Osteoporosis, PostmenopausalNCT04748029
Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis
An observational study of Osteoporosis, Postmenopausal and Osteoporotic Fractures, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteoporotic Fractures
- What is being tested?
- Systemic immune inflammation index
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Feb 2021
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Having applied to our clinic with the diagnosis or pre-diagnosis of postmenopausal osteoporosis or osteoporosis with pathological fractures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Systemic immune inflammation index
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic immune inflammation indexOther
The systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count. 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic immune inflammation index (SII)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748029
- Sponsor's protocol ID
- 2020-4-26
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT04748029
- Acronym / sponsor ID
- 2020-4-26
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 10 Feb 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Having applied to our clinic with the diagnosis or pre-diagnosis of postmenopausal osteoporosis or osteoporosis with pathological fractures
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Systemic immune inflammation indexThe systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count. 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoporosis, Postmenopausal and Osteoporotic Fractures, run by Ufuk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic immune inflammation index (SII) (time frame: 1 month). 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 10 Feb 2021.