Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

Obesity, Visceral Clinical Trial

Official title:

Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255173
• Other study ID #: IMU OP
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Abdominal
• Obesity, Visceral
• Osteoporosis
• Osteoporosis Senile

Intervention

Diagnostic Test:
• Body mass index
Body mass index is calculated as a ratio of height and weight, expressed as kg/m2
• waist circumference
waist circumference is measured as cm
• hip circumference
hip circumference is measured as cm
• height
height is measured 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
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)
• 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.
• 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).

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist circumference	calculated as cm	2 years
Primary	Hip circumference	calculated as cm	2 years
Primary	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
Primary	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
Primary	A body shape index (ABSI)	ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)	2 years
Secondary	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).	2 years