Immunophenotyping in Patients With Osteoporosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bonn
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥ 18 years) diagnosed with osteoporosis.
Written informed consent from the patient
Disqualifiers
Patients without diagnosed osteoporosis
Patients without written informed consent
Patients < 18 years old
Patients with secondary osteoporosis
Trial population
Adult patients with diagnosed osteoporosis will be analyzed in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Immunological markers
Diagnostic testMarkers of blood samples of patients suffering from osteoporosis will be analyzed
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Immunological Marker
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.
Time frame
2 hours2
DXA Values
Measurement of bone surface density using DXA scans
Time frame
30 minutesSecondary outcomes
1
Secondary Osteoporosis
In addition to the medical history and clinical examination, all patients included in the study will complete a questionnaire to exclude a secondary form of osteoporosis. Among other things, previous occurrence of (spontaneous) fractures of the patients as well as the family history with regard to other diseases and fractures will be asked. The questionnaire is based on the S3 guideline of the German Osteoporosis Organization.
Time frame
5 Minutes2
Menstruation
Patients are also asked whether the measurements take place at the time of their menstruation.
Time frame
2 Minutes3
Anthropometric Data
Assessment of weight in kilograms, height in meters and age in years in form of questionnaire. Weight and height will be combined to report BMI in kg/m\^2.
Time frame
3 MinutesSponsors and contacts
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Source ClinicalTrials.gov