Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device

NCT07187518 | Recruiting

• 2 other identifiers: R4C-BMD-0113GW0807
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break. Osteoporosis and bone fracture risk are currently evaluated by looking at clinical risk factors and measuring bone mineral density (BMD). The lower the BMD is, the higher the risk of osteoporotic fractures in the future. An X-ray device called DXA is the main tool used to diagnose osteoporosis and fracture risk clinically. DXA measures two-dimensional BMD in the hip and spine. However, DXA devices are often not readily available at the point of care. The POROUS ultrasound device offers a different approach by measuring various properties of the outer layer of the bone in the lower leg. It has several advantages over DXA: (1) higher and three-dimensional image resolution; (2) the ability to measure bone properties without radiation; (3) portability, it is a mobile medical device; 4) lower operational costs. For this clinical study, we will recruit men and women between the ages of 21 and 55. Most of these study participants will not have evident clinical risks for osteoporosis. The goal for including this age group is to estimate the range of BMD values for younger people before BMD declines with age. In a separate clinical study, we are recruiting older participants. The study is anticipated to last one year. Our major research questions are:

• Can the POROUS ultrasound device estimate BMD?
• How does its performance compare to DXA?
• What is the safety of the new device? The participants will:
• answer questions about their medical history.
• be measured for height and weight.
• be examined with the two devices, DXA and POROUS.

Conditions

Healthy; Osteopenia; Osteoporosis

Keywords

Osteoporosis; Osteopenia; Bone Tissue; Diagnostic Imaging; Ultrasound; Ultrasonography; Ultrasonic Diagnosis; DEXA Scan; DXA Scan; Dual X-Ray Absorptiometry; Bone Fractures; Osteoporotic Fractures; Hip Fractures; Spinal Fractures; Bone Mineral Density

Outcome Measures

Primary Outcomes (2)

• Primary Clinical Endpoint - POROUS

  Assessment of the POROUS R4C ultrasound device in estimating surrogate aBMD values (total femur). The primary endpoint aims to obtain a statistically significant correlation between the surrogate POROUS-aBMD values and the respective DXA-aBMD values (total femur). Outcome measure: POROUS-aBMD (g/cm\^2).

  12 months

• Primary Clinical Endpoint - DXA

  Outcome measure: DXA-aBMD values - total femur (g/cm\^2)

  12 months

Secondary Outcomes (3)

• Secondary Clinical Endpoint - POROUS

  12 months

• Secondary Clinical Endpoint - DXA

  12 months

• Safety Endpoint: Incidence of procedural/device-related adverse events

  12 months

Other Outcomes (19)

• Cortical bone properties: ultrasound cortical sound velocity in the radial direction

  12 months

• Cortical bone properties: cortical thickness

  12 months

• Cortical bone properties: ultrasound frequency-dependent attenuation coefficient

  12 months

Study Arms (1)

BMD estimation in young and middle-aged men and women

EXPERIMENTAL

All participants are examined with the investigational device (POROUS R4C ultrasound device) and a comparator device (DXA).

Device: Measurements with the POROUS R4C ultrasound device at the midshaft tibia; Device: DXA measurement of the hip and lumbar spine

Interventions

Measurements with the POROUS R4C ultrasound device at the midshaft tibia DEVICE

The POROUS R4C ultrasound device measures the cortical bone of the midshaft tibia. Ultrasound gel is first applied onto the skin surface, covering the region of interest, followed by placing the ultrasound transducer with a medical ultrasound gel pad placed in front of it. At the marked position on the leg, four technical measurement readings are performed: 2x CortBS and 2x Multifocus, with repositioning the probe between individual measurements, the chronological order of which is not crucial. Scanning time for each measurement takes 1-2 minutes. Out of the four measurements, the two optimal measurements (one for CortBS and one for Multifocus) are selected by the device, based on pre-defined quality criteria.

BMD estimation in young and middle-aged men and women

DXA measurement of the hip and lumbar spine DEVICE

The following DXA measurements are to be performed: • Spine L1-4 • Hip left • Hip right (alternatively, if a valid measurement of the left hip is not possible) Scanning takes approximately 15 minutes. A maximum number of one repeat measurement is planned (e.g., hip or spine). Note: The DXA scan of the hip is performed on the same side of the body as the POROUS R4C ultrasound scan.

BMD estimation in young and middle-aged men and women

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female or male individuals aged 21 to and including 55 years.
• Written informed consent has been obtained.

You may not qualify if:

• Presence of diseases that rule out valid measurements with the DXA and POROUS R4C ultrasound devices (e.g., fractures or metal implants in the examined bones, paralysis of the lower extremities, severe bone abnormalities).
• Open wounds or skin infections at the measurement site of the POROUS R4C ultrasound device.
• Inability to undergo the investigations required by the Clinical Investigation Plan (CIP) or cognitive limitations that preclude understanding of the Participant Information Sheet and the Informed Consent Document.
• Pregnancy and breastfeeding
• Individual is in custody by order of an authority or a court of law.
• Close affiliation with an investigational site, e.g., employment at an investigational site, close relative of an investigator, or dependent person (e.g., student of the investigational site).

Sponsors & Collaborators

• POROUS GmbH: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (2)

Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

RECRUITING

Centre of Muscle and Bone Research (ZMK), Charité Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Related Publications (2)

• Dehnen C, Galindo A, Hoff P, Palme O, Maurer L, Raum K, Wiebe E. Quantitative ultrasound imaging reveals distinct fracture-associated differences in tibial intracortical pore morphology and viscoelastic properties in aged individuals with and without diabetes mellitus - an exploratory study. Front Endocrinol (Lausanne). 2024 Dec 16;15:1474546. doi: 10.3389/fendo.2024.1474546. eCollection 2024.

  PMID: 39736865 BACKGROUND

• Armbrecht G, Nguyen Minh H, Massmann J, Raum K. Pore-Size Distribution and Frequency-Dependent Attenuation in Human Cortical Tibia Bone Discriminate Fragility Fractures in Postmenopausal Women With Low Bone Mineral Density. JBMR Plus. 2021 Sep 2;5(11):e10536. doi: 10.1002/jbm4.10536. eCollection 2021 Nov.

  PMID: 34761144 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Fractures, Bone; Osteoporotic Fractures; Hip Fractures; Spinal Fractures

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Spinal Injuries; Back Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Gabriele Armbrecht, MD, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irina Lorenz-Meyer

CONTACT

+49 176 34448596; lorenz-meyer@porous.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, single-cohort, interventional study model: investigational device vs. comparator device.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 23, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)