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Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis (QUS)

Primary Purpose

Osteoporosis, Bone Loss

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Achilles EXPII
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoporosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Interventional

    Arm Description

    Patients 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.

    The 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    December 9, 2020
    Last Updated
    March 23, 2022
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04691869
    Brief Title
    Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis
    Acronym
    QUS
    Official Title
    Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We were not able to complete the study due to COVID restrictions and never enrolled any participants.
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis, Bone Loss

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients 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.
    Arm Title
    Interventional
    Arm Type
    Experimental
    Arm Description
    The 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.
    Intervention Type
    Device
    Intervention Name(s)
    Achilles EXPII
    Intervention Description
    Portable ultrasound machine that measures a patient's bone density at the calcaneus.
    Primary Outcome Measure Information:
    Title
    Osteoporosis Care
    Description
    Percent of patients who follow-up within 3 months with a primary care physician, geriatrician, rheumatologist or an endocrinologist to discuss osteoporosis care.
    Time Frame
    Up to 3 months after patient enrollment in study
    Secondary Outcome Measure Information:
    Title
    DXA Scan within 6 months after patient follows-up with physician, geriatrician, rheumatologist or an endocrinologist
    Description
    Percent of patients who follow-up within 6 months receive a DXA scan.
    Time Frame
    Up to 6 months after patient follow up in study
    Title
    Percent of patients prescribed pharmacological therapy for bone health treatment who received a DXA scan and were diagnosed with osteoporosis
    Description
    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.
    Time Frame
    At the time of DXA scan

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carol Lin, MD
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis

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