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OsteosarcopeniaNCT07519720

An Assessment of Risk Factors for Osteosarcopenia in Older Adults - the Role of Prevention, Lifestyle, Physical Activity and Education.

An observational study of Osteosarcopenia, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of the study is to assess the risk factors for osteosarcopenia in older adults, taking into account physical activity, healthy eating habits and education. During the project, the following will be assessed: bone density, handgrip strength, physical activity, functional physical fitness, the incidence of falls… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Osteosarcopenia
What is being tested?
As part of the study, participants will undergo body composition analysis, bone density testing, and tests of physical fitness and handgrip strength in both the older and younger age groups.
How many people
250 participants
Where
1 sitePoland
Study dates
9 Sep 2025to Dec 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study participants are adults of both sexes from Poland, aged between 20 and 80, with varying levels of physical activity, dietary habits and educational backgrounds.

Who may be able to join

  • people aged 60-80,
  • people who are independent and have no mobility limitations requiring the use of assistive devices (wheelchair, walking frame),
  • people who are mentally alert and show no signs of dementia,
  • people with no current acute medical conditions,
  • people who have given their informed consent to participate in the study.

Who cannot join

  • musculoskeletal injuries that have limited physical ability in the last 3 months,
  • a recent bone densitometry scan using dual-energy X-ray absorptiometry (DXA), carried out within the last 12 months,
  • chronic conditions in an acute phase (e.g. rheumatoid arthritis, advanced-stage diabetes),
  • inability to cooperate, e.g. due to language or cognitive barriers.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Wroclaw University of Health and Sport Sciences, Poland

    Wroclaw

Other trials in Poland

About this study

Official title: Risk Factors for Osteosarcopenia, From a Multidisciplinary Perspective on the Prevention and Treatment of Older Adults, Based on Lifestyle Modifications Including Physical Activity, Healthy Eating Habits and Education.

The aim of the study is to assess the risk factors for osteosarcopenia in older adults, taking into account physical activity, healthy eating habits and education.

During the project, the following will be assessed: bone density, handgrip strength, physical activity, functional physical fitness, the incidence of falls and bone fractures over the last 10 years, and dietary habits. The results of the study will then be compared with those of a younger population.

Conditions
Osteosarcopenia
Being tested
As part of the study, participants will undergo body composition analysis, bone density testing, and tests of physical fitness and handgrip strength in both the older and younger age groups.
Keywords
osteosarcopenia,, bone density, body composition, functional ability, ageing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • As part of the study, participants will undergo body composition analysis, bone density testing, and tests of physical fitness and handgrip strength in both the older and younger age groups.Other

    The study will examine the relationship between the frequency of falls and fractures and the parameters obtained in the studies regarding body composition, muscle strength and functional fitness, as well as age, gender, lifestyle, current levels of physical activity and dietary habits.

Study groups in NCT07519720
Study groupRoleWhat they receive
people aged 60-80The study will involve people aged 60-80 with diverse lifestyles. Groups of older adults will be recruited from Universities of the Third Age, Senior Citizens' Clubs, University Alumni Associations, the Wrocław Senior Citizens' Centre, and through advertisements in the media.
Receives: Other: As part of the study, participants will undergo body composition analysis, bone density testing, and tests of physical fitness and handgrip strength in both the older and younger age groups.
people aged <60The study will involve people under the age of 60 with different lifestyles.
Receives: Other: As part of the study, participants will undergo body composition analysis, bone density testing, and tests of physical fitness and handgrip strength in both the older and younger age groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A bone density scan

    A bone density scan (densitometry) allows for the precise measurement of mineral content (primarily calcium) in bone tissue, enabling the early detection of osteoporosis and osteopenia before a fracture occurs. This is crucial for assessing fracture risk, monitoring the effectiveness of treatment and prevention, particularly in people over the age of 50.

    A Lunar iDXA (dual-energy X-ray absorptiometry - DXA) will be used to perform densitometry tests, as a method for measuring bone mineral density (BMD) in the lumbar spine, the proximal femur and the wrist.

    Measured: Day 1

  2. The body composition test the BIA (Bioelectrical Impedance Analysis) - Body weight

    A body composition analysis using the BIA (Bioelectrical Impedance Analysis) method allows for the determination of key body composition parameters, such as: body weight in kilograms.

