SarcopeniaSARCATARNCT06488872
Comparison of Computed Tomography Data With Routine Measurements Concerning Bone and Muscle Health of Aged Individuals
An observational study of Sarcopenia and Muscle Loss, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
Trial summary
This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Muscle Loss, Osteoporosis
- What is being tested?
- comparison of CT scan with routinely assessed methods of muscle mass and strength
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2024to 1 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We would like to retrospectively examine a total of 300 data sets of geriatric patients from 01.01.2017 to 31.12.2022, who were treated as inpatients at the UAFP. Individuals will be identified using various databases containing information on patients who have undergone CT scans imaging the thoracic and/or abdominal organs and DEXA scans. Participants must have had a CT scan performed by the in-house radiology department one month before or after the inpatient stay. In order to be included in the osteoporosis arm, a thorax and/or abdomen CT scan and a DEXA scan from an in-house DEXA measurement must be available. Both examinations must not be more than 18 months apart.
Who may be able to join
- CT examination (thorax, abdomen, pelvis, spine with muscle parts to be visualized) by the responsible in-house radiology department one month before or after the inpatient stay at the UAFP (sarcopenia arm).
- CT thorax and CT abdomen images of patients from the responsible in-house radiology department and an in-house DEXA measurement. Both examinations may be performed no more than 18 months apart (osteoporosis arm).
- Diagnostic image quality of CT scans.
Who cannot join
- Presence of a documented refusal.
- Non-diagnostic image quality
- Absence of the following functional measurements: Hand strength on both hands, timed-up \& go test, gait speed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Universitäre Altersmedizin Felix Platter
Basel, Canton of Basel-City, 4055
About this study
Official title: Comparison of Artificial Intelligence-based Analysis of Computed Tomography Data With Routinely Performed Measurements Concerning Bone and Muscle Health of Aged Individuals to Validate Surrogate Parameters for the Aging Population.
This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals impairments. To address these challenges, the study employs innovative imaging techniques based on artificial intelligence (AI) to accurately assess age-related muscle atrophy. A central approach is to analyze existing computed tomography (CT) images of older adults, using retrospective data to evaluate muscle quality. This method aims to efficiently assess muscle quality without additional resources. AI algorithms analyze fine details of muscle tissue, such as muscle adiposity and density. The algorithm can detect fat content within muscles, which negatively impacts muscle health and functionality, and identify irregularities or abnormalities in muscle fibers. This non-invasive approach is crucial for early detection of muscle atrophy and monitoring treatment success. Integrating AI technologies advances beyond conventional imaging techniques, allowing precise analysis of muscle quality. This method not only offers efficient diagnosis and monitoring of sarcopenia but also opens new avenues for personalized therapeutic approaches and improved patient care. Almost every elderly person has at least one existing CT scan, a common and excellent method of medical imaging for significant health issues. These images can be retrospectively analyzed for muscle health. In addition to imaging techniques, the study includes functional tests such as hand strength and walking speed measurements to assess muscle health and condition. These tests establish objective quality characteristics of muscles and assess the effectiveness of prevention and treatment measures. This research aims to provide early diagnosis and effective treatment strategies for sarcopenia and osteoporosis, ultimately improving the quality of life for the elderly. By leveraging AI and existing medical imaging data, the study promotes efficient, sustainable, and precise healthcare solutions for age-related muscle and bone deterioration.
Read the detailed description
Age-related muscle wasting and bone loss are significant public health challenges impacting elderly mobility and independence. Sarcopenia, a decline in muscle strength and mass, heightens fall risk, particularly in individuals with dementia or cognitive impairments. This leads to complications, reduced independence, and diminished quality of life. Osteoporosis increases the risk of fractures from falls or spontaneously, necessitating early diagnosis and prevention.
Despite effective treatments for sarcopenia, such as a protein-rich diet and strength training, the condition remains underrecognized due to diagnostic challenges. Common methods like hand strength measurement are problematic for those with rheumatic conditions or Parkinson's, often yielding inaccurate results. Other methods, like measuring leg strength and walking speed, require coordination and balance, which can be difficult for those with dementia or visual impairments. There is a need for tailored diagnostic solutions for diverse aging populations.
Bone mineral density (BMD) is crucial for assessing health in older adults, as low BMD indicates osteoporosis and a higher fracture risk. Traditionally measured by dual X-ray absorptiometry (DEXA), BMD assessment can be difficult for patients with mobility issues, pressure ulcers, or dementia due to the requirement to remain still for extended periods.
