Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Completed
CT.gov ID
NCT04255173
Collaborator
(none)
571
1
1
23
24.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
571 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Diagnostic Test: waist circumference
waist circumference is measured as cm

Diagnostic Test: hip circumference
hip circumference is measured as cm

Diagnostic Test: height
height is measured as cm

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).

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

Diagnostic Test: A body shape index (ABSI)
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)

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.

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).

Outcome Measures

Primary Outcome Measures

  1. Waist circumference [2 years]

    calculated as cm

  2. Hip circumference [2 years]

    calculated as cm

  3. Fat percentage [2 years]

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

  4. Skeletal muscle index [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]

  5. A body shape index (ABSI) [2 years]

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

Secondary Outcome Measures

  1. The Rapid Assessment of Physical Activity (RAPA) aerobic assessment [2 years]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department Istanbul Turkey 34732

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT04255173
Other Study ID Numbers:
  • IMU OP
First Posted:
Feb 5, 2020
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bilinç Doğruöz Karatekin, MD, Research Assistant of PMR, Istanbul Medeniyet University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2020