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临床试验/NCT05132348
NCT05132348招募中不适用

Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Immunological Marker

研究概览

简要总结

In addition to a medical history and clinical examination, the diagnosis of osteoporosis includes the measurement of bone surface density by means of dual X-ray absorptiometry (DXA). In addition, blood tests are performed for certain parameters, such as vitamin D, calcium, phosphate and C-reactive protein. In order to optimize osteoporosis diagnostics, the development of further specific methods is required. The modulation of the immune system seems promising in this respect, since osteoporosis is based on an inflammatory reaction. Various regulatory markers of the innate and acquired immune system, which seem to be relevant in the development of the disease, have already been detected in osteoporosis patients. This study may help to gain new insights into disease-associated immunoregulatory markers that could revolutionize both the diagnosis and therapy of osteoporosis in the long term. By means of a simple blood test, patients could be diagnosed early and without additional radiation exposure, and effective therapy options could be developed.

详细描述

Osteoporosis is a disease of bone metabolism. The underlying disturbance of bone homeostasis promotes bone fractures and, in advanced stages, especially spontaneous fractures. The diagnosis of osteoporosis is carried out as part of routine clinical practice. In addition to the patient's medical history and clinical examination, blood tests are also carried out on certain parameters, including the concentrations of vitamin D, calcium and phosphate as well as C-reactive protein. In addition, bone density is measured by dual X-ray absorptiometry (DXA). The results can be used to determine the degree of osteoporosis, which affects the further therapeutic approach.

Therapy is essentially based on fracture prevention through optimization of dietary habits, promotion of physical activity, and adequate vitamin D intake. Pharmacological options mainly do not counteract the pathological bone loss and are usually not tolerable due to serious side effects or are only approved for a limited period of use. Consequently, the development of further options to complement existing methods is required for the diagnosis and treatment of osteoporosis. The modulation of the immune system seems to be promising, since osteoporosis is based on an inflammatory reaction. Thus, various regulatory markers of the innate and acquired immune system, which seem to be relevant in the development of the disease, have already been detected in osteoporosis patients. However, central questions regarding the immune phenotype of affected individuals remain unanswered. For example, it is unclear to what extent certain molecules, mostly growth factors or chemokines, influence the inflammatory processes in the context of osteoporosis. Furthermore, it is controversial whether and, if so, how immune markers influence each other and what effects this has on bone metabolism.In the long term, new insights regarding the properties of disease-associated immunoregulatory markers could revolutionize the diagnostic possibilities for osteoporosis, as affected individuals could be identified early and without additional radiation exposure by simple blood tests. Equally relevant is corresponding information for the improvement of therapy. In the future, the causative immune processes could be treated by regulating the corresponding immunological markers and meaningfully expand existing therapy options.

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

  • Adult patients (≥ 18 years) diagnosed with osteoporosis.
  • Written informed consent from the patient

排除标准

  • Patients without diagnosed osteoporosis
  • Patients without written informed consent
  • Patients < 18 years old
  • Patients with secondary osteoporosis

结局指标

主要结局

Immunological Marker

时间窗: 2 hours

Standardized values for the diagnosis of osteoporosis are examined in the blood samples taken. In addition, one serum sample and one EDTA sample (S-Monofat, Sarstedt AG \& Co. KG, Nümbrecht, Germany, 7.5 ml each) are taken in order to analyze the immunophenotype on the cellular level as well as on the basis of soluble markers. Following the puncture, these samples are processed in the research laboratory of the Clinic for Orthopedics and Trauma Surgery and examined using various immunoassays.

DXA Values

时间窗: 30 minutes

Measurement of bone surface density using DXA scans

次要结局

  • Secondary Osteoporosis(5 Minutes)
  • Menstruation(2 Minutes)
  • Anthropometric Data(3 Minutes)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. Andreas Strauß

PD. Dr. med.

University Hospital, Bonn

研究点 (1)

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