Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Osteoarthritis, Hip

Osteoporotic Fracture of Femur

Treatments

Other: Gut microbiota profiling

Diagnostic Test: Muscle tissue histology

Diagnostic Test: SARC-F questionnaire

Diagnostic Test: Bone tissue histology

Diagnostic Test: Myostatin serum levels

Diagnostic Test: Insulin-like growth factor 1 (IGF-1) serum levels

Other: Frequency food questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04730622

OsteoSarcopenia

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who came to observation with femoral neck fracture of possible osteoporotic nature (no or minimal trauma) to be treated with endoprosthesis or hip arthroplasty.
Competent patients who have signed consent to participate in the study (see Informed Consent section of this protocol).

Exclusion criteria

Previous osteoporotic fractures
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