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

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

Study Description
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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.

Condition or disease Intervention/treatment
Osteoporosis Inflammatory Rheumatism Drug: Glucocorticoid treatment

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Years
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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Rh-GIOP(A)
Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases
 Drug: Glucocorticoid treatment
Glucocorticoid treatment
Other Name: prednis(ol)one, methylprednisolone
Rh-GIOP(B)
Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis
 Drug: Glucocorticoid treatment
Glucocorticoid treatment
Other Name: prednis(ol)one, methylprednisolone
Rh-GIOP(C)
Patients with or without chronic/inflammatory rheumatic diseases or psoriasis and/or without glucocorticoid treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic inflammatory rheumatic diseases or psoriasis treated with glucocorticoids
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719314


Contacts
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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

Locations
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Germany
Charité University Medicine Berlin (CCM) Recruiting
Berlin, Germany, 10117
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   
Sponsors and Collaborators
Prof Dr Frank Buttgereit
Investigators
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Principal Investigator: Frank Buttgereit, Prof Dr Charité University Medicine Berlin (CCM)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof Dr Frank Buttgereit, Prof Dr, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02719314    
Other Study ID Numbers: EA1/367/14
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Fever
Osteoporosis
Rheumatic Diseases
Psoriasis
Collagen Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Arthritis
Joint Diseases
Methylprednisolone
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents