Quantitative Ultrasound Use to Increase Geriatric Follow-up for Osteoporosis

NCT04691869 | Withdrawn FDA Device

• 1 other identifier: STUDY00000291
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis; Bone Loss

Outcome Measures

Primary Outcomes (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.

  Up to 3 months after patient enrollment in study

Secondary Outcomes (2)

• DXA Scan within 6 months after patient follows-up with physician, geriatrician, rheumatologist or an endocrinologist

  Up to 6 months after patient follow up in study

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

  At the time of DXA scan

Study Arms (2)

Control

NO INTERVENTION

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.

Interventional

EXPERIMENTAL

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.

Device: Achilles EXPII

Interventions

Achilles EXPII DEVICE

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

Interventional

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carol Lin, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Residency Program Director

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 31, 2020
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03