Advancing Bone Health Research: How IAG Helped Redefine Imaging-Based Assessment of Bone Integrity
Advancing Bone Health Research: How IAG Helped Redefine Imaging-Based Assessment of Bone Integrity
Accurately assessing bone healing and structural integrity remains one of the most persistent challenges in orthopedic and bone health research. While innovative therapies, from osteogenic implants to regenerative cell-based approaches, are rapidly advancing, imaging endpoints have struggled to keep pace. Traditional radiographic scoring systems are often narrow in scope, inconsistently applied, or insufficiently sensitive to capture meaningful changes in bone formation, union, and remodeling over time.
A newly published study now marks an important step forward. Through the development, standardization, and validation of a novel imaging-based scoring system, Image Analysis Group (IAG) has helped establish a more robust, reproducible approach to evaluating bone integrity and therapeutic impact in clinical trials, reinforcing its position as a leading imaging CRO and trusted scientific partner in bone health research.
The Need for Better Bone Imaging Endpoints
Bone healing is a dynamic, multidimensional process involving new bone formation, mechanical stability, and progressive remodeling. Yet many existing scoring systems focus on a single aspect of healing or are limited to specific fracture types. In trials evaluating advanced osteogenic therapies, this creates a critical gap: promising drug or device effects may go undetected simply because the tools used to measure them are inadequate.
Recognizing this unmet need, IAG collaborated with clinical and industry partners to design and deploy an extended, imaging-based scoring framework capable of capturing the full continuum of bone repair. The result is a refined system that builds on established methodology while addressing real-world limitations encountered in modern clinical trials.
Developing a New Standard for Bone Integrity Assessment
In the recently published study, IAG led the imaging strategy for a longitudinal trial evaluating bone healing in complex orthopedic indications, including congenital pseudoarthrosis and recurrent osseous non-union. Central to the study was the development of the extended Lane and Sandhu Scoring System (eLSS), a radiograph- and CT-based tool designed to better reflect contemporary therapeutic mechanisms and imaging realities.
Unlike traditional approaches, the eLSS explicitly differentiates between:
- Bone formation across the longitudinal defect,
- Bone union across the transverse plane, and
- Bone remodeling, assessed through the emergence of continuous cortical and trabecular architecture.
This nuanced framework allowed investigators to evaluate not just whether bone was healing, but how it was healing over time, an essential distinction when assessing advanced regenerative or cell-based therapies.
From Methodology to Trial Deployment
As an imaging CRO, IAG’s role extended well beyond scoring system design. The organization oversaw end-to-end imaging execution, including protocol alignment, longitudinal image handling, blinded expert reads, and adjudication workflows. Using IAG’s proprietary DYNAMIKA platform, expert musculoskeletal radiologists conducted independent reads across more than 200 radiographic and CT scans, ensuring consistency and traceability throughout the trial.
The results speak to the rigor of the approach. The novel scoring system demonstrated moderate to excellent interobserver agreement across imaging modalities, pathologies, and assessment types, validating its reliability in real-world clinical trial conditions. Importantly, this level of agreement was maintained even in anatomically complex scenarios, such as cross-union assessment, where conventional scoring systems often fall short.
Why This Matters for Sponsors and Developers
For sponsors developing therapies in bone health, orthopedic surgery, and regenerative medicine, this publication carries significant implications. Reliable, sensitive imaging endpoints are essential for:
- Demonstrating treatment efficacy in small or heterogeneous populations
- Supporting dose-response and mechanism-of-action analyses
- Strengthening regulatory submissions and peer-reviewed publications
By enabling standardized, reproducible assessment of bone integrity across time and modality, the new scoring framework helps reduce uncertainty and enhances confidence in trial outcomes.
IAG’s Role as a Strategic Imaging Partner
This bone health research publication reinforces Image Analysis Group’s position as more than a service provider. IAG operates at the intersection of imaging science, clinical trial operations, and therapeutic innovation, partnering with sponsors to solve complex endpoint challenges that directly impact development success.
With deep expertise in musculoskeletal imaging, quantitative analysis, and reader-based methodologies, IAG continues to support trials across orthopedics, rheumatology, and bone metabolism. Its ability to co-develop novel scoring systems, validate them scientifically, and operationalize them at scale sets IAG apart in an increasingly data-driven clinical research landscape.
Shaping the Future of Bone Health Trials
As the pipeline of bone-targeted therapies grows, so too does the need for imaging endpoints that reflect modern science. The newly published scoring system represents a meaningful advance toward that goal, and a model for how imaging CROs can actively shape the future of clinical research.
Through innovation, collaboration, and scientific rigor, Image Analysis Group is helping ensure that breakthroughs in bone health are not only developed, but accurately measured, understood, and brought to patients with confidence.
About Image Analysis Group (IAG)
Image Analysis Group (IAG) is a global imaging clinical research organization (iCRO) focused on de-risking and accelerating drug development through advanced imaging science and AI. IAG designs and runs imaging-centric clinical trials across oncology, immunology, neurology, rare diseases, musculoskeletal conditions, fertility and women’s health, partnering closely with biotech and pharma sponsors from early proof-of-concept through pivotal and real-world evidence studies.
Through its proprietary, cloud-native DYNAMIKA™ platform, IAG integrates centralized imaging workflows, blinded independent review, expert readers and AI-powered imaging biomarkers to deliver high-quality, regulator-ready imaging endpoints and decision-enabling insights that optimize trial design, reduce operational risk and unlock the full value of imaging data.
