Assessing Osteosarcopenia in Patients with Hip Fractures
Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
This study is testing if certain tests can help identify muscle and bone issues in patients with hip fractures to improve their recovery after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04730622 on ClinicalTrials.gov |
What this trial studies
This study evaluates clinical and laboratory parameters to identify osteosarcopenia in patients undergoing hip replacement due to fragility fractures. It compares these patients to those with hip replacements for osteoarthritis, where muscle function and bone quality are less affected. The goal is to find reliable biomarkers that can be easily applied in hospitalized patients to tailor postoperative interventions and improve recovery outcomes. The study will utilize assessments such as the SARC-F questionnaire and serum levels of myostatin and IGF-1.
Who should consider this trial
Good fit: Ideal candidates are older adults presenting with femoral neck fractures of osteoporotic nature who are eligible for hip replacement surgery.
Not a fit: Patients with previous osteoporotic fractures, severe myopathies, or chronic viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of frail patients, improving their recovery and reducing adverse outcomes after hip surgery.
How similar studies have performed: While similar studies have explored osteosarcopenia, this specific approach focusing on hospitalized patients with fragility fractures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Nicola Baldini, M.D. — University of Bologna, Istituto Ortopedico Rizzoli
- Study coordinator: Gemma Di Pompo, M.Sc.
- Email: gemma.dipompo@ior.it
- Phone: +39 0516366748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.