Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women
NCT ID: NCT03382366
Last Updated: 2018-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-03-29
2019-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Aged over 60 yo.
* Classified as osteoporotic with t-score = or \< -2,5 evaluated by DXA.
* Autonomous walking.
* Signed informed consent.
Exclusion Criteria
* 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.
60 Years
FEMALE
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Locations
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IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Countries
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Central Contacts
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References
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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.
Lourenco 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.
Sergi 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.
Tosato 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.
Rubbieri G, Mossello E, Di Bari M. Techniques for the diagnosis of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):181-4.
Baumgartner 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.
Roubenoff 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.
Cummings-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.
Tyson 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.
Dixon WT. Simple proton spectroscopic imaging. Radiology. 1984 Oct;153(1):189-94. doi: 10.1148/radiology.153.1.6089263.
Other Identifiers
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Sarcopenia
Identifier Type: -
Identifier Source: org_study_id
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