Osteoarthritis

Biomarkers in osteoarthritis

Osteoarthritis is characterized by progressive joint degradation and abnormal remodeling of cartilage and bone tissue. The Nordic ProteinFingerPrint Technology™ provides extracellular matrix (ECM) biomarkers specifically designed to quantify the synthesis and degradation of critical joint components such as collagen and proteoglycans in osteoarthritic joints.

These biomarkers facilitate early patient stratification, enabling the identification and selection of individuals likely to experience rapid disease progression for inclusion in clinical trials. The primary endpoints in osteoarthritis clinical trials often involve demonstrating structural changes and slowing the deterioration of joint function and cartilage integrity as measured by imaging methods or patient-reported outcomes.

Publications

Why should you measure Nordic ProteinFingerPrint Technology™ biomarkers in osteoarthritis

Nordic Bioscience’s ECM biomarkers have the potential to detect treatment effects more rapidly and precisely than conventional imaging techniques or clinical assessments alone, thereby enabling shorter, more efficient, and cost-effective clinical trials.

Furthermore, these biomarkers are instrumental in precision medicine by continuously monitoring therapeutic responses, allowing clinicians to tailor treatments specifically to individual patient profiles. Importantly, these biomarkers are translational and can be effectively utilized in preclinical models, bridging early-stage research with clinical applications and supporting the comprehensive evaluation of novel therapies throughout the osteoarthritis drug development continuum.

Browse our rheumatology biomarkers

NordicPRO-C2™ identifies individuals with faster radiographic progression

Structural progression in knee OA is highly heterogeneous; only a fraction of patients lose enough cartilage within 1-2 years to show a treatment effect. Enriching trials with true “structural progressors” therefore boosts statistical power and lowers sample-size requirements for disease-modifying OA drug (DMOAD) programs.

NordicPRO-C2™—a type II collagen-formation biomarker— is associated with faster radiographic progression. In two cohorts (NYC and SMC), participants with low NordicPRO-C2™ lost more medial joint space in 24 months compared to those with high NordicPRO-C2tm. The odds of radiographic progression were >3-fold higher in the lowest quartile.

Consistent findings were seen in the FORWARD phase-II trial: placebo-treated knees with low NordicPRO-C2™ lost five-times more cartilage thickness than high NordicPRO-C2™ knees (-0.10 mm vs -0.02 mm) over 24 months. Importantly, the same low-NordicPRO-C2™ subgroup showed the greatest anabolic response to FGF-18 (sprifermin), underlining its predictive as well as prognostic value.

Using NordicPRO-C2™ to pre-select subjects aligns trial populations with both disease trajectory and expected mechanism of action, accelerating proof-of-concept.

Figure 1. NordicPRO-C2tm identifies a faster progression OA population

Pharmacodynamic biomarkers in osteoarthritis

In osteoarthritis drug development, pharmacodynamic (PD) markers are essential for demonstrating target engagement and guiding dose selection.

NordicARG™ is a neo‐epitope generated by ADAMTS-5–mediated cleavage of aggrecan and directly reflects cartilage matrix turnover. Serum levels of NordicARG™ provide a quantifiable readout of aggrecanase activity in both healthy volunteers and patients with OA.

The observed PK/PD relationship between M6495 exposure and ARG inhibition show how biomarkers help confirm target engagement and facilitate modeling to predict optimal dosing strategies. The high remodeling rate of aggrecan makes this marker also suitable for systemic profiling of intra-articular interventions.

Figure 2. NordicARG™ is sensitive to therapeutic intervention in healthy volunteers and individuals with osteoarthritis

Increase likelihood of successful drug trial outcomes with molecular endotyping

To maximize the likelihood of successful clinical trial outcomes, osteoarthritis (OA) drug trials need to target the right OA subpopulations, or endotypes. Tissue turnover biomarkers can reliably identify knee OA endotypes across different OA populations, and these endotypes remain stable within the length of a clinical trial.

