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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

571

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

January 1, 2018

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed

Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

February 2, 2020

Last Update Submit

February 2, 2020

Conditions

Osteoporosis Senile Obesity, Visceral

Keywords

osteoporosisanthropometricsbody composition

Outcome Measures

Primary Outcomes (5)

Waist circumference
calculated as cm
2 years
Hip circumference
calculated as cm
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)
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 \[m2\]
2 years
A body shape index (ABSI)
ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
2 years

Secondary Outcomes (1)

The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
2 years

Study Arms (1)

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.

Diagnostic Test: Body mass indexDiagnostic Test: waist circumferenceDiagnostic Test: hip circumferenceDiagnostic Test: heightDiagnostic Test: Fat percentageDiagnostic Test: Skeletal muscle indexDiagnostic 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