SarcopeniaSarcopeniaNCT03382366
Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women
A study testing Blood sampling, risk of fall evaluation, and MR acquisition. in people with Sarcopenia and Falls Patient, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal
- What is being tested?
- Blood sampling, risk of fall evaluation, and MR acquisition.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female.
- Aged over 60 yo.
- Classified as osteoporotic with t-score = or < -2,5 evaluated by DXA.
- Autonomous walking.
- Signed informed consent.
Who cannot join
- Male.
- Aged under 60 yo.
- Psychiatric disorders.
- Neurological pathologies.
- Endocrine disorders.
- Active cigarettes smoke.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Carmelo Messina, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Jacopo A Vitale, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal
- Being tested
- Blood sampling, risk of fall evaluation, and MR acquisition.
- Keywords
- Sarcopenia, Risk of fall, Osteoporosis, Muscle, DXA, MR, Muscle metabolism
- Medical subject headings
- Sarcopenia, Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling, risk of fall evaluation, and MR acquisition.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic Group | Other | 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. Receives: Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition. |
| Non-sarcopenic Group | Other | 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. Receives: Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start29 Mar 2017
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382366
- Sponsor's protocol ID
- Sarcopenia
- Acronym
- Sarcopenia
- Status last verified
- Jul 2018
- First submitted
- 4 Dec 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23.
PubMed 25539836Sergi G, Trevisan C, Veronese N, Lucato P, Manzato E. Imaging of sarcopenia. Eur J Radiol. 2016 Aug;85(8):1519-24. doi: 10.1016/j.ejrad.2016.04.009. Epub 2016 Apr 14.
PubMed 27117135Tosato M, Marzetti E, Cesari M, Savera G, Miller RR, Bernabei R, Landi F, Calvani R. Measurement of muscle mass in sarcopenia: from imaging to biochemical markers. Aging Clin Exp Res. 2017 Feb;29(1):19-27. doi: 10.1007/s40520-016-0717-0. Epub 2017 Feb 7.
PubMed 28176249Rubbieri G, Mossello E, Di Bari M. Techniques for the diagnosis of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):181-4.
PubMed 25568650Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
PubMed 9554417Roubenoff R, Hughes VA. Sarcopenia: current concepts. J Gerontol A Biol Sci Med Sci. 2000 Dec;55(12):M716-24. doi: 10.1093/gerona/55.12.m716.
PubMed 11129393Cummings-Vaughn LA, Gammack JK. Falls, osteoporosis, and hip fractures. Med Clin North Am. 2011 May;95(3):495-506, x. doi: 10.1016/j.mcna.2011.03.003.
PubMed 21549874Tyson SF, Connell LA. How to measure balance in clinical practice. A systematic review of the psychometrics and clinical utility of measures of balance activity for neurological conditions. Clin Rehabil. 2009 Sep;23(9):824-40. doi: 10.1177/0269215509335018. Epub 2009 Aug 5.
PubMed 19656816Dixon WT. Simple proton spectroscopic imaging. Radiology. 1984 Oct;153(1):189-94. doi: 10.1148/radiology.153.1.6089263.
PubMed 6089263
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Risk of Fall in Elder Post-menopausal Osteoporotic Women: a Pilot Study
- ClinicalTrials.gov ID
- NCT03382366
- Acronym / sponsor ID
- Sarcopenia / Sarcopenia
- Conditions
- Sarcopenia, Falls Patient, Osteoporosis, Postmenopausal
- Keywords
- Sarcopenia, Risk of fall, Osteoporosis, Muscle, DXA, MR, Muscle metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic Group | Other | Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.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. |
| Non-sarcopenic Group | Other | Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female.
- Aged over 60 yo.
- Classified as osteoporotic with t-score = or < -2,5 evaluated by DXA.
- Autonomous walking.
- Signed informed consent.
Key exclusion criteria (10 listed)
- Male.
- Aged under 60 yo.
- Psychiatric disorders.
- Neurological pathologies.
- Endocrine disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Non-sarcopenic Group, Sarcopenic Group |
Primary outcome
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.
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 secondary outcomes
Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 25539836Lourenco RA, Perez-Zepeda M, Gutierrez-Robledo L, Garcia-Garcia FJ, Rodriguez Manas L. Performance of the European Working Group on Sarcopenia in Older People algorithm in screening older adults for muscle mass assessment. Age Ageing. 2015 Mar;44(2):334-8. doi: 10.1093/ageing/afu192. Epub 2014 Dec 23.
- Background: PubMed 27117135Sergi G, Trevisan C, Veronese N, Lucato P, Manzato E. Imaging of sarcopenia. Eur J Radiol. 2016 Aug;85(8):1519-24. doi: 10.1016/j.ejrad.2016.04.009. Epub 2016 Apr 14.
- Background: PubMed 28176249Tosato M, Marzetti E, Cesari M, Savera G, Miller RR, Bernabei R, Landi F, Calvani R. Measurement of muscle mass in sarcopenia: from imaging to biochemical markers. Aging Clin Exp Res. 2017 Feb;29(1):19-27. doi: 10.1007/s40520-016-0717-0. Epub 2017 Feb 7.
- Background: PubMed 25568650Rubbieri G, Mossello E, Di Bari M. Techniques for the diagnosis of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):181-4.
- Background: PubMed 9554417Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
- Background: PubMed 11129393Roubenoff R, Hughes VA. Sarcopenia: current concepts. J Gerontol A Biol Sci Med Sci. 2000 Dec;55(12):M716-24. doi: 10.1093/gerona/55.12.m716.
- Background: PubMed 21549874Cummings-Vaughn LA, Gammack JK. Falls, osteoporosis, and hip fractures. Med Clin North Am. 2011 May;95(3):495-506, x. doi: 10.1016/j.mcna.2011.03.003.
- Background: PubMed 19656816Tyson SF, Connell LA. How to measure balance in clinical practice. A systematic review of the psychometrics and clinical utility of measures of balance activity for neurological conditions. Clin Rehabil. 2009 Sep;23(9):824-40. doi: 10.1177/0269215509335018. Epub 2009 Aug 5.
- Background: PubMed 6089263Dixon WT. Simple proton spectroscopic imaging. Radiology. 1984 Oct;153(1):189-94. doi: 10.1148/radiology.153.1.6089263.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo Messina, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, risk of fall evaluation, and MR acquisition. in people with Sarcopenia and Falls Patient, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacopo A Vitale, PhD (+39 0266214939, jacopo.vitale@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382366, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.