Osteoporotic Fracture of FemurNCT04730622
Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
An observational study of Osteoporotic Fracture of Femur and Osteoarthritis, Hip, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporotic Fracture of Femur, Osteoarthritis, Hip
- What is being tested?
- SARC-F questionnaire, Bone tissue histology and Muscle tissue histology
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).
Who may be able to join
- 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).
Who cannot join
- Previous osteoporotic fractures
- Previous prosthetic surgery for orthopedic diseases
- Pre-existing clinical conditions that led to permanent immobility
- Neoplastic diseases
- Autoimmune diseases
- Severe myopathies
Show all 9Show fewer
- Chronic viral infections (HBV, HCV, HIV);
- Chronic treatment with anti-osteoporotic drugs, immunosuppressive drugs, and insulin
- Paget's disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Nicola Baldini, M.D., +39 051 6366560, nicola.baldini@ior.it
Alberto C Di Martino, M.D.
About this study
Official title: Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
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.
Read the 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.
- Being tested
- SARC-F questionnaire, Bone tissue histology, Muscle tissue histology, Myostatin serum levels, Insulin-like growth factor 1 (IGF-1) serum levels
- Keywords
- Osteoporosis, Sarcopenia, Hip prosthesis
- Medical subject headings
- Osteoarthritis, Hip, Osteoporosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARC-F questionnaireDiagnostic test
Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.
Bone tissue histologyDiagnostic test
Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
Muscle tissue histologyDiagnostic test
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.
Myostatin serum levelsDiagnostic test
Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
Insulin-like growth factor 1 (IGF-1) serum levelsDiagnostic test
Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
Frequency food questionnaireOther
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.
Gut microbiota profilingOther
Assessment of gut microbiome composition on stool samples.
| Study group | Role | What they receive |
|---|---|---|
| Fragility fracture | Patients who are candidates for hip replacement surgery (endo- and arthroplasty). Receives: Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Bone tissue histology; Diagnostic Test: Muscle tissue histology; Diagnostic Test: Myostatin serum levels; Diagnostic Test: Insulin-like growth factor 1 (IGF-1) serum levels; Other: Frequency food questionnaire; Other: Gut microbiota profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the SARC-F questionnaire
The number of patients able to provide answers divided by the total number of enrolled patients.
Measured: Within 24 hours of admission
Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis)
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit a positive SARC-F questionnaire.
The SARC-F is positive and indicates potential sarcopenia if the score point is = or > 4. For each component of the questionnaire (grip strength, assistance with walking, rising from a chair, climbing stairs, and falls), the score may be 0 (no difficulty; no falls), 1 (some difficulty), and 2 (a lot of difficulties and falls). The total score may range from 0 to 10.
Measured: Within 24 hours of admission
Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis)
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of osteoporotic bone.
The presence of osteoporotic bone will be proved based on the following histological features: loss of connected trabecular bone, altered matrix mineralization, the prevalence of adipose tissue compared to bone marrow, presence of osteoclasts.
Measured: Through study completion, an average of 1 year.
Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of muscle atrophy.
The presence of muscle atrophy will be proved based on the following histological features: decrease in size and number of type II myofibers, presence of necrosis or fibro-adipose replacement, decrease in satellite cell number.
Measured: Through study completion, an average of 1 year.
Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)
The immunoenzymatic quantification of circulating Myostatin (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
Measured: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis)
The immunoenzymatic quantification of circulating IGF-1 (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
Measured: Through study completion, an average of 1 year.
Acceptability of the Frequency Food Questionnaire
The number of patients able to provide answers divided by the total number of enrolled patients.
Measured: Within 24 hours of admission
Frequency of intake of the different food categories in cases (fragility fractures) and controls (osteoarthritis)
The percentages of cases (fragility fractures) and controls (osteoarthritis) who assume never/rarely or regularly the different food categories.
Measured: Within 24 hours of admission
Secondary outcomes (13)
Frequency of positive SARC-F questionnaire in patients with and without osteoporotic bone
The percentage of patients with and without osteoporotic bone who exhibit a positive (= or > 4) or negative (< 4) SARC-F questionnaire.
Measured: Through study completion, an average of 1 year.
Frequency of positive SARC-F questionnaire in patients with and without muscle atrophy
The percentage of patients with and without muscle atrophy who exhibit a positive (= or > 4) or negative (< 4) SARC-F questionnaire.
Measured: Through study completion, an average of 1 year.
Myostatin serum levels in patients with positive and negative SARC-F questionnaire
Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire.
Measured: Through study completion, an average of 1 year.
Myostatin serum levels in patients with and without osteoporotic bone
Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without osteoporotic bone.
