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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Andreas Strauß, PD Dr. contact

004922828714176

andreas.strauss@ukbonn.de

Germany1 site, 1 recruiting
  • University Hospital of Bonn

    Bonn, Northrhine Westfalia, 53127

    Andreas Strauß, PD Dr.

    Andreas Strauß, PD Dr.

    Recruiting

Other trials in Germany

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.

  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.

    Measured: 2 hours

  2. DXA Values

    Measurement of bone surface density using DXA scans

    Measured: 30 minutes

Secondary outcomes (3)
  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.

    Measured: 5 Minutes

  2. Menstruation

    Patients are also asked whether the measurements take place at the time of their menstruation.

    Measured: 2 Minutes

  3. 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.

  1. First posted24 Nov 2021
  2. Study start10 Oct 2021
  3. Primary completion19 Feb 2026 (estimated)
  4. Study completion19 Oct 2026 (estimated)

Resources

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)
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

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.

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