Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Primary Purpose
Osteoporosis Senile, Obesity, Visceral
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Body mass index
waist circumference
hip circumference
height
Fat percentage
Skeletal muscle index
A body shape index (ABSI)
Dual energy x ray absorptiometry (DXA)
The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis Senile focused on measuring osteoporosis, anthropometrics, body composition
Eligibility Criteria
Inclusion Criteria:
- being at or over the age of 65
- diagnosed with osteoporosis according to WHO criteria
Exclusion Criteria:
- 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
Sites / Locations
- Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Geriatric osteoporotic patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Waist circumference
calculated as cm
Hip circumference
calculated as cm
Fat percentage
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan)
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]
A body shape index (ABSI)
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04255173
First Posted
February 2, 2020
Last Updated
February 2, 2020
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT04255173
Brief Title
Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Official Title
Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Senile, Obesity, Visceral
Keywords
osteoporosis, anthropometrics, body composition
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
571 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geriatric osteoporotic patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Body mass index
Intervention Description
Body mass index is calculated as a ratio of height and weight, expressed as kg/m2
Intervention Type
Diagnostic Test
Intervention Name(s)
waist circumference
Intervention Description
waist circumference is measured as cm
Intervention Type
Diagnostic Test
Intervention Name(s)
hip circumference
Intervention Description
hip circumference is measured as cm
Intervention Type
Diagnostic Test
Intervention Name(s)
height
Intervention Description
height is measured as cm
Intervention Type
Diagnostic Test
Intervention Name(s)
Fat percentage
Intervention Description
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan).
Intervention Type
Diagnostic Test
Intervention Name(s)
Skeletal muscle index
Intervention Description
Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2].
Intervention Type
Diagnostic Test
Intervention Name(s)
A body shape index (ABSI)
Intervention Description
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual energy x ray absorptiometry (DXA)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
Intervention Description
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).
Primary Outcome Measure Information:
Title
Waist circumference
Description
calculated as cm
Time Frame
2 years
Title
Hip circumference
Description
calculated as cm
Time Frame
2 years
Title
Fat percentage
Description
Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan)
Time Frame
2 years
Title
Skeletal muscle index
Description
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]
Time Frame
2 years
Title
A body shape index (ABSI)
Description
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
Description
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).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being at or over the age of 65
diagnosed with osteoporosis according to WHO criteria
Exclusion Criteria:
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
Facility Information:
Facility Name
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
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