Measured: Through study completion, an average of 1 year.
Myostatin serum levels in patients with and without muscle atrophy
Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy.
Measured: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with positive and negative SARC-F questionnaire
Mean ± standard error of the mean, median, and min-max range of circulating IGF-1 (µg/L) in patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire.
Measured: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without osteoporotic bone
Mean ± standard error of the mean, median, and min-max range of circulating IGF-1 (µg/L) in patients with and without osteoporotic bone.
Measured: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without muscle atrophy
Mean ± standard error of the mean, median, and min-max range of circulating Myostatin (µg/L) in patients with and without muscle atrophy.
Measured: Through study completion, an average of 1 year.
Frequency of intake of the different food categories in patients with positive and negative SARC-F questionnaire
The percentage of patients with positive (= or > 4) and negative (< 4) SARC-F questionnaire who assume never/rarely and regularly the different food categories.
Measured: Within 24 hours of admission
Frequency of intake of the different food categories in patients with and without osteoporotic bone
The percentage of patients with and without osteoporotic bone who assume never/rarely and regularly the different food categories.
Measured: Through study completion, an average of 1 year.
Frequency of intake of the different food categories in patients with and without muscle atrophy
The percentage of patients with and without muscle atrophy who assume never/rarely and regularly the different food categories.
Measured: Through study completion, an average of 1 year.
Inflammatory serum markers
Mean ± standard error of the mean, median, and min-max range of circulating IL-6, IL-8, TNF-α in patients
Measured: Through study completion, an average of 1 year.
Serum markers of bone metabolism
Mean ± standard error of the mean, median, and min-max range of circulating FGF-21, GDF15, ST2 in patients
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start23 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic Fracture of FemurStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Baldini, M.D., Principal investigator, University of Bologna, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730622
- Sponsor's protocol ID
- OsteoSarcopenia
- Status last verified
- May 2026
- First submitted
- 20 Jan 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kirk B, Zanker J, Duque G. Osteosarcopenia: epidemiology, diagnosis, and treatment-facts and numbers. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):609-618. doi: 10.1002/jcsm.12567. Epub 2020 Mar 22.
PubMed 32202056Wong RMY, Wong H, Zhang N, Chow SKH, Chau WW, Wang J, Chim YN, Leung KS, Cheung WH. The relationship between sarcopenia and fragility fracture-a systematic review. Osteoporos Int. 2019 Mar;30(3):541-553. doi: 10.1007/s00198-018-04828-0. Epub 2019 Jan 4.
PubMed 30610245Kirk B, Al Saedi A, Duque G. Osteosarcopenia: A case of geroscience. Aging Med (Milton). 2019 Sep 8;2(3):147-156. doi: 10.1002/agm2.12080. eCollection 2019 Sep.
PubMed 31942528
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Parameters of Bone Fragility and Sarcopenia in Patients Undergoing Surgery for Fracture of the Femoral Neck
- ClinicalTrials.gov ID
- NCT04730622
- Acronym / sponsor ID
- OsteoSarcopenia
- Keywords
- Osteoporosis, Sarcopenia, Hip prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fragility fracture | – | Diagnostic Test: SARC-F questionnaire, Diagnostic Test: Bone tissue histology, Diagnostic Test: Muscle tissue histology, Diagnostic Test: Myostatin serum levels, Diagnostic Test: Insulin-like growth factor 1 (IGF-1) serum levels, Other: Frequency food questionnaire, Other: Gut microbiota profilingPatients who are candidates for hip replacement surgery (endo- and arthroplasty). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (9 listed)
- Previous osteoporotic fractures
- Previous prosthetic surgery for orthopedic diseases
- Pre-existing clinical conditions that led to permanent immobility
- Neoplastic diseases
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARC-F questionnaireAssessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls. | Diagnostic test | Fragility fracture |
| Bone tissue histologyAssessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning. | Diagnostic test | Fragility fracture |
| Muscle tissue histologyAssessment 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 | Fragility fracture |
| Myostatin serum levelsQuantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation. | Diagnostic test | Fragility fracture |
| Insulin-like growth factor 1 (IGF-1) serum levelsQuantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis. | Diagnostic test | Fragility fracture |
| Frequency food questionnaireAssessment 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 | Fragility fracture |
| Gut microbiota profilingAssessment of gut microbiome composition on stool samples. | Other | Fragility fracture |
Primary outcome
Acceptability of the SARC-F questionnaire
Time frame: Within 24 hours of admission
The number of patients able to provide answers divided by the total number of enrolled patients.
