Clinical trial NCT03382366: Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women
Official title: Sarcopenia and Risk of Fall in Elder Post-menopausal Osteoporotic Women: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Falls Patient
Osteoporosis, Postmenopausal
Keywords: Sarcopenia
Risk of fall
Osteoporosis
Muscle
DXA
MR
Muscle metabolism
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 days.
measure: Association between sarcopenia, meant as the Appensicular Skeletal Muscle Mass Index (ASMMI) obtained by DXA, and risk of fall evaluated through the OAK device.
timeFrame: 2 days.
Secondary outcomes:
measure: Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects.
timeFrame: 2 days.
measure: Comparison of risk of fall, evaluated with the use of the OAK device, between sarcopenic and non-sarcopenic subjects.
timeFrame: 2 days.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
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