    Measured: Day 1

  3. The body composition test the BIA (Bioelectrical Impedance Analysis) - Body fat mass

    A body composition analysis using the BIA (Bioelectrical Impedance Analysis) method allows for the determination of key body composition parameters, such as: body fat mass.

    In body composition analysis using the bioelectrical impedance analysis (BIA) method, the Body Fat Mass parameter is expressed in two main forms:

    Kilograms (kg): This is the absolute mass of body fat. Percentages (%): This is the percentage of fat relative to total body weight, often denoted as BF% (Body Fat).

    Furthermore, in segmental analysis (segmental BIA), analysers may also provide fat mass for specific body parts (e.g. arms, legs, torso) in kilograms (kg).

    Measured: Day 1

  4. The body composition test BIA - visceral fat

    Visceral fat, as measured by bioelectrical impedance analysis (BIA), is most commonly expressed as a numerical value (level) rather than in units of mass or as a percentage.

    Scale (Level): The result is usually given as a number between 1 and 20, 30 or 59, depending on the device manufacturer (e.g. Tanita).

    Normal range: A normal level of visceral fat is usually a result within the range of 1-12.

    Measured: Day 1

  5. The body composition test the BIA (Bioelectrical Impedance Analysis) - Lean Body Mass

    Lean Body Mass (LBM) in body composition analysis using the BIA (bioelectrical impedance analysis) method is expressed in units of mass:

    Kilograms (kg) - the most common unit in devices available in Poland and Europe.

    Additionally, on printouts from BIA analysers, this value is often converted into a percentage of total body weight (%) to facilitate assessment of its composition in relation to fat.

    Measured: Day 1

  6. The body composition test the BIA (Bioelectrical Impedance Analysis) - Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2

    Measured: Day 1

  7. The body composition test the BIA (Bioelectrical Impedance Analysis) - Metabolic age

    Metabolic age in a BIA (bioelectrical impedance analysis) test is expressed in years.

    Range: Devices (e.g. Tanita) typically display a metabolic age ranging from 12 to 90 years.

    Interpretation: This result compares your basal metabolic rate (BMR) with the average chronological age for that value.

    Measured: Day 1

  8. The body composition test the BIA (Bioelectrical Impedance Analysis) - muscule mass

    In body composition analysis using the electrical bioimpedance analysis (BIA) method, muscle mass (or skeletal muscle mass - SMM) is most commonly expressed in the following units:

    Kilograms (kg) - this is the basic unit used to determine the absolute muscle mass in the body.

    Percentages (%) - in many advanced analysers, muscle mass is also presented as a percentage of total body weight.

    Measured: Day 1

  9. The body composition test the BIA (Bioelectrical Impedance Analysis) - Bone mass

    In body composition analysis using the bioelectrical impedance analysis (BIA) method, bone mass is given in kilograms (kg).

    Key information about bone mass measurement in BIA:

    This measurement estimates the mass of bone minerals in the body (however, it is not the same as a DEXA bone density scan).

    Reference ranges: In women, bone mass is usually around 2-3 kg, and in men 2.5-4 kg.

    The result generally reflects the overall health of the skeleton, and a fall below certain values may suggest a risk of osteopenia or osteoporosis.

    Measured: Day 1

  10. The body composition test the BIA (Bioelectrical Impedance Analysis) - the both intracellular (ICW) and extracellular water content (ECW)

    In bioelectrical impedance analysis (BIA) tests, the content of intracellular water (ICW) and extracellular water (ECW) is most commonly expressed in the following units:

    Litres (L) - to determine the absolute volume of fluids. Percentage of body weight (%) - to determine the proportion of water in total body weight.

    Measured: Day 1

  11. Assessment of physical activity using the IPAQ questionnaire

    The International Physical Activity Questionnaire (IPAQ) is a standardized tool used to assess7-day recall of physical activity (walking, moderate-intensity, and vigorous-intensity) and sitting time, available in short (surveillance) and long (detailed research) forms for adults aged 15-69. It calculates activity in MET-min/week to categorize individuals into low, moderate, or high activity.

