Comparison of Lumbar Muscle Thickness Measurements in Osteoporotic and Osteopenic Patients

August 13, 2023 updated by: Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
In osteoporosis, sarcopenia is a common condition. Sarcopenic measurements can be made by evaluating muscle thickness in different regions. We aim to evaluate lumbar muscle losses in patients with osteoporosis in the lumbar region and to examine whether these muscle losses are correlated with the level of osteoporosis. The patients will be divided into 3 groups as healthy, osteopenic and osteoporotic according to DEXA measurements. Demographic values, comorbidities, osteoporosis drugs used, fracture histories, L1-4, L2-4, femoral neck and total BMD and t values of the patients, psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging. Lumbar MR muscle measurements will be made by 1 physician blind to the DEXA values of the patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

50-90 years old osteoporotic, osteopenic and healthy people

Description

Inclusion Criteria:

  • 50-90 years old
  • 2. Recent MRI of the lumbar region with DEXA evaluation

Exclusion Criteria:

  • Have had previous lumbar surgery
  • Any previous lumbar injection
  • Stage 3-4 Lumbar Listesis
  • Presence of Lumbar Discopathy accompanied by neurological deficit

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ostoporotic Patients Group
T value of -2.5 and below in DEXA measurement
Diagnostic test: Lomber Muscle Thickness Measurement
Muscle thickness measurements will be made on the imaging of those who have lumbar MR imaging.
Osteopenic Patients Group
T value between -2.5 and -1 in DEXA measurement
Diagnostic test: Lomber Muscle Thickness Measurement
Muscle thickness measurements will be made on the imaging of those who have lumbar MR imaging.
Healthy Group
T value of -1 and above in DEXA measurement
Diagnostic test: Lomber Muscle Thickness Measurement
Muscle thickness measurements will be made on the imaging of those who have lumbar MR imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lomber Muscle Measurement
Time Frame: Day 1
Psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

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 (Estimated)

August 15, 2023

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10042023

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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