SarcopeniaNCT06508957
Sarcopenia and Bone Mineral Density Relation in Hip Fracture Patients
An observational study of Sarcopenia and Hip Fractures, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 58 to 95 years
- Conditions the study is for
- Sarcopenia, Hip Fractures
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Nov 2023
- How long will I take part?
- 1 Week
- 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 58 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hip fracture patients attending the orthopedic clinics of a tertiary hospital in Kastamonu, Turkey.
Who may be able to join
- the detection of low muscle strength with a hand dynamometer
- scheduled for hip fracture surgery.
Who cannot join
- terminal disease
- acute or chronic neuromuscular disease
- traumatic or pathological hip fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Sarcopenia and Bone Mineral Density Relation in Hip Fracture Patients: A Cross-Sectional Study by Using STAR Value
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 <1.4 for males). Sociodemographic data of the patients and levels of total protein, albumin, and 25-OH-vitamin D3 (25[OH]D) 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).
Read the 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.
- Material and Method
2.1. 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.
2.2 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.
2.3. 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 (25[OH]D) levels were collected. The normal range for total protein is 6.6-8.3 g/dl, for albumin, it is 3.5-5.2 g/dl, and for 25[OH]D levels: deficient (<20 ng/dl), insufficient (20-30 ng/dl), or normal (>30 ng/dl).
2.4. Dual Energy X-ray Absorptiometry (DXA)
Non-fracture proximal femur neck BMD (g/cm2) 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, and/or 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 -2.5 SD and -1 SD, and as osteoporotic if it equals or falls below - 2.5 SD. As only a small number of subjects presented with osteoporosis, "severe" osteopenia (-2.5 SD<T score ≤-2.0 SD) was added to the classification in our population.
2.5. Muscle Ultrasound(US) 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.
2.6. 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 <1.4 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 study's 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 (kg/m2). According to prior research, the study used the established sonographic thigh adjustment ratio values of 1.0 for female patients and 1.4 for male subjects.
2.7. 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. Spearman's rho was used to investigate associations between nonparametric variables.
- Conditions
- Sarcopenia, Hip Fractures
- Keywords
- Sarcopenia, Hip Fractures, ultrasonic diagnosis
- Medical subject headings
- Sarcopenia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hip fracture patients | this is a observational study. There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (g/cm2)
Non-fracture proximal femur neck BMD (g/cm2) was obtained using the same DXA (Stratos DR (DMS), Mauguio, France)
Measured: baseline
Sonographic Thigh Adjustment Ratio (STAR) value
The study used the standard sonographic thigh adjustment ratio values of 1.0 for female patients and 1.4 for male patients. These values are found by dividing the thickness of the anterior thigh muscle (in mm) by the person's body mass (in kg/m2).
Measured: baseline
T-scores
A non-fracture proximal femur neck T score was obtained using the same DXA and is classified as normal if their T score exceeds -1 standard deviation (SD), as osteopenic if it falls between -2.5 SD and -1 SD, and as osteoporotic if it equals or falls below -2.5 SD.
Measured: baseline
Secondary outcomes (3)
25[OH]D levels
Measured: baseline
Albumin levels
Measured: baseline
Protein levels
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 May 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Gul Gulec, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508957
- Sponsor's protocol ID
- 2024-KAEK-26- 01
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
PubMed 31171417Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Mayhew AJ, Amog K, Phillips S, Parise G, McNicholas PD, de Souza RJ, Thabane L, Raina P. The prevalence of sarcopenia in community-dwelling older adults, an exploration of differences between studies and within definitions: a systematic review and meta-analyses. Age Ageing. 2019 Jan 1;48(1):48-56. doi: 10.1093/ageing/afy106.
PubMed 30052707Teng Z, Zhu Y, Teng Y, Long Q, Hao Q, Yu X, Yang L, Lv Y, Liu J, Zeng Y, Lu S. The analysis of osteosarcopenia as a risk factor for fractures, mortality, and falls. Osteoporos Int. 2021 Nov;32(11):2173-2183. doi: 10.1007/s00198-021-05963-x. Epub 2021 Apr 20.
PubMed 33877382Gupta M, Lehl SS, Lamba AS. Ultrasonography for Assessment of Sarcopenia: A Primer. J Midlife Health. 2022 Oct-Dec;13(4):269-277. doi: 10.4103/jmh.jmh_234_22. Epub 2023 Apr 28.
PubMed 37324795Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
PubMed 32941253Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
PubMed 34121127Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, Erten N, Karan MA, Cruz-Jentoft AJ. Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition. Clin Nutr. 2016 Dec;35(6):1557-1563. doi: 10.1016/j.clnu.2016.02.002. Epub 2016 Feb 11.
PubMed 26922142Miron Mombiela R, Vucetic J, Rossi F, Tagliafico AS. Ultrasound Biomarkers for Sarcopenia: What Can We Tell So Far? Semin Musculoskelet Radiol. 2020 Apr;24(2):181-193. doi: 10.1055/s-0039-3402745. Epub 2020 May 21.
