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临床试验/NCT02719314
NCT02719314招募中不适用

Non-interventional Clinical Trial to Establish a Glucocorticoid-induced Osteoporosis Databank for Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis and Therapy With Glucocorticoids

Prof Dr Frank Buttgereit1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Bone mineral density

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Rh-GIOP(A)

Glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases

干预措施: Glucocorticoid treatment (Drug)

Rh-GIOP(B)

Glucocorticoid-induced osteoporosis (GIOP) in the context of psoriasis

干预措施: Glucocorticoid treatment (Drug)

结局指标

主要结局

Bone mineral density

时间窗: 2 - 5 years

T-score (measured by DEXA; statistical evaluation on group levels, lower values are considered as being more dangerous)

次要结局

  • Mean daily glucocorticoid dosage(1 day - 25 years)
  • Cumulative glucocorticoid dosage(at least 1 day - 25 years)
  • Duration of glucocorticoid dosage(from 1 day - 25 years)

研究者

发起方
Prof Dr Frank Buttgereit
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof Dr Frank Buttgereit

Prof Dr

Charite University, Berlin, Germany

研究点 (1)

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