- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05352295
Evaluation of the Effects of Covid 19 Infection on Bone Remodeling and Bone Fragility (CovidBone)
Study Overview
Status
Detailed Description
The biological markers under study ( RANKL, OPG, RAGE) will be determined:
- The determinations will be performed on blood samples performed as part of the checks conducted in the normal diagnostic flow and using the residual material not used for routine diagnostics.
Clinical investigations of bone fragility:
- Radiographic investigations performed routinely (pre-operative and immediate post-operative)
Laboratory tests required by clinical routine:
- Pre-operative: blood count, coagulation
- First post-operative sampling (1 post-operative day): complete blood count, coagulation
- Second post-operative sampling, if performed (3 postoperative day +/- 1 day): blood count and coagulation or each evaluated parameter, the following will be calculated:
- descriptive statistics (mean, standard deviation for variables with normal distribution, median and range for variables not normally distributed)
- differences between the two populations (Covid19 positive and Covid19 negative) by means of parametric or non-parametric tests based on the normality of the distribution of values
- sensitivity, specificity positive and negative predictive values, likelihood ratio for each test and for a combination of them Statistical analyzes will be performed using the GraphPad Prism V.5.03 computer package for Windows (GraphPad Software, San Diego, CA, www.graphpad.com).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sara Zacchetti
- Email: sara.zacchetti@grupposandonato.it
Study Contact Backup
- Name: Elena Cittera
- Phone Number: +39 0266214048
- Email: elena.cittera@grupposandonato.it
Study Locations
-
-
-
Milano, Italy
- Recruiting
- Istituto Ortopedico Galeazzi
-
Contact:
- Giuseppe Peretti, MdPhD
- Email: giuseppe.peretti@unimi.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 80 samples of patients from the IRCCS Galeazzi Orthopedic Institute for fracture, divided into two groups:
- 40 with Covid 19 infection confirmed by nasal pharyngeal swab in the course of patients' clinical routine
- 40 without Covid 19 infection confirmed by nasal pharyngeal swab in the course of patients' clinical routine
Description
Inclusion Criteria:
age greater than or equal to 50 years
- patients in the emergency room for fracture of the proximal femur
- subjects of both sexes
- pathologies related to bone fragility (osteoporosis, fractures, parathyroid pathologies).
- signature of the informed consent
- having performed the nasopharyngeal swab for clinical practice to check for SARS Cov2 infection
Exclusion Criteria:
- previous conditions of hypovitaminosis D
- steroid therapy
- Presence of autoimmune diseases or that can create alterations in the inflammatory response
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
infected
40 patients admitted to the IRCCS Galeazzi Orthopedic Institute for fracture with Covid 19 infection ascertained by nasal pharyngeal swab during the patients' clinical routine
|
not infected ( control)
40 patients admitted to the IRCCS Galeazzi Orthopedic Institute for fracture without Covid 19 infection ascertained by nasal pharyngeal swab during the patients' clinical routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RANKL/OPG ratio difference in Covid infected patients
Time Frame: Pre-operative: CBC, coagulation or First post-operative collection (1 post-operative day): CBC, coagulation or Second post-operative collection, if performed (3 postoperative day +/- 1 day): CBC and coagulation
|
Evaluation of any alteration in bone remodeling and increase in bone fragility resulting from Covid19 infection evaluated by means of the RANKL / OPG ratio, an osteoimmunological indicator of bone fragility, measured pre-operative and in the third postoperative day.
|
Pre-operative: CBC, coagulation or First post-operative collection (1 post-operative day): CBC, coagulation or Second post-operative collection, if performed (3 postoperative day +/- 1 day): CBC and coagulation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giuseppe Peretti, MD PhD, Istituto Ortopedico Galeazzi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CovidBone
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Remodeling Bone Fragility Resulting From Covid19
-
GreenBone Ortho S.p.A.RecruitingSurgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic InjuryUnited Kingdom, Germany
-
InSightecTerminatedPain Resulting From Bone MetastasesUnited States
-
Institut National de la Santé Et de la Recherche...Unknown
-
University of CopenhagenRigshospitalet, Denmark; Glostrup University Hospital, Copenhagen; The Novo Nordisk...CompletedBone RemodelingDenmark
-
Saint-Joseph UniversityUnknownDental Implantation | Bone RemodelingLebanon
-
Saint-Joseph UniversityCompletedDental Implantation | Tooth Extraction | Bone RemodelingLebanon
-
Assiut UniversityNot yet recruitingFragility Fracture
-
West Kazakhstan Medical UniversityRecruitingChild Development | Genetic Change | Bone Remodeling DisorderKazakhstan
-
Ildeu Andrade Jr.CompletedLaser Therapy | Bone Remodeling | Orthodontic Tooth MovementBrazil
-
Shanghai Ninth People's Hospital Affiliated to...National Natural Science Foundation of China; Shanghai Municipal Science and... and other collaboratorsCompletedDental Implants | Sinus Floor Augmentation | Bone RemodelingChina