Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508957
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Sarcopenia and Bone Mineral Density Relation in Hip Fracture Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Sarcopenia and Bone Mineral Density Relation in Hip Fracture Patients A Cross-Sectional Study by Using STAR Value
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to investigate the relationship between sarcopenia and bone mineral density BMD in patients with hip fractures using sonographic thigh adjustment ratio STAR and dual-energy X-ray absorptiometry DXA as well as the relationship of sociodemographic factors laboratory results and comorbidities to these measurements
Cross-sectional research was undertaken on patients with hip fractures in Kastamonu Turkey Sarcopenia was identified based on the ISarcoPRM algorithm which utilizes poor grip strength 22 kg for females and 32 kg for males along with low STAR values 1 for females and 14 for males Sociodemographic data of the patients and levels of total protein albumin and 25-OH-vitamin D3 25OHD were obtained from all the patients The BMD bone mineral density and T-scores of the proximal femur were measured using DXA dual-energy X-ray absorptiometry
Cross-sectional research was undertaken on patients with hip fractures in Kastamonu Turkey Sarcopenia was identified based on the ISarcoPRM algorithm which utilizes poor grip strength 22 kg for females and 32 kg for males along with low STAR values 1 for females and 14 for males Sociodemographic data of the patients and levels of total protein albumin and 25-OH-vitamin D3 25OHD were obtained from all the patients The BMD bone mineral density and T-scores of the proximal femur were measured using DXA dual-energy X-ray absorptiometry
Detailed Description:
Introduction
Sarcopenia is a progressive and common skeletal muscle disorder that causes progressive loss of age-related muscle strength and mass associated with an increased likelihood of outcomes such as falls fractures physical disability and death Estimates place the overall prevalence of sarcopenia in older adults at approximately 10-40 Osteoporosis and sarcopenia prevalent conditions of advanced age have comparable etiologies and risk factors The co-occurrence of these illnesses amplifies the incidence of falls fractures and mortality While EWGSOP2 and AWGS guidelines recommend using validated technologies like bioimpedance analysis dual X-ray absorptiometry DXA computed tomography and magnetic resonance imaging for evaluating sarcopenia these may not be feasible in certain clinical situations The International Society of Physical and Rehabilitation Medicine ISPRM has suggested a different algorithm to diagnose sarcopenia by measuring anterior thigh muscle thickness using ultrasound US This method is easy to obtain does not involve radiation and is less expensive
The study uses the sonographic thigh adjustment ratio STAR to look into the link between sarcopenia and bone mineral density BMD in people who have had a hip fracture Additionally the study explores the association between sociodemographic factors laboratory results comorbidities and these measurements
2 Material and Method
21 Study Design and Population
An observational cross-sectional study was conducted on hip fracture patients attending the orthopedic clinics of a tertiary hospital in Kastamonu Turkey The study was approved by the local Institutional Review Board 2024-KAEK-26- 01 February 7th 2024 Written informed consent was obtained from all participants Subjects were consecutively recruited during the first 24 hours of hospital stay from May to November 2023 Sarcopenia was diagnosed using the ISarcoPRM algorithm which considers low grip strength and low STAR values Inclusion criteria included the detection of low muscle strength with a hand dynamometer and patients scheduled for hip fracture surgery Exclusion criteria included terminal disease acute or chronic neuromuscular disease and traumatic or pathological hip fracture
22 Handgrip strength
Handgrip strength was measured using a Jamar dynamometer Baseline Hydraulic Hand dynamometer Irvington NY with participants performing two trials with both hands The highest value obtained was used for analysis Cut-off values for Turkish people were 22 kg for women and 32 kg for men
23 Laboratory Data
The Kastamonu Research and Training Hospital Laboratory Service a medical laboratory service with Turkey Accreditation System accreditation performed laboratory analyses on-site Total protein albumin and 25-OH-vitamin D3 25OHD levels were collected The normal range for total protein is 66-83 gdl for albumin it is 35-52 gdl and for 25OHD levels deficient 20 ngdl insufficient 20-30 ngdl or normal 30 ngdl
24 Dual Energy X-ray Absorptiometry DXA
Non-fracture proximal femur neck BMD gcm2 and T-scores were obtained using the same DXA Stratos DR DMS Mauguio France The World Health Organization WHO categorizes patients based on their lumbar spine femoral neck andor total hip bone mineral density BMD Patients are classified as normal if their T score exceeds -1 standard deviation SD as osteopenic if it falls between -25 SD and -1 SD and as osteoporotic if it equals or falls below - 25 SD As only a small number of subjects presented with osteoporosis severe osteopenia -25 SDT score -20 SD was added to the classification in our population
25 Muscle UltrasoundUS Measurements
Evaluation with the US Mylab 25Gold Esaote Genova Italy was planned to be performed by the same clinicians using a 5-15 MHz linear probe in B mode with the technique reported in previous studies The thickness of the anterior thigh muscles was assessed in the non-fractured limb between the anterior superior iliac spine and the proximal end of the patella with the patient lying in the supine position and the US probe placed perpendicularly with slight pressure Once the muscle tissue was identified the distance was measured between the femoral cortex and the most superficial muscle fascia 7 Measurements were obtained on two separate occasions by two different clinicians The average value of a set of four consecutive measurements was calculated to assess the STAR value
26 Sarcopenia Diagnosis
Sarcopenia was diagnosed according to the ISarcoPRM algorithm using low grip strength 22 kg for females and 32 kg for males with low STAR values 1 for females and 14 for males The chair stand test which is also recommended as a power and performance test to assess anterior thigh muscle function is unsuitable for this studys population with hip fractures The STAR value was utilized to confirm the diagnosis It is calculated by dividing the anterior thigh muscle thickness mm by the body mass value kgm2 According to prior research the study used the established sonographic thigh adjustment ratio values of 10 for female patients and 14 for male subjects
