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CompletedNCT04255173Updated Feb 5, 2020

Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

An interventional study of Body mass index and waist circumference in Osteoporosis Senile and Obesity, Visceral, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Istanbul Medeniyet University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2018, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
571
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoporosis Senile
  • Obesity, Visceral

Keywords

  • osteoporosis
  • anthropometrics
  • body composition
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 571 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Istanbul Medeniyet University is the lead sponsor of 188 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • being at or over the age of 65
  • diagnosed with osteoporosis according to WHO criteria

Exclusion 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
571 participants (actual)

Study arms

  • 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 · 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

Interventions

  • Diagnostic testBody mass index

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

  • Diagnostic testwaist circumference

    waist circumference is measured as cm

  • Diagnostic testhip circumference

    hip circumference is measured as cm

  • Diagnostic testheight

    height is measured as cm

  • Diagnostic testFat percentage

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

  • Diagnostic testSkeletal muscle index

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

  • Diagnostic testA body shape index (ABSI)

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

  • Diagnostic testDual 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 testThe 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).

06

What researchers measure

Primary outcomes

  1. Waist circumference

    calculated as cm

    Time frame: 2 years

  2. Hip circumference

    calculated as cm

    Time frame: 2 years

  3. Fat percentage

    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

  4. 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 \[m2\]

    Time frame: 2 years

  5. A body shape index (ABSI)

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

    Time frame: 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).

    Time frame: 2 years

07

Study locations

1 site
  • Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
    Istanbul, 34732, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04255173
Lead sponsor
Istanbul Medeniyet University
Responsible party
Bilinç Doğruöz Karatekin (MD, Research Assistant of PMR, Istanbul Medeniyet University) — Principal investigator
First posted
Feb 5, 2020
Start date
Jan 1, 2018
Primary completion
Nov 1, 2019
Completion
Dec 1, 2019
Last update
Feb 5, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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