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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Gamze Gül Güleç

    Kastamonu, 37150

Other trials in Turkey (Türkiye)

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.

  1. 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.

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 groups in NCT06508957
Study groupRoleWhat they receive
hip fracture patientsthis 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.

  1. 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

  2. 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

  3. 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)
  1. 25[OH]D levels

    Measured: baseline

  2. Albumin levels

    Measured: baseline

  3. 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.

  1. First posted18 Jul 2024
  2. Study start1 May 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

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
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 31171417
  • Cruz-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 20392703
  • Mayhew 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 30052707
  • Teng 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 33877382
  • Gupta 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 37324795
  • Kara 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 32941253
  • Kara 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 34121127
  • Bahat 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 26922142
  • Miron 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

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.

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