Sarcopenia and Risk of Fall in Osteoporotic Postmenopausal Women

NCT03382366 | Unknown DMC

• 1 other identifier: Sarcopenia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Falls Patient; Osteoporosis, Postmenopausal

Keywords

Sarcopenia; Risk of fall; Osteoporosis; Muscle; DXA; MR; Muscle metabolism

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 days.

Secondary Outcomes (2)

• Comparison of the fat fraction of the thigh muscle, obtained by RM, between sarcopenic and non-sarcopenic subjects.

  2 days.

• Comparison of risk of fall, evaluated with the use of the OAK device, between sarcopenic and non-sarcopenic subjects.

  2 days.

Study Arms (2)

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.

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.

Diagnostic Test: Blood sampling, risk of fall evaluation, and MR acquisition.

Interventions

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.

Non-sarcopenic Group; Sarcopenic Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• Aged over 60 yo.
• Classified as osteoporotic with t-score = or \< -2,5 evaluated by DXA.
• Autonomous walking.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 20392703 BACKGROUND

• 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.

  PMID: 25539836 BACKGROUND

• 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.

  PMID: 27117135 BACKGROUND

• 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.

  PMID: 28176249 BACKGROUND

• Rubbieri G, Mossello E, Di Bari M. Techniques for the diagnosis of sarcopenia. Clin Cases Miner Bone Metab. 2014 Sep;11(3):181-4.

  PMID: 25568650 BACKGROUND

• 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.

  PMID: 9554417 BACKGROUND

• 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.

  PMID: 11129393 BACKGROUND

• 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.

  PMID: 21549874 BACKGROUND

• 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.

  PMID: 19656816 BACKGROUND

• Dixon WT. Simple proton spectroscopic imaging. Radiology. 1984 Oct;153(1):189-94. doi: 10.1148/radiology.153.1.6089263.

  PMID: 6089263 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jacopo A Vitale, PhD

CONTACT

+39 0266214939; jacopo.vitale@grupposandonato.it

Carmelo Messina, MD

CONTACT

carmelomessina.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 22, 2017
• Study Start: March 29, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

IT (1)