Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women (Sarcopenia)

July 16, 2018 updated by: Istituto Ortopedico Galeazzi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20161
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Principal Investigator:
          • Jacopo A Vitale, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: Blood sampling, risk of fall evaluation, and MR acquisition.
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.
Other: 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.
Diagnostic test: Blood sampling, risk of fall evaluation, and MR acquisition.
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.

What is the study measuring?

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.
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.
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.
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.
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.
Time Frame: 2 days.
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.
Time Frame: 2 days.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Anticipated)

May 31, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sarcopenia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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