Clinical trial NCT05132348: Immunophenotyping in Patients With Osteoporosis
Official title: Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunophenotyping Blood Samples of Patients With Osteoporosis
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diagnosed osteoporosis will be analyzed in this study.

Brief summary: 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.

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

Primary outcomes:
measure: Immunological Marker
timeFrame: 2 hours
measure: DXA Values
timeFrame: 30 minutes
Secondary outcomes:
measure: Secondary Osteoporosis
timeFrame: 5 Minutes
measure: Menstruation
timeFrame: 2 Minutes
measure: Anthropometric Data
timeFrame: 3 Minutes
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital of Bonn
state: Northrhine Westfalia
Study officials:
affiliation: physican
name: Andreas Strauß, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: