Date that Met QC Criteria

Mar 21, 2016

First Posted Date

Mar 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

14 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Rh-GIOP(A)	Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases	Drug: Glucocorticoid treatment
Rh-GIOP(B)	Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis	Drug: Glucocorticoid treatment
Rh-GIOP(C)	Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucocorticoid treatment	Drug	Glucocorticoid treatment	Rh-GIOP(A) Rh-GIOP(B)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density	T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous)	2 - 5 years

Secondary Outcomes

Measure	Description	Time Frame
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)	1 day - 25 years
Cumulative glucocorticoid dosage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frank Buttgereit, Prof Dr	Contact	+49 30 450 513125		frank.buttgereit@charite.de
Edgar Wiebe, Dr	Contact	+49 30 450 513192		gerd.burmester@charite.de

Overall Officials

Name	Affiliation	Role
Frank Buttgereit, Prof Dr	Charité University Medicine Berlin (CCM)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité University Medicine Berlin (CCM)	Recruiting	Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26933146	Background	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.
32076129

ID	Term
D010024	Osteoporosis
D012213	Rheumatic Fever

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes