Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sarcopenia and Risk of Fall in Elder Post-menopausal Osteoporotic Women: a Pilot Study

Conditions
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Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal

Intervention / Treatment
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* Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female. Aged over 60 yo. Classified as osteoporotic with t-score = or < -2,5 evaluated by DXA. Autonomous walking. Signed informed consent. Exclusion Criteria: Male. 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sarcopenic Group<br>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. | Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.<br>* Data will be collected on 1) bone/muscle metabolism through blood sampling, 2) risk of fall through OAK device; 3) muscle quality through MR acquisition.<br>|
| Other: Non-sarcopenic Group<br>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. | Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.<br>* Data will be collected on 1) bone/muscle metabolism through blood sampling, 2) risk of fall through OAK device; 3) muscle quality through MR acquisition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 days. | 
| Association between sarcopenia, meant as the Appensicular Skeletal Muscle Mass Index (ASMMI) obtained by DXA, and risk of fall evaluated through the OAK device. | 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. | 2 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects. | Compare the data collected on the fat fraction of the thigh muscle, obtained by RM and expressed in percentage of fat on muscle, between sarcopenic and non-sarcopenic osteoporotic women. | 2 days. | 
| Comparison of risk of fall, evaluated with the use of the OAK device, between sarcopenic and non-sarcopenic subjects. | The OAK device is an innovative technologic system, based on virtual reality, for the assessment and prevention of risk of fall in the elderly. The OAK device comprises (i) two stabilometric platforms that register the Center of Pressure (CoP) of each limb, (ii) four antennas, responsible for the low intensity magnetic field generation into which the patient will move, (iii) three bars able to detect the body weight loaded by the patient during the exercise accomplishment and (iv) a monitor, through which the patient is able to hear and see the exercises proposed. The subject will be set up with a belt, two gloves and two wrappers, containing passive magnetic sensors which can register subject's motions in real time thanks to the magnetic field generated by the antennas. The fall risk assessment will last about 10 minutes and it will be performed before and after the exercise training. A score regarding the fall risk (low, medium or high risk) of the subject will be collected. | 2 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Risk of fall, Osteoporosis, Muscle, DXA, MR, Muscle metabolism