- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748029
Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis
February 5, 2021 updated by: Elzem Bolkan Günaydın, Ufuk University
This study is a retrospective case-control study.
In the study, the data of 304 patients who were evaluated in our clinic between January 2017 and January 2020 with a pre-diagnosis or diagnosis of postmenopausal osteoporosis were retrospectively reviewed.
Lumbar 1-4 and femoral neck bone mineral densitometry values T scores, ages, sedimentation, C-reactive protein, neutrophil, leukocyte and platelet levels, and mean platelet volume values of the patients were recorded.
The neutrophil-lymphocyte ratio was calculated by dividing the neutrophil count by the lymphocyte count, and the platelet-lymphocyte ratio was calculated by dividing the platelet count by the lymphocyte count.
The systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count.
The aim of this study is to evaluate the prognostic value of the systemic immune inflammation index in postmenopausal osteoporosis and to examine the SII, N / L, PLT / L, MPV, sedimentation (ESR), C reactive protein (CRP), femur and lumbar BMD values and their relationships with each other.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
139
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06520
- Ufuk University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
In the study, the data of 139 patients who were evaluated in our clinic between January 2017 and January 2020 with a pre-diagnosis or diagnosis of postmenopausal osteoporosis were retrospectively reviewed.
Description
Inclusion Criteria:
- Having applied to our clinic with the diagnosis or pre-diagnosis of postmenopausal osteoporosis or osteoporosis with pathological fractures
Exclusion Criteria:
- Having a diagnosis of osteoporosis due to conditions other than postmenopausal osteoporosis
- Those with acute or chronic infection, malignancy and systemic diseases that may change the hematological inflammation parameters to be checked
- Persons who are missing one or more of the parameters planned to be considered among the obtained data
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic immune inflammation index (SII)
Time Frame: 1 month
|
Systemic immune inflammation index (SII) is a new index related to systemic inflammation calculated by the numbers of lymphocytes, neutrophils and platelets in peripheral blood defined in 2014.
The systemic immune inflammation index (SII) is calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-4-26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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