We have developed an endotype predictive tool based on a panel of six blood-based biomarkers that enables:

  • Predictive enrichment of endotype subgroups biologically matched to drug mode-of-action.
  • Risk mitigation for clinical trial recruitment.

By enriching for the right subgroups in OA drug trials, it may lead to:

  • Larger effect size.
  • Smaller study population needed.
  • Identification of subgroups responsive to treatment.

Figure 3. Molecular biomarker based endotyping in APPROACH

OstaTrace™: Biomarker-based endotyping of osteoarthritis

By measuring a panel of six tissue turnover biomarkers in serum, we can determine endotypes on a patient-to-patient level and match the right patients with the right treatments.

  1. Bone degradation (sCTX-I): Elevated in OA and recommended marker of bone resorption
  2. Bone formation (N-MID): Predictive of BMD response to osteoporosis treatment
  3. Cartilage degradation (C2M): Elevated in mild and severe OA compared to no OA
  4. Cartilage formation (nordicPRO-C2™): Low levels indicate low cartilage repair endotype
  5. Connective tissue inflammation (C3M): Elevated in inflammatory OA subgroups
  6. Inflammation (PRO-C4): Associated with WOMAC pain in chronic inflammatory OA
Order OsteaTrade™ now

The Nordic ProteinFingerPrint Technology™ in rheumatic disorders

Unsure about how our technology can benefit your clinical trial in rheumatic disorder? Watch this short video and get an understanding of the benefit you gain from our biomarkers .

About Osteoarthritis

  • Osteoarthritis (OA) is the most common form of arthritis, characterized by the degeneration and breakdown of cartilage in the joints. OA primarily affects weight-bearing joints such as the knees, hips, and spine, though it can also occur in smaller joints like fingers and toes. It is typically a progressive disease, causing symptoms such as joint pain, stiffness, swelling, and reduced mobility.

  • Osteoarthritis affects millions of individuals globally and its prevalence increases with age. In the United States, approximately 32.5 million adults suffer from OA, making it one of the leading causes of disability in older adults. The risk of developing OA significantly rises after the age of 50, though it can also affect younger individuals, particularly due to joint injuries or obesity.

  • There is currently no cure for osteoarthritis; treatment primarily focuses on relieving symptoms and improving joint function. Common interventions include lifestyle changes such as weight management and regular exercise, physical therapy, pain-relieving medications, and supportive devices like braces or orthotics. In severe cases, surgical options such as joint replacement (arthroplasty) may be considered.

     

    Diagnosis of osteoarthritis typically involves a combination of clinical evaluation and imaging tests. Doctors assess joint pain, stiffness, and functional limitations during physical examinations. Imaging techniques, such as X-rays and MRI scans, are utilized to visualize the extent of cartilage loss, bone changes, and joint damage characteristic of osteoarthritis.

  • Extracellular matrix (ECM) biomarkers quantify cartilage and bone tissue turnover, offering insights into disease activity and progression. They are valuable in identifying fast progressors, monitoring treatment response, and supporting precision medicine strategies in clinical trials.

  • Yes, biomarkers like NordicPRO-C2™ and NordicARG™ help identify patients most likely to respond to treatment, track pharmacodynamic effects, and reduce sample sizes by targeting specific endotypes, ultimately increasing trial efficiency.

  • OstaTrace™ is a biomarker panel that classifies osteoarthritis patients based on biological signatures, such as cartilage degradation or inflammation. This endotyping approach helps match patients with therapies that target their specific disease mechanisms.

Get in touch

Are you interested in exploring collaboration possibilities?
Enter your information in the form and a representative will contact you shortly.
+45 4452 5252 Contact us via email!

    Nordic Bioscience’s assays and services are research use only products and services and do not qualify for medical or diagnostic purposes.

    Upcoming events

    No upcoming events

    News, events, and other resources

    Discover Nordic Bioscience