Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis (Rh-GIOP)

• ClinicalTrials.gov Identifier: NCT02719314
• Recruitment Status: Recruiting
• First Posted: March 25, 2016
• Last Update Posted: March 9, 2022
• Sponsor: Prof Dr Frank Buttgereit
• Information provided by (Responsible Party): Prof Dr Frank Buttgereit, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: March 21, 2016
• First Posted Date: March 25, 2016
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: December 2015
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2018)

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)

• Original Primary Outcome Measures (submitted: March 21, 2016): Bone mineral density [ Time Frame: 2 - 5 years ]

Current Secondary Outcome Measures (submitted: September 6, 2018)

• Mean daily glucocorticoid dosage [ Time Frame: 1 day - 25 years ]
  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)
• Cumulative glucocorticoid dosage [ Time Frame: at least 1 day - 25 years ]
  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)
• Duration of glucocorticoid dosage [ Time Frame: from 1 day - 25 years ]
  Duration of glucocorticoid therapy in days (measured by questionnaire; statistical evaluation on group levels; higher values are considered as being more dangerous)

• Original Secondary Outcome Measures (submitted: March 21, 2016): glucocorticoid dosage [ Time Frame: 2 - 5 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
• 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
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 14 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids

Condition

• Osteoporosis
• Inflammatory Rheumatism

Intervention

Drug: Glucocorticoid treatment

Glucocorticoid treatment

Other Name: prednis(ol)one, methylprednisolone

Study Groups/Cohorts

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

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.
• Buttgereit 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.
• Wiebe 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 Jun 9;81(9):1313-22. doi: 10.1136/annrheumdis-2022-222339. Online ahead of print.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 21, 2016): 10000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2029
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Frank Buttgereit, Prof Dr; +49 30 450 513125; frank.buttgereit@charite.de

Contact: Gerd-Rüdiger Burmester, Prof Dr; +49 30 450 513192; gerd.burmester@charite.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02719314
• Other Study ID Numbers: EA1/367/14
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Prof Dr Frank Buttgereit, Charite University, Berlin, Germany
• Original Responsible Party: Same as current
• Current Study Sponsor: Prof Dr Frank Buttgereit
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frank Buttgereit, Prof Dr; Charité University Medicine Berlin (CCM)

• PRS Account: Charite University, Berlin, Germany
• Verification Date: March 2022