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Immunophenotyping in Patients With Osteoporosis

NCT ID: NCT05132348

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-10

Study Completion Date

2026-10-19

Brief Summary

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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

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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.

Conditions

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Immunophenotyping Blood Samples of Patients With Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Immunological markers

Markers of blood samples of patients suffering from osteoporosis will be analyzed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Andreas Strauß

PD. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Strauß, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

physican

Locations

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University Hospital of Bonn

Bonn, Northrhine Westfalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Strauß, PD Dr.

Role: CONTACT

Phone: 004922828714176

Email: [email protected]

Facility Contacts

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Andreas Strauß, PD Dr.

Role: primary

Other Identifiers

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IPO15102021

Identifier Type: -

Identifier Source: org_study_id