NCT04730622

Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck. The control group will consist of patients undergoing a hip replacement for osteoarthritis, as the decrease in muscle function and bone quality is less severe in this condition than in osteoporosis.

Detailed description

Osteoporotic hip fractures (fragility fractures) are common in older adults, and the risk of adverse outcomes and mortality is higher in patients affected by osteosarcopenia, a geriatric syndrome in which the low bone mineral density and bone microarchitecture deterioration (osteopenia/osteoporosis) are combined with a decline in mass, strength, and functional capacity of skeletal muscle (sarcopenia). 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

• Osteoporotic Fracture of Femur
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Bone tissue histology	Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Myostatin serum levels	Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
DIAGNOSTIC_TEST	Insulin-like growth factor 1 (IGF-1) serum levels	Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
OTHER	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.
OTHER	Gut microbiota profiling	Assessment of gut microbiome composition on stool samples.

Timeline

• Start date: 2020-11-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-01-29
• Last updated: 2025-05-18

Locations

1 site across 1 country: Italy