New AI-based algorithms can now automatically evaluate body tissues and patterns from routine CT scans, offering reproducible results beyond human capability. AI can quantify muscle mass at specific body cross-sections, such as lumbar vertebral point 3 (L3), which correlates with total body muscle mass and predicts muscle health. CT measurements of thigh and psoas muscles can also indicate whole body skeletal muscle mass. European guidelines highlight the need for muscle quantification in early sarcopenia diagnosis.
Correlating AI-measured muscle mass with functional muscle strength assessments can help identify surrogate parameters for early sarcopenia detection. Additionally, measuring muscle fat content, which correlates with strength loss, is essential for assessing muscle health. Innovative approaches are required, as sarcopenia diagnosis is still evolving and geriatric diseases often need proportionate diagnostic and treatment strategies due to multiple comorbidities.
For osteoporosis diagnostics, AI can determine Hounsfield Unit (HU) values from CT images to represent bone density, which can be correlated with DEXA results. These surrogate diagnostics should follow current guidelines, with results obtained within an appropriate interval of up to 18 months.
Based on the primary endpoints, the prevalence of "muscle-healthy" and "probably sarcopenic" individuals will be recorded. Additionally, the prevalence of individuals without osteoporosis, with osteopenia, and with confirmed osteoporosis will be calculated and included in the analysis.
The secondary endpoints compare functional muscle strength measurements with retrospective quantitative CT results. This exploratory analysis will test whether the AI algorithm can correlate functionality with muscle volume. Additionally, AI-measured muscle fatness (myosteatosis) could serve as a new, quantifiable quality criterion for muscle health. This is important because many elderly individuals cannot meet functional strength test requirements due to conditions like visual impairment, dementia, chronic pain, joint diseases, and frailty.
For osteoporosis diagnostics, the investigators aim to correlate bone density from DEXA measurements with CT-derived bone density of thoracic and abdominal vertebral bodies. This exploratory surrogate measurement method could provide insights into bone mineral density and health from existing CT images. CT-based diagnosis could be an alternative for those unable to remain still for DEXA scans.
Design:
This retrospective study will be conducted at a single center. Participants will be identified using databases of patients who have undergone CT and DEXA scans. To be included in the sarcopenia arm, participants must have had a CT scan from the radiology department at the University Hospital Basel within one month of an inpatient stay. For the osteoporosis arm, a thorax and/or abdomen CT scan and a DEXA scan must be available, conducted within 18 months of each other.
Anonymized DICOM datasets from the CT scans will be analyzed by an AI algorithm. Data analysis will involve standard statistical comparison using Student's t-test. The algorithm's values will be tested against reference standards, and its diagnostic accuracy will be evaluated for various diseases. The algorithm has been tested on 104 anatomical structures, organs, and organ groups (Req-2022-00495).
Origin of the data:
At the largest geriatric medical center in Switzerland, the investigators would like to include geriatric patients aged 65 and over who were undergoing inpatient treatment in the period from 01.07.2017 to 31.12.2022 inclusive.
By testing alternative diagnostic procedures (exploratory approach), the investigators want to reach more people, especially those who are unable to follow current diagnostic procedures due to dementia, visual impairment or post-operative condition. This is crucial as these patients in particular have a significantly increased risk of falling. The research approach aims to address real-world challenges in order to consider prevention programs and personalized therapies for as many people as possible in the future.
By using existing data and dispensing with further investigations, the economic aspect in the context of rising healthcare costs is also taken into account.
Scientific methodology and targets:
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoints:
- Sarcopenia: By evaluating muscle volume and fat percentage in muscle (in mm3) and density (in HU) on CT.
- Osteoporosis: By evaluating bone density/attenuation in HU on CT. For the evaluation of muscle volumes and densities, a feasibility study has already been carried out on a representative sample of over 4000 patients, which suggests a normal distribution of muscle density and volume (21). Statistical deviations from this reference group are determined using a t-test or Wilcoxon test in the case of a lack of normal distribution. The test for normal distribution is performed using the Kolmogorov-Smirnov test. The significance level is set at α = 0.05.
The evaluation of osteoporosis is performed analogously. The relationship between attenuation in HU and BMD has already been documented in the literature (22) (18).
Inclusion of as many patients as possible is essential for representative results
For which health-related personal data should consent be granted? A general consent form "Declaration of consent for the further use of health-related data and samples" was introduced at the beginning of 2020. Unfortunately, in practice it proved to be unreasonable to implement.
