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OsteoporosisQUSNCT04691869

Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis

A study testing Achilles EXPII in people with Osteoporosis and Bone Loss, run by Cedars-Sinai Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Osteoporosis, Bone Loss
What is being tested?
Achilles EXPII
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2022to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • At least 65 years of age (DXA scan is not covered until 65 years of age)
  • Presents with pelvic or extremity fracture(s) to the hospital

Who cannot join

  • Previous diagnosis of osteoporosis with active treatment
  • Multi-system injury patients (eg: brain, thoracic, spine, and intrabdominal)
  • Patients with a pre-existing condition of advanced dementia
  • Patients who lack the capacity to consent
  • If a patient is unable to consent in English

About this study

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.

Read the 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 (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.

Being tested
Achilles EXPII
Medical subject headings
Osteoporosis, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Achilles EXPIIDevice

    Portable ultrasound machine that measures a patient's bone density at the calcaneus.

Study groups in NCT04691869
Study groupRoleWhat they receive
ControlNo interventionPatients will be randomized into a control group and study group. The control group will receive an informational discussion with the nurse-practitioner regarding steps to reduce the risk for osteoporosis, as well as an informational handout in their discharge papers.
InterventionalExperimentalThe study group will undergo the QUS (performed by a member of the study team) and receive the same informational discussion and handouts, with the addition of a QUS screening to take to their follow-up appointment. The QUS screening will come with a half-page description, describing the screening and what their results mean. A discussion lead by the nurse-practitioner, who is a member of the study staff, regarding the results will happen prior to discharge.
Receives: Device: Achilles EXPII

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Osteoporosis Care

    Percent of patients who follow-up within 3 months with a primary care physician, geriatrician, rheumatologist or an endocrinologist to discuss osteoporosis care.

    Measured: Up to 3 months after patient enrollment in study

Secondary outcomes (2)
  1. DXA Scan within 6 months after patient follows-up with physician, geriatrician, rheumatologist or an endocrinologist

    Percent of patients who follow-up within 6 months receive a DXA scan.

    Measured: Up to 6 months after patient follow up in study

  2. Percent of patients prescribed pharmacological therapy for bone health treatment who received a DXA scan and were diagnosed with osteoporosis

    For patients who received a DXA scan and were then diagnosed with osteoporosis, what percent of patients those were prescribed pharmacological treatment for bone health.

    Measured: At the time of DXA scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2020
  2. Study startAug 2022 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Why it stopped: We were not able to complete the study due to COVID restrictions and never enrolled any participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04691869
Sponsor's protocol ID
STUDY00000291
Acronym
QUS
Status last verified
Mar 2022
First submitted
9 Dec 2020
Last updated
4 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Achilles EXPII in people with Osteoporosis and Bone Loss, run by Cedars-Sinai Medical Center.

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 5 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: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Osteoporosis Care (time frame: Up to 3 months after patient enrollment in study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Apr 2022.

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