    Measured: Day 1

  12. The KomPAN Questionnaire (Dietary Habits and Nutrition Beliefs Questionnaire)

    The KomPAN Questionnaire (Dietary Habits and Nutrition Beliefs Questionnaire) This tool was developed by the Behavioural Determinants of Nutrition Team of the Committee on Human Nutrition Sciences at the Polish Academy of Sciences (PAN).

    Purpose: To investigate the dietary beliefs and habits of adult Poles.

    Application: The questionnaire enables the assessment of:

    • the frequency of consumption of various food groups (e.g. vegetables, fruit, meat, sweets).
    • dietary habits (e.g. meal times, snacking).
    • views on nutrition (nutritional knowledge). There are various versions (e.g. 2014, 2016, 2024), allowing the survey to be adapted to current research needs.

    The questionnaire includes a set of questions on the frequency of food consumption (FFQ - Food Frequency Questionnaire).

    Measured: Day 1

  13. The SCREEN II questionnaire (Seniors in the Community: Risk Evaluation for Eating and Nutrition)

    The SCREEN II questionnaire (Seniors in the Community: Risk Evaluation for Eating and Nutrition) This is a Canadian tool that has been validated and is also used in Poland. Purpose: Screening for the risk of malnutrition in older people (aged 60-65 and over) living at home (independently).

    Use: It helps to identify older people at risk of nutritional problems before serious malnutrition occurs.

    It consists of questions concerning:

    changes in body weight, appetite, number of meals, difficulties with eating, and the amount of selected food groups consumed.

    In Poland, it is used, amongst other things, to assess the quality of the diet of senior club members.

    Measured: Day 1

  14. Short Physical Performance Battery - Test: Timed up and go (TUG)

    A tool used to assess the physical fitness of older people in three areas: lower-body strength, static balance and walking speed, handgrip strength assessment.

    The Timed Up and Go (TUG) test is a quick clinical test that assesses functional mobility, dynamic balance and the risk of falls, particularly in older people. It involves measuring the time (in seconds) it takes for the participant to stand up from a chair, walk 3 metres, turn around, walk back and sit down again.

    Measured: Day 1

  15. Short Physical Performance Battery - The 5-Times Sit-to-Stand Test (5XSST)

    A tool used to assess the physical fitness of older people in three areas: e.g. lower-body strength, static balance and walking speed, handgrip strength assessment.

    The 5-Times Sit-to-Stand Test (5XSST) is a simple, functional test of physical fitness that measures the time taken to stand up from a chair five times without using one's hands.

    The aim of the test is to assess lower limb muscle strength, primarily that of the quadriceps, measure functional mobility, assess the ability to perform everyday activities such as standing up from a chair or a car, and assess the risk of falls - a higher score (longer time) is associated with a greater risk of falling in older people.

    A result of less than 12-15 seconds is considered normal for most adults. Risk: A result of over 15 seconds suggests functional limitations and a higher risk of falling, particularly in older people.

    Age: Norms may vary depending on age (e.g. for people aged 80-89, a result of over 14.8 secon

    Measured: Day 1

  16. Short Physical Performance Battery - The test HGS (Hand Grip Strength)

    A tool used to assess the physical fitness of older people in three areas: e.g. lower-body strength, static balance and walking speed, handgrip strength assessment.

    HGS (Hand Grip Strength) tests, which measure hand grip strength, involve the objective measurement of the maximum isometric strength of the finger and hand flexor muscles using a portable device known as a hand dynamometer. It is a simple, quick and non-invasive test that serves as an indicator of overall muscle strength and bodily function, as well as a marker of metabolic health and long life. The test measures and assesses grip strength in kilograms (kg) or pounds (lbs).

    A hand dynamometer (e.g. Jamar) is used for the test, which the subject squeezes. The subject squeezes the device's handle as hard as they can for approximately 3-5 seconds. The measurement is usually repeated 2-3 times for both hands (dominant and non-dominant) with rest intervals, and the highest value obtained is taken as the result.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start9 Sep 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519720
Sponsor's protocol ID
19/2025
Status last verified
May 2025
First submitted
26 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteosarcopenia, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.

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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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 Poland. 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?

This study is still under way. Results are not available in the source record yet.

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?

A bone density scan (time frame: Day 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Apr 2026.

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