Clinical trial NCT04255173: Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Official title: Anthropometric And Body Composition Measurements Related To Osteoporosis In Geriatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Senile
Obesity, Visceral
Keywords: osteoporosis
anthropometrics
body composition
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 571
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Waist circumference
timeFrame: 2 years
measure: Hip circumference
timeFrame: 2 years
measure: Fat percentage
timeFrame: 2 years
measure: Skeletal muscle index
timeFrame: 2 years
measure: A body shape index (ABSI)
timeFrame: 2 years
Secondary outcomes:
measure: The Rapid Assessment of Physical Activity (RAPA) aerobic assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Study officials:
References: