Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551155
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Peripheral Mononuclear Cells to Screen Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification Monitoring and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCERN
Brief Summary:
Osteoporosis OP is one of most common age-associated and chronic metabolic bone diseases featured by a decrease of bone mineral density BMD that increases the risk of bone fracturesOP guidelines agree that Dual-X-ray Absorptiometry DXA is the gold standard for BMD assessment but for the different OP stages screening and diagnosis BMD by itself is not an accurate predictor Thus OP is often misdiagnosed Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells PBMCs to maintain or not their in vitro viability IRCCS Istituto Ortopedico Rizzoli European patent n3008470 March 21 2018 for the measurement of the different OP severity levels also considering specific gender related differences
Detailed Description:
Inadequate assessment diagnosis and stratification of patients with bone mass loss can lead to an increased risk of osteoporotic fractures Therefore alternative and advanced methods to support screening and diagnosis of osteoporosis OP are becoming increasingly essential particularly considering specific gender differences In this context evaluating new methods and innovative techniques is a global challenge To address this challenge in 2018 the IRCCS Istituto Ortopedico Rizzoli IOR filed a European patent European Patent No 3008470 March 21 2018 Inventors Fini M Giardino R Salamanna F related to an in vitro method for correlating the vitality of peripheral blood mononuclear cells PBMCs with bone metabolism alterations and OP through simple optical microscope observation Additionally specific gender-related differences have been observed in the number size differentiation time and gene and protein expression profiles of PBMCs from osteoporotic patients of different sexes In this context the purpose of this study is to fully expand and develop the patent filed by IRCCS IOR in 2018 in order to a improve the understanding of the mechanisms of action and observed behavior in PBMCs on which the IOR patent is based b correlate the in vitro behavior of PBMCs with different levels of bone metabolism alteration from osteopenia to fragility fractures c evaluate the correlation between the Dual-X-ray Absorptiometry DXA T-score and other blood factors related to OP parameters related to platelets pro- and anti-inflammatory cytokines lymphocyte subpopulations with the in vitro behavior of PBMCs in the presence of different levels of bone metabolism alteration considering specific gender differences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None