Bindex® Clinical Evidence

Bindex® is supported by eight peer-reviewed clinical studies conducted across Finland, the USA, Germany, the Netherlands, and Austria. These studies validate its diagnostic accuracy, cost-effectiveness, and applicability across diverse patient populations and clinical settings.

The findings below highlight how Bindex® compares to DXA, supports early treatment decisions, and integrates into point-of-care workflows.

1. Lewiecki M. (2020)

Pulse-echo Ultrasound Identifies Caucasian and Hispanic Women at Risk for Osteoporosis
See abstract: PubMed

• Key Highlights
  • Objective: Evaluate whether pulse-echo ultrasonometry (PEUS) density index thresholds validated in Caucasian women also apply to Hispanic women.
  • Population: 293 postmenopausal women (153 Caucasian, 140 Hispanic).
  • Main Finding: Previously established DI thresholds achieved similar sensitivity (80%) and specificity (86–91%) across both ethnic groups, indicating no need for separate cutoffs for Hispanic women.

Clinical Relevance: Confirms Bindex® PEUS thresholds effectively identify women at risk of osteoporosis, regardless of being Caucasian or Hispanic.

2. van den Berg P. (2020)

The Use of Pulse-Echo Ultrasound in Women with a Recent Non-vertebral Fracture to Identify Those Without Osteoporosis and/or a Subclinical Vertebral Fracture: A Pilot Study
See abstract: PubMed

• Key Highlights
  • Objective: Determine how a portable pulse-echo ultrasonometry (P-UE) device can reduce unnecessary DXA/vertebral fracture assessment referrals in women with recent non-vertebral fractures.
  • Population: 209 women (aged 50–70) at a Fracture Liaison Service.
  • Main Finding: Depending on the chosen threshold, up to 19–37% of patients could avoid DXA/VFA without missing osteoporosis or subclinical vertebral fractures.

Clinical Relevance: P-UE can help fracture services quickly rule out high-risk patients who do not require further imaging, saving clinical time and resources.

3. Nazari-Farsani S. (2020)

Bone Mineral Density and Cortical-Bone Thickness of the Distal Radius Predict Femoral Stem Subsidence in Postmenopausal Women
See abstract: ScienceDirect

• Key Highlights
• Objective: Investigate whether ultrasound measurements of distal radius cortical thickness can predict femoral stem subsidence in hip arthroplasty.
  • Population: Postmenopausal women receiving cementless total hip arthroplasty.

Main Finding: Distal radius BMD and cortical-bone thickness predicted the risk of ≥2 mm stem subsidence (AUC ~0.73). Lower cortical thickness correlated with higher subsidence risk

4. Soini E. (2018)

Cost-effectiveness of Pulse-echo Ultrasonometry in Osteoporosis Management
See abstract: Dove Medical Press

• Key Highlights
• Objective: Evaluate the economic impact of adding pulse-echo ultrasound (PEUS) to osteoporosis diagnosis pathways in Europe.
  • Method: A 10-year cost–utility model comparing standard care vs. a pathway with PEUS.
  • Main Finding: Including PEUS saved €76–€121 per patient by reducing unnecessary DXA scans, while maintaining clinically appropriate treatment decisions.

Clinical Relevance: Strong economic rationale for large-scale integration of Bindex® PEUS in primary care and screening settings.

5. Karjalainen JP. (2018)

Pulse-echo Ultrasound Method for Detection of Post-Menopausal Women with Osteoporotic BMD
See abstract: PubMed

• Key Highlights
• Objective: Investigate the effectiveness of a multi-site ultrasound device for identifying hip BMD in the osteoporotic range.
  • Population: 1091 women (ages 50–80), comparing ultrasound-based density index (DI) to DXA at the hip.
  • Main Finding: Using predefined DI thresholds, ~30% required a DXA follow-up, with 93.7% sensitivity and 81.6% specificity in detecting osteoporosis.

Clinical Relevance: A combined US+DXA approach can significantly reduce the need for DXA while maintaining high diagnostic accuracy.

6. Schousboe JT. (2016)

Prediction of Hip Osteoporosis by DXA Using a Novel Pulse-echo Ultrasound Device, Osteoporosis International
See abstract: PubMed

• Key Highlights
• Objective: Evaluate whether pulse-echo ultrasonometry can serve as a screening test to reduce routine DXA scans in postmenopausal women.
  • Population: 555 postmenopausal women, measuring BMD by DXA and cortical thickness by ultrasound.
  • Main Finding: PEUS allowed 73–69% of women to avoid DXA with 80–82% sensitivity and 81% specificity for detecting hip osteoporosis.

Clinical Relevance: Shows the potential for Bindex® as a first-line screening to quickly identify those at risk without immediate DXA referrals.

7. Karjalainen JP. (2016, WCO-IOF-ESCEO)

Sensitivity and Specificity of Osteoporosis Diagnostics at Primary Healthcare with Bindex®
See abstract: DownloadPDF here

• Key Highlights
• Objective: Assess pooled sensitivity and specificity of Bindex® in diagnosing osteoporosis at the proximal femur.
  • Population: 1830 Caucasian females from three independent trials.
  • Main Finding: In 70–73% of cases, Bindex® alone offered a definitive diagnosis; in a lower T-score subgroup, 90–93% sensitivity and 87% specificity were reported.

Clinical Relevance: Reinforces the reliability of Bindex® as a point-of-care ultrasound tool for large-scale primary healthcare screening.

8. Karjalainen JP. (2015)

New Method for Point-of-care Osteoporosis Screening and Diagnostics, Osteoporosis International
See abstract: PubMed

• Key Highlights
• Objective: Introduce a new ultrasound method to address the underdiagnosis of osteoporosis in primary care settings.
  • Population: 572 Caucasian women (ages 20–91), with a subset undergoing DXA of the hip.
  • Main Finding: Combining Bindex® with FRAX could reduce the need for DXA by 16–28%, maintaining high sensitivity (≥85%) and specificity (≥78%).

Clinical Relevance: Early evidence that Bindex® can bridge the diagnostic gap, identifying more osteoporotic patients in primary care while minimizing DXA usage.