Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

NCT ID: NCT04255173

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis Senile Obesity, Visceral

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Geriatric osteoporotic patients

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.

Group Type EXPERIMENTAL

Body mass index

Intervention Type DIAGNOSTIC_TEST

Body mass index is calculated as a ratio of height and weight, expressed as kg/m2

waist circumference

Intervention Type DIAGNOSTIC_TEST

waist circumference is measured as cm

hip circumference

Intervention Type DIAGNOSTIC_TEST

hip circumference is measured as cm

height

Intervention Type DIAGNOSTIC_TEST

height is measured as cm

Fat percentage

Intervention Type DIAGNOSTIC_TEST

Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan).

Skeletal muscle index

Intervention Type DIAGNOSTIC_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)

Intervention Type DIAGNOSTIC_TEST

ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)

Dual energy x ray absorptiometry (DXA)

Intervention Type 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 assessment

Intervention Type DIAGNOSTIC_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).

Interventions

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Body mass index

Body mass index is calculated as a ratio of height and weight, expressed as kg/m2

Intervention Type DIAGNOSTIC_TEST

waist circumference

waist circumference is measured as cm

Intervention Type DIAGNOSTIC_TEST

hip circumference

hip circumference is measured as cm

Intervention Type DIAGNOSTIC_TEST

height

height is measured as cm

Intervention Type DIAGNOSTIC_TEST

Fat percentage

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

Skeletal muscle index

Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height \[m2\].

Intervention Type DIAGNOSTIC_TEST

A body shape index (ABSI)

ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Bilinç Doğruöz Karatekin

MD, Research Assistant of PMR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IMU OP

Identifier Type: -

Identifier Source: org_study_id

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