Osteoporosis SenileNCT04255173
Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
A study testing Body mass index, waist circumference and hip circumference in people with Osteoporosis Senile and Obesity, Visceral, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The patients who consulted to the geriatric outpatient clinic between 2018 and 2019 were included in the study. The inclusion criterions were being at or over the age of 65 and diagnosed with osteoporosis according to WHO criteria. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporosis Senile, Obesity, Visceral
- What is being tested?
- Body mass index, waist circumference and hip circumference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Dec 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- being at or over the age of 65
- diagnosed with osteoporosis according to WHO criteria
Who cannot join
- vertebral fracture due to known accidental traumas
- history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids )
- history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, 34732
About this study
The patients who consulted to the geriatric outpatient clinic between 2018 and 2019 were included in the study. The inclusion criterions were being at or over the age of 65 and diagnosed with osteoporosis according to WHO criteria. Exclusion criteria include vertebral fracture due to known accidental traumas, history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids ), history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases.
Initially, a demographic form including age, sex, comorbidities, weight, height was filled by the participants. Body mass index (BMI, ratio of height and weight, expressed as kg/m2) calculated. Patients waist and hip circumference was measured (cm).
Read more
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2] [8]. ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6) [4].
Osteoporosis was evaluated by using dual energy x-ray absorptiometry (DXA). According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD, b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD.
Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment [9]. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).
The study protocol was approved by the ethics committee (2018/0478) and all participants gave written informed consent.
- Conditions
- Osteoporosis Senile, Obesity, Visceral
- Being tested
- Body mass index, waist circumference, hip circumference, height, Fat percentage
- Keywords
- osteoporosis, anthropometrics, body composition
- Medical subject headings
- Osteoporosis, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body mass indexDiagnostic test
Body mass index is calculated as a ratio of height and weight, expressed as kg/m2
waist circumferenceDiagnostic test
waist circumference is measured as cm
hip circumferenceDiagnostic test
hip circumference is measured as cm
heightDiagnostic test
height is measured as cm
Fat percentageDiagnostic test
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan).
Skeletal muscle indexDiagnostic test
Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2].
A body shape index (ABSI)Diagnostic test
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
Dual energy x ray absorptiometry (DXA)Diagnostic test
Osteoporosis is diagnosed with DXA scores. According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD (standard deviation), b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD.
The Rapid Assessment of Physical Activity (RAPA) aerobic assessmentDiagnostic test
Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).
| Study group | Role | What they receive |
|---|---|---|
| Geriatric osteoporotic patients | Experimental | We measured different anthropometric and body composition measurements as body weight, BMI, percentage body fat, skeletal muscle index (SMI), ABSI, waist (WC) and hip circumference (HC) in geriatric population to investigate the relation to osteoporosis. Receives: Diagnostic Test: Body mass index; Diagnostic Test: waist circumference; Diagnostic Test: hip circumference; Diagnostic Test: height; Diagnostic Test: Fat percentage; Diagnostic Test: Skeletal muscle index; Diagnostic Test: A body shape index (ABSI); Diagnostic Test: Dual energy x ray absorptiometry (DXA); Diagnostic Test: The Rapid Assessment of Physical Activity (RAPA) aerobic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
calculated as cm
Measured: 2 years
Hip circumference
calculated as cm
Measured: 2 years
Fat percentage
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan)
Measured: 2 years
Skeletal muscle index
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2]
Measured: 2 years
A body shape index (ABSI)
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
Measured: 2 years
Secondary outcomes (1)
The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2018
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis SenileStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255173
- Sponsor's protocol ID
- IMU OP
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
- ClinicalTrials.gov ID
- NCT04255173
- Acronym / sponsor ID
- IMU OP
- Conditions
- Osteoporosis Senile, Obesity, Visceral
- Keywords
- osteoporosis, anthropometrics, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Feb 2020 (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 patients who consulted to the geriatric outpatient clinic between 2018 and 2019 were included in the study. The inclusion criterions were being at or over the age of 65 and diagnosed with osteoporosis according to WHO criteria. Exclusion criteria include vertebral fracture due to known accidental traumas, history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids ), history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases.
Initially, a demographic form including age, sex, comorbidities, weight, height was filled by the participants. Body mass index (BMI, ratio of height and weight, expressed as kg/m2) calculated. Patients waist and hip circumference was measured (cm).
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2] [8]. ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6) [4].
Osteoporosis was evaluated by using dual energy x-ray absorptiometry (DXA). According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD, b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD.
Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment [9]. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).
The study protocol was approved by the ethics committee (2018/0478) and all participants gave written informed consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric osteoporotic patients | Experimental | Diagnostic Test: Body mass index, Diagnostic Test: waist circumference, Diagnostic Test: hip circumference, Diagnostic Test: height, Diagnostic Test: Fat percentage, Diagnostic Test: Skeletal muscle index, Diagnostic Test: A body shape index (ABSI), Diagnostic Test: Dual energy x ray absorptiometry (DXA), Diagnostic Test: The Rapid Assessment of Physical Activity (RAPA) aerobic assessmentWe measured different anthropometric and body composition measurements as body weight, BMI, percentage body fat, skeletal muscle index (SMI), ABSI, waist (WC) and hip circumference (HC) in geriatric population to investigate the relation to osteoporosis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- being at or over the age of 65
- diagnosed with osteoporosis according to WHO criteria
Key exclusion criteria (3 listed)
- vertebral fracture due to known accidental traumas
- history of drug therapy in the past year (biphosphonate, estrogen replacement therapy, glucocorticoids )
- history of co-morbidities as malignancy, radiotherapy or chemotherapy, renal failure, hyperthyroidism, primer hyperparathyroidism, rheumatic disease or adrenal diseases
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 |
|---|---|---|
| Body mass indexBody mass index is calculated as a ratio of height and weight, expressed as kg/m2 | Diagnostic test | Geriatric osteoporotic patients |
| waist circumferencewaist circumference is measured as cm | Diagnostic test | Geriatric osteoporotic patients |
| hip circumferencehip circumference is measured as cm | Diagnostic test | Geriatric osteoporotic patients |
| heightheight is measured as cm | Diagnostic test | Geriatric osteoporotic patients |
| Fat percentageFat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). | Diagnostic test | Geriatric osteoporotic patients |
| Skeletal muscle indexSkeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2]. | Diagnostic test | Geriatric osteoporotic patients |
| A body shape index (ABSI)ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6) | Diagnostic test | Geriatric osteoporotic patients |
| Dual energy x ray absorptiometry (DXA)Osteoporosis is diagnosed with DXA scores. According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD (standard deviation), b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD. | Diagnostic test | Geriatric osteoporotic patients |
| The Rapid Assessment of Physical Activity (RAPA) aerobic assessmentPhysical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active). | Diagnostic test | Geriatric osteoporotic patients |
Primary outcome
Waist circumference
Time frame: 2 years
calculated as cm
Hip circumference
Time frame: 2 years
calculated as cm
Fat percentage
Time frame: 2 years
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan)
Skeletal muscle index
Time frame: 2 years
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan). Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2]
A body shape index (ABSI)
Time frame: 2 years
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
1 secondary outcome
The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
Time frame: 2 years
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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?
A study testing Body mass index, waist circumference and hip circumference in people with Osteoporosis Senile and Obesity, Visceral, run by Istanbul Medeniyet 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 5 Feb 2020. 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?
Waist circumference (time frame: 2 years). The study lists 5 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 5 Feb 2020.