The investigators consider the sample size to be n=300. No consent has been obtained for any of the participants, meaning that an application for exemption is being made for all persons.
Quantitative, clinical data:
Hand strength measurement on both hands (geriatric routine assessment to assess the muscle strength of the upper extremity)
- Gait speed (geriatric routine assessment to assess mobility and muscle strength of the lower extremity; important for predicting falls)
- Timed up \& go (geriatric routine assessment to assess muscle strength of the lower extremity, coordination and sense of balance; important for predicting falls)
- Vitamin D level in serum (underestimated vitamin in old age, which is produced by the body itself through natural sunlight exposure of the skin and good kidney function in the investigators latitudes through many intermediate steps and contributes significantly to bone and muscle health; in the investigators latitudes (angle of incidence of the sun's rays), sufficient vitamin D production is only possible in the months of April to October with sufficient time spent outdoors. With age, however, the ability to synthesize vitamin D production also decreases considerably in the spring to summer months.
Quantitative data from imaging:
- Previous DEXA measurements of bone density (T-score, Z-score)
- Muscle mass and fat content in the muscle from previous CT scans (thorax, abdomen, pelvis, spine with muscle parts shown)
- Conditions
- Sarcopenia, Muscle Loss, Osteoporosis
- Being tested
- comparison of CT scan with routinely assessed methods of muscle mass and strength
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of CT scan with routinely assessed methods of muscle mass and strengthProcedure or surgery
comparison of CT scan with routinely assessed methods of muscle mass and strength
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Volume in mm3 on CT
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating muscle volume (in mm3) on CT.
Measured: through study completion, an average o 1 year
fat percentage in muscle density (in HU) on CT.
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating fat percentage in muscle density (in HU) on CT.
Measured: through study completion, an average o 1 year
bone density/attenuation in HU on CT.
Analysis of bone density/attenuation in HU on CT to evaluate the primary endpoint Osteoporosis:
Measured: through study completion, an average o 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 May 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Fischer, University Department of Geriatric Medicine FELIX PLATTER
- Investigators
- Andreas M. Fischer, PD Dr., Principal investigator, Universitäre Altersmedizin Felix Platter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488872
- Sponsor's protocol ID
- 2024-0705
- Acronym
- SARCATAR
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Artificial Intelligence-based Analysis of Computed Tomography Data With Routinely Performed Measurements Concerning Bone and Muscle Health of Aged Individuals to Validate Surrogate Parameters for the Aging Population.
- ClinicalTrials.gov ID
- NCT06488872
- Acronym / sponsor ID
- SARCATAR / 2024-0705
- Conditions
- Sarcopenia, Muscle Loss, Osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 5 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.
This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals impairments. To address these challenges, the study employs innovative imaging techniques based on artificial intelligence (AI) to accurately assess age-related muscle atrophy. A central approach is to analyze existing computed tomography (CT) images of older adults, using retrospective data to evaluate muscle quality. This method aims to efficiently assess muscle quality without additional resources. AI algorithms analyze fine details of muscle tissue, such as muscle adiposity and density. The algorithm can detect fat content within muscles, which negatively impacts muscle health and functionality, and identify irregularities or abnormalities in muscle fibers. This non-invasive approach is crucial for early detection of muscle atrophy and monitoring treatment success. Integrating AI technologies advances beyond conventional imaging techniques, allowing precise analysis of muscle quality. This method not only offers efficient diagnosis and monitoring of sarcopenia but also opens new avenues for personalized therapeutic approaches and improved patient care. Almost every elderly person has at least one existing CT scan, a common and excellent method of medical imaging for significant health issues. These images can be retrospectively analyzed for muscle health. In addition to imaging techniques, the study includes functional tests such as hand strength and walking speed measurements to assess muscle health and condition. These tests establish objective quality characteristics of muscles and assess the effectiveness of prevention and treatment measures. This research aims to provide early diagnosis and effective treatment strategies for sarcopenia and osteoporosis, ultimately improving the quality of life for the elderly. By leveraging AI and existing medical imaging data, the study promotes efficient, sustainable, and precise healthcare solutions for age-related muscle and bone deterioration.
Detailed description
Age-related muscle wasting and bone loss are significant public health challenges impacting elderly mobility and independence. Sarcopenia, a decline in muscle strength and mass, heightens fall risk, particularly in individuals with dementia or cognitive impairments. This leads to complications, reduced independence, and diminished quality of life. Osteoporosis increases the risk of fractures from falls or spontaneously, necessitating early diagnosis and prevention.
