NCT05823558

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

April 10, 2023

Last Update Submit

November 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lomber Muscle Measurement

    Psoas and multifidus muscle measurements will be made at L2-L3 level in Lumbar MR imaging.

    Day 1

Study Arms (3)

Ostoporotic Patients Group

T value of -2.5 and below in DEXA measurement

Diagnostic Test: Lomber Muscle Thickness Measurement

Osteopenic Patients Group

T value between -2.5 and -1 in DEXA measurement

Diagnostic Test: Lomber Muscle Thickness Measurement

Healthy Group

T value of -1 and above in DEXA measurement

Diagnostic Test: Lomber Muscle Thickness Measurement

Interventions

Muscle thickness measurements will be made on the imaging of those who have lumbar MR imaging.

Healthy GroupOsteopenic Patients GroupOstoporotic Patients Group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50-90 years old osteoporotic, osteopenic and healthy people

You may qualify if:

  • years old
  • \. Recent MRI of the lumbar region with DEXA evaluation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etfal Training and Research Hospital

Istanbul, Istanbul, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 10, 2023

First Posted

April 21, 2023

Study Start

August 15, 2023

Primary Completion

August 15, 2024

Study Completion

August 30, 2024

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations