Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
NCT ID: NCT04730622
Last Updated: 2025-05-18
Study Results
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Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2020-11-23
2025-12-31
Brief Summary
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Detailed Description
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The diagnostic workup currently recommended to establish the severity of osteosarcopenia is hard to implement in individuals who arrive at the orthopedic emergency department with a fragility fracture. On the one hand, the evaluation of motility and physical performance is impracticable in bedridden patients; on the other hand, the surgical treatment priority does not allow performing all the instrumental investigations required for a proper diagnosis. In this context, reliable osteosarcopenia biomarkers could help identify most frail patients and plan for them personalized therapeutic interventions to promote postoperative recovery and reduce the risk of adverse outcomes.
Based on the new knowledge on the pathophysiology of osteosarcopenia, the investigators designed a small-scale study that aims to preliminarily verify the adequacy of a set of clinical and laboratory parameters that could be easily applied in hospitalized patients undergoing hip replacement for a fragility fracture. In particular, the investigators planned to assess the following:
* muscle performance by SARC-F questionnaire (acronym deriving from five domains considered in the questionnaire, i.e., strength, assistance with walking, rising from a chair, climbing stairs, and falls);
* dietary habits through a questionnaire on the intake frequency of food categories;
* histological features of osteoporosis and sarcopenia in tissue samples taken from the surgical site;
* the serum levels of markers associated with muscle-bone cross-talk (Myostatin, Insulin-like growth factor 1);
* the serum levels of the following pro-inflammatory cytokines to get a clearer picture of the presence of the inflammatory state: IL-6, IL-8, TNF-α;
* the serum levels of markers such as FGF-21, GDF15, soluble ST2, interesting markers of bone metabolism, indicators of bone mineral density, and modulators of osteoblast-osteoclast activity;
* the composition of the gut microbiota.
The study includes 100 patients who are candidates for hip replacement surgery (endo- and arthroplasty). As the decrease in muscle function and bone quality is more severe in fragility fractures than in osteoarthritis, the investigators expect to find differences in laboratory and clinical parameters.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fragility fracture
Patients who are candidates for hip replacement surgery (endo- and arthroplasty).
SARC-F questionnaire
Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.
Bone tissue histology
Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
Muscle tissue histology
Assessment of histomorphology and ultrastructure of muscle biopsies taken from the upper portion of the vastus lateralis muscle, which is accessed in the surgical procedure of hip replacement.
Myostatin serum levels
Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
Insulin-like growth factor 1 (IGF-1) serum levels
Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
Frequency food questionnaire
Assessment of dietary habits based on self-reported information about the monthly- weekly- or daily-frequency consumption of main food groups, including cereals and bread, meat, fish, fruit, vegetable, legumes, dairy products, sweets and snacks, drinks, and dietary supplements.
Gut microbiota profiling
Assessment of gut microbiome composition on stool samples.
Interventions
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SARC-F questionnaire
Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.
Bone tissue histology
Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
Muscle tissue histology
Assessment of histomorphology and ultrastructure of muscle biopsies taken from the upper portion of the vastus lateralis muscle, which is accessed in the surgical procedure of hip replacement.
Myostatin serum levels
Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
Insulin-like growth factor 1 (IGF-1) serum levels
Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
Frequency food questionnaire
Assessment of dietary habits based on self-reported information about the monthly- weekly- or daily-frequency consumption of main food groups, including cereals and bread, meat, fish, fruit, vegetable, legumes, dairy products, sweets and snacks, drinks, and dietary supplements.
Gut microbiota profiling
Assessment of gut microbiome composition on stool samples.
Eligibility Criteria
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Inclusion Criteria
* Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).
Exclusion Criteria
* Previous prosthetic surgery for orthopedic diseases
* Pre-existing clinical conditions that led to permanent immobility
* Neoplastic diseases
* Autoimmune diseases
* Severe myopathies
* Chronic viral infections (HBV, HCV, HIV);
* Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin
* Paget's disease
65 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Nicola Baldini, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Bologna, Istituto Ortopedico Rizzoli
Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Kirk B, Zanker J, Duque G. Osteosarcopenia: epidemiology, diagnosis, and treatment-facts and numbers. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):609-618. doi: 10.1002/jcsm.12567. Epub 2020 Mar 22.
Wong RMY, Wong H, Zhang N, Chow SKH, Chau WW, Wang J, Chim YN, Leung KS, Cheung WH. The relationship between sarcopenia and fragility fracture-a systematic review. Osteoporos Int. 2019 Mar;30(3):541-553. doi: 10.1007/s00198-018-04828-0. Epub 2019 Jan 4.
Kirk B, Al Saedi A, Duque G. Osteosarcopenia: A case of geroscience. Aging Med (Milton). 2019 Sep 8;2(3):147-156. doi: 10.1002/agm2.12080. eCollection 2019 Sep.
Other Identifiers
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OsteoSarcopenia
Identifier Type: -
Identifier Source: org_study_id
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