27 Statistical Analyses
Statistical analyses were performed with the SPSS v22 SPSS Inc Chicago IL USA package Quantitative data were summarized by mean standard deviation and median minimum-maximum while qualitative data were depicted as frequency and percentage The Shapiro-Wilk test was performed to assess the normal distribution of the data while the Levene test tested the homogeneity of variances Two-sided independent t-tests were used to compare the mean for observations between sarcopenic and normal patients Linear regressions and the Pearson coefficient were used to investigate associations and examine the relationship between parametric variables Spearmans rho was used to investigate associations between nonparametric variables
Sarcopenia is a progressive and common skeletal muscle disorder that causes progressive loss of age-related muscle strength and mass associated with an increased likelihood of outcomes such as falls fractures physical disability and death Estimates place the overall prevalence of sarcopenia in older adults at approximately 10-40 Osteoporosis and sarcopenia prevalent conditions of advanced age have comparable etiologies and risk factors The co-occurrence of these illnesses amplifies the incidence of falls fractures and mortality While EWGSOP2 and AWGS guidelines recommend using validated technologies like bioimpedance analysis dual X-ray absorptiometry DXA computed tomography and magnetic resonance imaging for evaluating sarcopenia these may not be feasible in certain clinical situations The International Society of Physical and Rehabilitation Medicine ISPRM has suggested a different algorithm to diagnose sarcopenia by measuring anterior thigh muscle thickness using ultrasound US This method is easy to obtain does not involve radiation and is less expensive
The study uses the sonographic thigh adjustment ratio STAR to look into the link between sarcopenia and bone mineral density BMD in people who have had a hip fracture Additionally the study explores the association between sociodemographic factors laboratory results comorbidities and these measurements
2 Material and Method
21 Study Design and Population
An observational cross-sectional study was conducted on hip fracture patients attending the orthopedic clinics of a tertiary hospital in Kastamonu Turkey The study was approved by the local Institutional Review Board 2024-KAEK-26- 01 February 7th 2024 Written informed consent was obtained from all participants Subjects were consecutively recruited during the first 24 hours of hospital stay from May to November 2023 Sarcopenia was diagnosed using the ISarcoPRM algorithm which considers low grip strength and low STAR values Inclusion criteria included the detection of low muscle strength with a hand dynamometer and patients scheduled for hip fracture surgery Exclusion criteria included terminal disease acute or chronic neuromuscular disease and traumatic or pathological hip fracture
22 Handgrip strength
Handgrip strength was measured using a Jamar dynamometer Baseline Hydraulic Hand dynamometer Irvington NY with participants performing two trials with both hands The highest value obtained was used for analysis Cut-off values for Turkish people were 22 kg for women and 32 kg for men
23 Laboratory Data
The Kastamonu Research and Training Hospital Laboratory Service a medical laboratory service with Turkey Accreditation System accreditation performed laboratory analyses on-site Total protein albumin and 25-OH-vitamin D3 25OHD levels were collected The normal range for total protein is 66-83 gdl for albumin it is 35-52 gdl and for 25OHD levels deficient 20 ngdl insufficient 20-30 ngdl or normal 30 ngdl
24 Dual Energy X-ray Absorptiometry DXA
Non-fracture proximal femur neck BMD gcm2 and T-scores were obtained using the same DXA Stratos DR DMS Mauguio France The World Health Organization WHO categorizes patients based on their lumbar spine femoral neck andor total hip bone mineral density BMD Patients are classified as normal if their T score exceeds -1 standard deviation SD as osteopenic if it falls between -25 SD and -1 SD and as osteoporotic if it equals or falls below - 25 SD As only a small number of subjects presented with osteoporosis severe osteopenia -25 SDT score -20 SD was added to the classification in our population
25 Muscle UltrasoundUS Measurements
Evaluation with the US Mylab 25Gold Esaote Genova Italy was planned to be performed by the same clinicians using a 5-15 MHz linear probe in B mode with the technique reported in previous studies The thickness of the anterior thigh muscles was assessed in the non-fractured limb between the anterior superior iliac spine and the proximal end of the patella with the patient lying in the supine position and the US probe placed perpendicularly with slight pressure Once the muscle tissue was identified the distance was measured between the femoral cortex and the most superficial muscle fascia 7 Measurements were obtained on two separate occasions by two different clinicians The average value of a set of four consecutive measurements was calculated to assess the STAR value
26 Sarcopenia Diagnosis
Sarcopenia was diagnosed according to the ISarcoPRM algorithm using low grip strength 22 kg for females and 32 kg for males with low STAR values 1 for females and 14 for males The chair stand test which is also recommended as a power and performance test to assess anterior thigh muscle function is unsuitable for this studys population with hip fractures The STAR value was utilized to confirm the diagnosis It is calculated by dividing the anterior thigh muscle thickness mm by the body mass value kgm2 According to prior research the study used the established sonographic thigh adjustment ratio values of 10 for female patients and 14 for male subjects
27 Statistical Analyses
Statistical analyses were performed with the SPSS v22 SPSS Inc Chicago IL USA package Quantitative data were summarized by mean standard deviation and median minimum-maximum while qualitative data were depicted as frequency and percentage The Shapiro-Wilk test was performed to assess the normal distribution of the data while the Levene test tested the homogeneity of variances Two-sided independent t-tests were used to compare the mean for observations between sarcopenic and normal patients Linear regressions and the Pearson coefficient were used to investigate associations and examine the relationship between parametric variables Spearmans rho was used to investigate associations between nonparametric variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None