Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04691869 |
Other study ID # |
STUDY00000291 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 2022 |
Est. completion date |
September 2023 |
Study information
Verified date |
March 2022 |
Source |
Cedars-Sinai Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 (DXA)3. 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 brittle2,10. Unfortunately, fractures can have devastating effects on
people's 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 patient's 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.