NCT04730622 Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
| NCT ID | NCT04730622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteoporotic Fracture of Femur |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-11-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-11-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Nicola Baldini, M.D.
PRINCIPAL INVESTIGATOR
University of Bologna, Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT04730622 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Osteoporotic Fracture of Femur. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04730622 currently recruiting?
Yes, NCT04730622 is actively recruiting participants. Contact the research team at gemma.dipompo@ior.it for enrollment information.
Where is the NCT04730622 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT04730622 clinical trial?
NCT04730622 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Nicola Baldini, M.D. at University of Bologna, Istituto Ortopedico Rizzoli. The trial plans to enroll 100 participants.