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

Primary Purpose

Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood sampling, risk of fall evaluation, and MR acquisition.
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Risk of fall, Osteoporosis, Muscle, DXA, MR, Muscle metabolism

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • IRCCS Istituto Ortopedico GaleazziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sarcopenic Group

Non-sarcopenic Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 4, 2017
Last Updated
July 16, 2018
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT03382366
Brief Title
Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women
Acronym
Sarcopenia
Official Title
Sarcopenia and Risk of Fall in Elder Post-menopausal Osteoporotic Women: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal
Keywords
Sarcopenia, Risk of fall, Osteoporosis, Muscle, DXA, MR, Muscle metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenic Group
Arm Type
Other
Arm 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.
Arm Title
Non-sarcopenic Group
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sampling, risk of fall evaluation, and MR acquisition.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 days.
Title
Association between sarcopenia, meant as the Appensicular Skeletal Muscle Mass Index (ASMMI) obtained by DXA, and risk of fall evaluated through the OAK device.
Description
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.
Time Frame
2 days.
Secondary Outcome Measure Information:
Title
Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects.
Description
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.
Time Frame
2 days.
Title
Comparison of risk of fall, evaluated with the use of the OAK device, between sarcopenic and non-sarcopenic subjects.
Description
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.
Time Frame
2 days.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacopo A Vitale, PhD
Phone
+39 0266214939
Email
jacopo.vitale@grupposandonato.it
First Name & Middle Initial & Last Name or Official Title & Degree
Carmelo Messina, MD
Email
carmelomessina.md@gmail.com
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacopo A Vitale, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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20392703
Citation
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Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women

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