Sarcopenia and Risk of Fall in Elder Post-menopausal Osteoporotic Women: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Association between sarcopenia, meant as the Appensicular Skeletal Muscle Mass Index (ASMMI) obtained by DXA, and risk of fall evaluated through the OAK device.
Study Overview
Brief Summary
The main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. Forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by DXA in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. The investigators will collect data on: 1) bone (vitamin D) and muscle (myokines) metabolisms through blood sampling; 2) Risk of fall by the OAK device produced by Khymeia; 3) thigh muscle quality through MR.
Detailed Description
A grave change associated with human ageing is progressive decline in skeletal muscle mass, a downward spiral that may lead to decreased strength and functionality. The term 'sarcopenia' (Greek 'sarx' or flesh + 'penia' or loss) has been proposed to describe this age-related decrease of muscle mass. Sarcopenia represents an impaired state of health with increased risk of falls and fractures, impaired ability to perform activities of daily living, and loss of independence. The imaging technologies used to detect loss of skeletal muscle mass in sarcopenia include: dual X-ray absorptiometry (DXA), magnetic resonance imaging (MR), computed tomography, peripheral quantitative computed tomography, and ultrasound.
The main scope of the present pilot study is to evaluate the possible association between the status of sarcopenia and the risk of fall in osteoporotic postmenopausal women. Forty osteoporotic postmenopausal women, previously (pre-recruitment) classified by DXA in 20 sarcopenic and 20 non-sarcopenic subjects, will be recruited. Data will be collected on: 1) bone (vitamin D) and muscle (myokines) metabolisms through blood sampling; 2) Risk of fall by the OAK device produced by Khymeia; 3) thigh muscle quality through MR.
A secondary outcome is to evaluate the differences in bone and muscle metabolism, risk of fall, and muscle quality between sarcopenic and non-sarcopenic subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged over 60 yo.
- •Classified as osteoporotic with t-score = or < -2,5 evaluated by DXA.
- •Autonomous walking.
- •Signed informed consent.
Exclusion Criteria
- •Aged under 60 yo.
- •Psychiatric disorders.
- •Neurological pathologies.
- •Endocrine disorders.
- •Active cigarettes smoke.
- •Recent bone fractures (6 months)
- •Surgical treatments for orthopedic pathologies (6 months).
- •Pacemaker carrier.
- •Use of drugs influencing bone metabolism or limiting physical function.
Arms & Interventions
Sarcopenic Group
This group is composed by 20 osteoporotic postmenopausal women, previously (pre-recruitment) classified as "sarcopenic" by the DXA.
This group will undergo the same evaluations/intervention of the second group.
Intervention: Blood sampling, risk of fall evaluation, and MR acquisition. (Diagnostic Test)
Non-sarcopenic Group
This group is composed by 20 osteoporotic postmenopausal women, previously (pre-recruitment) classified as "non-sarcopenic" by the DXA.
This group will undergo the same evaluations/intervention of the first group.
Intervention: Blood sampling, risk of fall evaluation, and MR acquisition. (Diagnostic Test)
Outcomes
Primary Outcomes
Association between sarcopenia, meant as the Appensicular Skeletal Muscle Mass Index (ASMMI) obtained by DXA, and risk of fall evaluated through the OAK device.
Time Frame: 2 days.
ASMMI is obtained by DXA and calculated with the following formula: (total grams of lean muscle mass of left and right lower and upper limbs)/height\*height, expressed in meters. The risk of fall will be derived by the final score of the OAK device system. The score range is 0-24. Higher scores represent lower risk of falls.
Association between sarcopenia, meant as the percentage of fat fraction of the thigh muscle evaluated by RM, and risk of fall evaluated through the OAK device.
Time Frame: 2 days.
The fat fraction of the thigh muscle is obtained by RM and expressed in percentage (%) of fat on muscle. The risk of fall will be derived by the final score of the OAK device system. The score range is 0-24. Higher scores represent lower risk of falls.
Secondary Outcomes
- Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects.(2 days.)
- Comparison of risk of fall, evaluated with the use of the OAK device, between sarcopenic and non-sarcopenic subjects.(2 days.)