RecruitingNot Applicable

Study of Parameters of Osteosarcopenia in Patients With Hip Fracture

Italy100 participantsStarted 2020-11-23

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability of the SARC-F questionnaire

Timeframe: Within 24 hours of admission

Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Within 24 hours of admission

Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Trial details

NCT IDNCT04730622

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Gemma Di Pompo, M.Sc.

+39 0516366748 gemma.dipompo@ior.it

View on ClinicalTrials.gov More Osteoporotic Fracture of Femur trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Acceptability of the SARC-F questionnaire

Timeframe: Within 24 hours of admission

Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Within 24 hours of admission

Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.

Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis)

Timeframe: Through study completion, an average of 1 year.