Despite effective treatments for sarcopenia, such as a protein-rich diet and strength training, the condition remains underrecognized due to diagnostic challenges. Common methods like hand strength measurement are problematic for those with rheumatic conditions or Parkinson's, often yielding inaccurate results. Other methods, like measuring leg strength and walking speed, require coordination and balance, which can be difficult for those with dementia or visual impairments. There is a need for tailored diagnostic solutions for diverse aging populations.
Bone mineral density (BMD) is crucial for assessing health in older adults, as low BMD indicates osteoporosis and a higher fracture risk. Traditionally measured by dual X-ray absorptiometry (DEXA), BMD assessment can be difficult for patients with mobility issues, pressure ulcers, or dementia due to the requirement to remain still for extended periods.
New AI-based algorithms can now automatically evaluate body tissues and patterns from routine CT scans, offering reproducible results beyond human capability. AI can quantify muscle mass at specific body cross-sections, such as lumbar vertebral point 3 (L3), which correlates with total body muscle mass and predicts muscle health. CT measurements of thigh and psoas muscles can also indicate whole body skeletal muscle mass. European guidelines highlight the need for muscle quantification in early sarcopenia diagnosis.
Correlating AI-measured muscle mass with functional muscle strength assessments can help identify surrogate parameters for early sarcopenia detection. Additionally, measuring muscle fat content, which correlates with strength loss, is essential for assessing muscle health. Innovative approaches are required, as sarcopenia diagnosis is still evolving and geriatric diseases often need proportionate diagnostic and treatment strategies due to multiple comorbidities.
For osteoporosis diagnostics, AI can determine Hounsfield Unit (HU) values from CT images to represent bone density, which can be correlated with DEXA results. These surrogate diagnostics should follow current guidelines, with results obtained within an appropriate interval of up to 18 months.
Based on the primary endpoints, the prevalence of "muscle-healthy" and "probably sarcopenic" individuals will be recorded. Additionally, the prevalence of individuals without osteoporosis, with osteopenia, and with confirmed osteoporosis will be calculated and included in the analysis.
The secondary endpoints compare functional muscle strength measurements with retrospective quantitative CT results. This exploratory analysis will test whether the AI algorithm can correlate functionality with muscle volume. Additionally, AI-measured muscle fatness (myosteatosis) could serve as a new, quantifiable quality criterion for muscle health. This is important because many elderly individuals cannot meet functional strength test requirements due to conditions like visual impairment, dementia, chronic pain, joint diseases, and frailty.
For osteoporosis diagnostics, the investigators aim to correlate bone density from DEXA measurements with CT-derived bone density of thoracic and abdominal vertebral bodies. This exploratory surrogate measurement method could provide insights into bone mineral density and health from existing CT images. CT-based diagnosis could be an alternative for those unable to remain still for DEXA scans.
Design:
This retrospective study will be conducted at a single center. Participants will be identified using databases of patients who have undergone CT and DEXA scans. To be included in the sarcopenia arm, participants must have had a CT scan from the radiology department at the University Hospital Basel within one month of an inpatient stay. For the osteoporosis arm, a thorax and/or abdomen CT scan and a DEXA scan must be available, conducted within 18 months of each other.
Anonymized DICOM datasets from the CT scans will be analyzed by an AI algorithm. Data analysis will involve standard statistical comparison using Student's t-test. The algorithm's values will be tested against reference standards, and its diagnostic accuracy will be evaluated for various diseases. The algorithm has been tested on 104 anatomical structures, organs, and organ groups (Req-2022-00495).
Origin of the data:
At the largest geriatric medical center in Switzerland, the investigators would like to include geriatric patients aged 65 and over who were undergoing inpatient treatment in the period from 01.07.2017 to 31.12.2022 inclusive.
By testing alternative diagnostic procedures (exploratory approach), the investigators want to reach more people, especially those who are unable to follow current diagnostic procedures due to dementia, visual impairment or post-operative condition. This is crucial as these patients in particular have a significantly increased risk of falling. The research approach aims to address real-world challenges in order to consider prevention programs and personalized therapies for as many people as possible in the future.
By using existing data and dispensing with further investigations, the economic aspect in the context of rising healthcare costs is also taken into account.
