Immunophenotyping Blood Samples of Patients With OsteoporosisIPONCT05132348
Immunophenotyping in Patients With Osteoporosis
An observational study of Immunophenotyping Blood Samples of Patients With Osteoporosis, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunophenotyping Blood Samples of Patients With Osteoporosis
- What is being tested?
- Immunological markers
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2021to 19 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with diagnosed osteoporosis will be analyzed in this study.
Who may be able to join
- Adult patients (≥ 18 years) diagnosed with osteoporosis.
- Written informed consent from the patient
Who cannot join
- Patients without diagnosed osteoporosis
- Patients without written informed consent
- Patients < 18 years old
- Patients with secondary osteoporosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Bonn
Bonn, Northrhine Westfalia, 53127
Andreas Strauß, PD Dr.
Andreas Strauß, PD Dr.
About this study
Official title: Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis
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.
Read the 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.
- Being tested
- Immunological markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunological markersDiagnostic test
Markers of blood samples of patients suffering from osteoporosis will be analyzed
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
DXA Values
Measurement of bone surface density using DXA scans
Measured: 30 minutes
Secondary outcomes (3)
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.
Measured: 5 Minutes
Menstruation
Patients are also asked whether the measurements take place at the time of their menstruation.
Measured: 2 Minutes
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.
Measured: 3 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start10 Oct 2021
- Primary completion19 Feb 2026 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunophenotyping Blood Samples of Patients With OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Andreas Strauß, University Hospital, Bonn
- Investigators
- Andreas Strauß, PD Dr., Principal investigator, physican
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132348
- Sponsor's protocol ID
- IPO15102021
- Acronym
- IPO
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Markers for the Improvement of Diagnosis and Therapy of Osteoporosis
- ClinicalTrials.gov ID
- NCT05132348
- Acronym / sponsor ID
- IPO / IPO15102021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 19 Feb 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed osteoporosis will be analyzed in this study.
Key inclusion criteria (2 listed)
- Adult patients (≥ 18 years) diagnosed with osteoporosis.
- Written informed consent from the patient
Key exclusion criteria (4 listed)
- Patients without diagnosed osteoporosis
- Patients without written informed consent
- Patients < 18 years old
- Patients with secondary osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunological markersMarkers of blood samples of patients suffering from osteoporosis will be analyzed | Diagnostic test | – |
Primary outcome
Immunological Marker
Time frame: 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
Time frame: 30 minutes
Measurement of bone surface density using DXA scans
3 secondary outcomes
Secondary Osteoporosis
Time frame: 5 Minutes
Menstruation
Time frame: 2 Minutes
Anthropometric Data
Time frame: 3 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Strauß, PD Dr. principal investigator
physican
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunophenotyping Blood Samples of Patients With Osteoporosis, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Strauß, PD Dr. (004922828714176, andreas.strauss@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological Marker (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.