PubMed 32438444
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sarcopenia and Bone Mineral Density Relation in Hip Fracture Patients: A Cross-Sectional Study by Using STAR Value
- ClinicalTrials.gov ID
- NCT06508957
- Acronym / sponsor ID
- 2024-KAEK-26- 01
- Conditions
- Sarcopenia, Hip Fractures
- Keywords
- Sarcopenia, Hip Fractures, ultrasonic diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Jul 2024 (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.
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 <1.4 for males). Sociodemographic data of the patients and levels of total protein, albumin, and 25-OH-vitamin D3 (25[OH]D) 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.
- Material and Method
2.1. 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.
2.2 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.
2.3. 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 (25[OH]D) levels were collected. The normal range for total protein is 6.6-8.3 g/dl, for albumin, it is 3.5-5.2 g/dl, and for 25[OH]D levels: deficient (<20 ng/dl), insufficient (20-30 ng/dl), or normal (>30 ng/dl).
2.4. Dual Energy X-ray Absorptiometry (DXA)
Non-fracture proximal femur neck BMD (g/cm2) 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, and/or 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 -2.5 SD and -1 SD, and as osteoporotic if it equals or falls below - 2.5 SD. As only a small number of subjects presented with osteoporosis, "severe" osteopenia (-2.5 SD<T score ≤-2.0 SD) was added to the classification in our population.
2.5. Muscle Ultrasound(US) 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.
2.6. 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 <1.4 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 study's 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 (kg/m2). According to prior research, the study used the established sonographic thigh adjustment ratio values of 1.0 for female patients and 1.4 for male subjects.
2.7. 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. Spearman's rho was used to investigate associations between nonparametric variables.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture patients | – | –this is a observational study. There is no intervention. |
Who may qualify
- Ages
- 58 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hip fracture patients attending the orthopedic clinics of a tertiary hospital in Kastamonu, Turkey.
Key inclusion criteria (2 listed)
- the detection of low muscle strength with a hand dynamometer
- scheduled for hip fracture surgery.
Key exclusion criteria (3 listed)
- terminal disease
- acute or chronic neuromuscular disease
- traumatic or pathological hip fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density (g/cm2)
Time frame: baseline
Non-fracture proximal femur neck BMD (g/cm2) was obtained using the same DXA (Stratos DR (DMS), Mauguio, France)
Sonographic Thigh Adjustment Ratio (STAR) value
Time frame: baseline
The study used the standard sonographic thigh adjustment ratio values of 1.0 for female patients and 1.4 for male patients. These values are found by dividing the thickness of the anterior thigh muscle (in mm) by the person's body mass (in kg/m2).
T-scores
Time frame: baseline
A non-fracture proximal femur neck T score was obtained using the same DXA and is classified as normal if their T score exceeds -1 standard deviation (SD), as osteopenic if it falls between -2.5 SD and -1 SD, and as osteoporotic if it equals or falls below -2.5 SD.
3 secondary outcomes
25[OH]D levels
Time frame: baseline
Albumin levels
Time frame: baseline
Protein levels
Time frame: baseline
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 18 Jul 2024.
- Background: PubMed 31171417Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 30052707Mayhew AJ, Amog K, Phillips S, Parise G, McNicholas PD, de Souza RJ, Thabane L, Raina P. The prevalence of sarcopenia in community-dwelling older adults, an exploration of differences between studies and within definitions: a systematic review and meta-analyses. Age Ageing. 2019 Jan 1;48(1):48-56. doi: 10.1093/ageing/afy106.
- Background: PubMed 33877382Teng Z, Zhu Y, Teng Y, Long Q, Hao Q, Yu X, Yang L, Lv Y, Liu J, Zeng Y, Lu S. The analysis of osteosarcopenia as a risk factor for fractures, mortality, and falls. Osteoporos Int. 2021 Nov;32(11):2173-2183. doi: 10.1007/s00198-021-05963-x. Epub 2021 Apr 20.
- Background: PubMed 37324795Gupta M, Lehl SS, Lamba AS. Ultrasonography for Assessment of Sarcopenia: A Primer. J Midlife Health. 2022 Oct-Dec;13(4):269-277. doi: 10.4103/jmh.jmh_234_22. Epub 2023 Apr 28.
- Background: PubMed 32941253Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
- Background: PubMed 34121127Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
- Background: PubMed 26922142Bahat G, Tufan A, Tufan F, Kilic C, Akpinar TS, Kose M, Erten N, Karan MA, Cruz-Jentoft AJ. Cut-off points to identify sarcopenia according to European Working Group on Sarcopenia in Older People (EWGSOP) definition. Clin Nutr. 2016 Dec;35(6):1557-1563. doi: 10.1016/j.clnu.2016.02.002. Epub 2016 Feb 11.
- Background: PubMed 32438444Miron Mombiela R, Vucetic J, Rossi F, Tagliafico AS. Ultrasound Biomarkers for Sarcopenia: What Can We Tell So Far? Semin Musculoskelet Radiol. 2020 Apr;24(2):181-193. doi: 10.1055/s-0039-3402745. Epub 2020 May 21.
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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 Sarcopenia and Hip Fractures, run by Kastamonu 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 2 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 18 Jul 2024. 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?
Bone Mineral Density (g/cm2) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508957, which also lists 9 linked publications.
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 18 Jul 2024.