Frequency of positive SARC-F questionnaire in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Within 24 hours of admission
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit a positive SARC-F questionnaire. The SARC-F is positive and indicates potential sarcopenia if the score point is = or > 4. For each component of the questionnaire (grip strength, assistance with walking, rising from a chair, climbing stairs, and falls), the score may be 0 (no difficulty; no falls), 1 (some difficulty), and 2 (a lot of difficulties and falls). The total score may range from 0 to 10.
Presence of histological features of osteoporotic bone in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Through study completion, an average of 1 year.
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of osteoporotic bone. The presence of osteoporotic bone will be proved based on the following histological features: loss of connected trabecular bone, altered matrix mineralization, the prevalence of adipose tissue compared to bone marrow, presence of osteoclasts.
Presence of histological features of muscle atrophy in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Through study completion, an average of 1 year.
The percentage of cases (fragility fractures) and controls (osteoarthritis) who exhibit histological features of muscle atrophy. The presence of muscle atrophy will be proved based on the following histological features: decrease in size and number of type II myofibers, presence of necrosis or fibro-adipose replacement, decrease in satellite cell number.
Myostatin serum levels in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Through study completion, an average of 1 year.
The immunoenzymatic quantification of circulating Myostatin (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
Insulin-like growth factor 1 (IGF-1) serum levels in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Through study completion, an average of 1 year.
The immunoenzymatic quantification of circulating IGF-1 (µg/L) will be performed on serum samples obtained from peripheral venous blood. The results will be aggregated as mean ± standard error of the mean, median, and min-max range.
Acceptability of the Frequency Food Questionnaire
Time frame: Within 24 hours of admission
The number of patients able to provide answers divided by the total number of enrolled patients.
Frequency of intake of the different food categories in cases (fragility fractures) and controls (osteoarthritis)
Time frame: Within 24 hours of admission
The percentages of cases (fragility fractures) and controls (osteoarthritis) who assume never/rarely or regularly the different food categories.
13 secondary outcomes
Frequency of positive SARC-F questionnaire in patients with and without osteoporotic bone
Time frame: Through study completion, an average of 1 year.
Frequency of positive SARC-F questionnaire in patients with and without muscle atrophy
Time frame: Through study completion, an average of 1 year.
Myostatin serum levels in patients with positive and negative SARC-F questionnaire
Time frame: Through study completion, an average of 1 year.
Myostatin serum levels in patients with and without osteoporotic bone
Time frame: Through study completion, an average of 1 year.
Myostatin serum levels in patients with and without muscle atrophy
Time frame: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with positive and negative SARC-F questionnaire
Time frame: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without osteoporotic bone
Time frame: Through study completion, an average of 1 year.
Insulin-like growth factor 1 (IGF-1) serum levels in patients with and without muscle atrophy
Time frame: Through study completion, an average of 1 year.
Frequency of intake of the different food categories in patients with positive and negative SARC-F questionnaire
Time frame: Within 24 hours of admission
Frequency of intake of the different food categories in patients with and without osteoporotic bone
Time frame: Through study completion, an average of 1 year.
Frequency of intake of the different food categories in patients with and without muscle atrophy
Time frame: Through study completion, an average of 1 year.
Inflammatory serum markers
Time frame: Through study completion, an average of 1 year.
Serum markers of bone metabolism
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 32202056Kirk B, Zanker J, Duque G. Osteosarcopenia: epidemiology, diagnosis, and treatment-facts and numbers. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):609-618. doi: 10.1002/jcsm.12567. Epub 2020 Mar 22.
- Background: PubMed 30610245Wong RMY, Wong H, Zhang N, Chow SKH, Chau WW, Wang J, Chim YN, Leung KS, Cheung WH. The relationship between sarcopenia and fragility fracture-a systematic review. Osteoporos Int. 2019 Mar;30(3):541-553. doi: 10.1007/s00198-018-04828-0. Epub 2019 Jan 4.
- Background: PubMed 31942528Kirk B, Al Saedi A, Duque G. Osteosarcopenia: A case of geroscience. Aging Med (Milton). 2019 Sep 8;2(3):147-156. doi: 10.1002/agm2.12080. eCollection 2019 Sep.
Related trials for Osteoporotic Fracture of Femur
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingObservational study
Quebec Registry for Atypical Femur Fractures
Atypical Femur Fracture
Active, not recruiting
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Healthy, Osteopenia
RecruitingObservational study
Clinical Validation of BBCT-hip
Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicola Baldini, M.D. principal investigator
University of Bologna, Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Fracture of Femur and Osteoarthritis, Hip, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemma Di Pompo, M.Sc. (+39 0516366748, gemma.dipompo@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the SARC-F questionnaire (time frame: Within 24 hours of admission). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730622, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.