Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Unknown

Conditions: Sarcopenia; Falls Patient; Osteoporosis, Postmenopausal

Treatments: Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.

Study type: Interventional

Funder types: Other

Identifiers

NCT03382366

Sarcopenia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sarcopenic Group

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.

Non-sarcopenic Group

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.