Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691869
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2020-12-09
Brief Title:
Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were not able to complete the study due to COVID restrictions and never enrolled any participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUS
Brief Summary:
The objective of this study is to determine whether patient follow up for osteoporosis is aided using a quantitative ultrasound QUS measurement
Using the QUS measurement could potentially improve osteoporosis follow-up rates and in-office patient measurements have been previously shown to increase compliance with treatment in other conditions Increased compliance with follow-ups and medication recommendations have been shown to decrease fracture rates in patients with osteoporosis
Using the QUS measurement could potentially improve osteoporosis follow-up rates and in-office patient measurements have been previously shown to increase compliance with treatment in other conditions Increased compliance with follow-ups and medication recommendations have been shown to decrease fracture rates in patients with osteoporosis
Detailed Description:
Over 10 million Americans have osteoporosis which is defined as a chronic progressive disease presenting with deterioration of bone tissue and fragility subsequently leading to an increased fracture risk1 A positive diagnosis for osteoporosis is significantly correlated with increased age making geriatrics patients an at-risk group for bone health complications2 A pathophysiological diagnosis for osteoporosis is done radiographically based on bone mineral density from a dual energy x-ray absorptiometry assessment DXA3 DXA scans have been used increasingly over time in geriatric populations to screen patients for osteoporosis4 however one problem with DXA scans is the radiation dose due to x-ray radiography4 Therefore using DXA scans as a preliminary screening method comes with risks even though it is the gold standard for diagnosis3
Osteoporosis is often referred to as a silent disease because people are not aware that they have low bone density9 The first sign may be loss of height but can also be a fracture due to a ground level mechanical fall As people age their bones lose their strength density and become more brittle210 Unfortunately fractures can have devastating effects on peoples quality of life causing chronic pain difficulties with mobility need for increased assistance isolation increased nursing home placement and rates of death10 Also once a person has fallen and had a fragility fracture they are likely to do so again10 Our goal is to encourage older adult patients to follow-up with their doctors to discuss osteoporosis screening diagnosis and treatment to help reduce the prevalence of fragility fractures
Osteoporosis follow-up rates need to be improved in geriatric populations Increased compliance with follow-ups and medication recommendations have been shown to decrease fracture rates in this population5 In-office patient measurements have been previously shown to increase compliance with treatment In the case of smoking carbon monoxide CO monitors increased a patients willingness to comply with cessation protocols significantly in an orthopedic fracture population6
Quantitative ultrasound scans QUS have emerged as a simple point-of-care test for bone density 7 For a quantitative ultrasound scan the patient sits in a chair and places their heel on specialized ultrasound machine in a manner similar to having the size of the foot measured at a department store The machine is portable and can be performed at the bedside Prior research has demonstrated that although QUS cannot replace DXA scans as the gold standard for diagnosis of osteopenia it can still be used to immediately identify abnormal bone density8 Integrating QUS scans into geriatric fracture treatment comes at little risk and similar to home CO monitoring for smoking cessation may provide additional information to the patient to encourage further action
Osteoporosis is often referred to as a silent disease because people are not aware that they have low bone density9 The first sign may be loss of height but can also be a fracture due to a ground level mechanical fall As people age their bones lose their strength density and become more brittle210 Unfortunately fractures can have devastating effects on peoples quality of life causing chronic pain difficulties with mobility need for increased assistance isolation increased nursing home placement and rates of death10 Also once a person has fallen and had a fragility fracture they are likely to do so again10 Our goal is to encourage older adult patients to follow-up with their doctors to discuss osteoporosis screening diagnosis and treatment to help reduce the prevalence of fragility fractures
Osteoporosis follow-up rates need to be improved in geriatric populations Increased compliance with follow-ups and medication recommendations have been shown to decrease fracture rates in this population5 In-office patient measurements have been previously shown to increase compliance with treatment In the case of smoking carbon monoxide CO monitors increased a patients willingness to comply with cessation protocols significantly in an orthopedic fracture population6
Quantitative ultrasound scans QUS have emerged as a simple point-of-care test for bone density 7 For a quantitative ultrasound scan the patient sits in a chair and places their heel on specialized ultrasound machine in a manner similar to having the size of the foot measured at a department store The machine is portable and can be performed at the bedside Prior research has demonstrated that although QUS cannot replace DXA scans as the gold standard for diagnosis of osteopenia it can still be used to immediately identify abnormal bone density8 Integrating QUS scans into geriatric fracture treatment comes at little risk and similar to home CO monitoring for smoking cessation may provide additional information to the patient to encourage further action
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None