Scientific methodology and targets:
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoints:
- Sarcopenia: By evaluating muscle volume and fat percentage in muscle (in mm3) and density (in HU) on CT.
- Osteoporosis: By evaluating bone density/attenuation in HU on CT. For the evaluation of muscle volumes and densities, a feasibility study has already been carried out on a representative sample of over 4000 patients, which suggests a normal distribution of muscle density and volume (21). Statistical deviations from this reference group are determined using a t-test or Wilcoxon test in the case of a lack of normal distribution. The test for normal distribution is performed using the Kolmogorov-Smirnov test. The significance level is set at α = 0.05.
The evaluation of osteoporosis is performed analogously. The relationship between attenuation in HU and BMD has already been documented in the literature (22) (18).
Inclusion of as many patients as possible is essential for representative results
For which health-related personal data should consent be granted? A general consent form "Declaration of consent for the further use of health-related data and samples" was introduced at the beginning of 2020. Unfortunately, in practice it proved to be unreasonable to implement.
The investigators consider the sample size to be n=300. No consent has been obtained for any of the participants, meaning that an application for exemption is being made for all persons.
Quantitative, clinical data:
Hand strength measurement on both hands (geriatric routine assessment to assess the muscle strength of the upper extremity)
- Gait speed (geriatric routine assessment to assess mobility and muscle strength of the lower extremity; important for predicting falls)
- Timed up \& go (geriatric routine assessment to assess muscle strength of the lower extremity, coordination and sense of balance; important for predicting falls)
- Vitamin D level in serum (underestimated vitamin in old age, which is produced by the body itself through natural sunlight exposure of the skin and good kidney function in the investigators latitudes through many intermediate steps and contributes significantly to bone and muscle health; in the investigators latitudes (angle of incidence of the sun's rays), sufficient vitamin D production is only possible in the months of April to October with sufficient time spent outdoors. With age, however, the ability to synthesize vitamin D production also decreases considerably in the spring to summer months.
Quantitative data from imaging:
- Previous DEXA measurements of bone density (T-score, Z-score)
- Muscle mass and fat content in the muscle from previous CT scans (thorax, abdomen, pelvis, spine with muscle parts shown)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We would like to retrospectively examine a total of 300 data sets of geriatric patients from 01.01.2017 to 31.12.2022, who were treated as inpatients at the UAFP. Individuals will be identified using various databases containing information on patients who have undergone CT scans imaging the thoracic and/or abdominal organs and DEXA scans. Participants must have had a CT scan performed by the in-house radiology department one month before or after the inpatient stay. In order to be included in the osteoporosis arm, a thorax and/or abdomen CT scan and a DEXA scan from an in-house DEXA measurement must be available. Both examinations must not be more than 18 months apart.
Key inclusion criteria (3 listed)
- CT examination (thorax, abdomen, pelvis, spine with muscle parts to be visualized) by the responsible in-house radiology department one month before or after the inpatient stay at the UAFP (sarcopenia arm).
- CT thorax and CT abdomen images of patients from the responsible in-house radiology department and an in-house DEXA measurement. Both examinations may be performed no more than 18 months apart (osteoporosis arm).
- Diagnostic image quality of CT scans.
Key exclusion criteria (3 listed)
- Presence of a documented refusal.
- Non-diagnostic image quality
- Absence of the following functional measurements: Hand strength on both hands, timed-up \& go test, gait speed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of CT scan with routinely assessed methods of muscle mass and strengthcomparison of CT scan with routinely assessed methods of muscle mass and strength | Procedure or surgery | – |
Primary outcome
Muscle Volume in mm3 on CT
Time frame: through study completion, an average o 1 year
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating muscle volume (in mm3) on CT.
fat percentage in muscle density (in HU) on CT.
Time frame: through study completion, an average o 1 year
Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating fat percentage in muscle density (in HU) on CT.
bone density/attenuation in HU on CT.
Time frame: through study completion, an average o 1 year
Analysis of bone density/attenuation in HU on CT to evaluate the primary endpoint Osteoporosis:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Individual participant dataSharing planned: Undecided
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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.
Andreas M. Fischer, PD Dr. principal investigator
Universitäre Altersmedizin Felix Platter
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 Muscle Loss, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 11 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas M. Fischer, PD Dr. (061 3265102 ext. +41, andreasmfischer.basel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Volume in mm3 on CT (time frame: through study completion, an average o 1 year). 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 NCT06488872, which also lists 1 linked publication.
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 11 Jul 2024.