Immunophenotyping in Patients With Osteoporosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunological markers.
- Who it may be relevant to
- Registry conditions: Immunophenotyping Blood Samples of Patients With Osteoporosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Immunological markers
Markers of blood samples of patients suffering from osteoporosis will be analyzed
Primary outcome measures
- Immunological Marker [Time frame: 2 hours]
- DXA Values [Time frame: 30 minutes]
Secondary outcome measures (3)
- Secondary Osteoporosis [Time frame: 5 Minutes]
- Menstruation [Time frame: 2 Minutes]
- Anthropometric Data [Time frame: 3 Minutes]
Eligibility criteria
Inclusion criteria
- Adult patients (≥ 18 years) diagnosed with osteoporosis.
- Written informed consent from the patient
Exclusion criteria
- Patients without diagnosed osteoporosis
- Patients without written informed consent
- Patients < 18 years old
- Patients with secondary osteoporosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital of Bonn — Bonn
Identifiers
NCT: NCT05132348 · IPO15102021