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Imaging atlas for eligibility and on-study safety of potential shoulder adverse events in anti-NGF studies (Part 3)
F W Roemer1, C W Hayes2, C G Miller3
1Quantitative Imaging Center (QIC), Department of Radiology, Boston University School of Medicine, Boston, MA, USA; Department of Radiology, University of Erlangen-Nuremberg, Erlangen, Germany.
Abstract:
Despite promising results, the U.S. Food and Drug Administration (FDA) put on hold trials assessing anti-nerve growth factor (a-NGF) compounds due to concerns over accelerated rates of OA progression. The mechanism of these events is unclear but joint adverse events were observed particularly in patients using a-NGFs in combination with non-steroidal anti-inflammatory drugs (NSAIDs), suggesting that the significantly greater analgesic effect of these separate classes of drugs prompted patients to permit increased joint load without experiencing the usual pain that would limit joint stress. Development of a-NGF drugs is continuing with stringent safety criteria included in future trials as a-NGF therapies offer potential as the first new class of analgesics in many years. Potential imaging joint safety findings and exclusionary criteria for eligibility for the large weight bearing joints were presented in parts I and II of this atlas. The shoulder as a non-weight bearing joint is likely to be less affected by increased loading due to efficacious pain reduction. However, it remains prone to degeneration especially due to concomitant rotator cuff pathology and previous trauma and inflammatory disorders. This third part of the atlas illustrates imaging findings relevant for eligibility and potential joint safety findings such as osteonecrosis, incidental findings such as large cystic lesions, inflammatory disorders, bone marrow disorders and metastases.
Insights
Anti-nerve growth factor (a-NGF) therapies show promise for pain relief but faced FDA holds due to concerns about osteoarthritis progression. Future trials will include strict safety criteria for these novel analgesics.
Area of Science:
- Orthopedics
- Pharmacology
- Radiology
Background:
- Anti-nerve growth factor (a-NGF) compounds, a potential new class of analgesics, faced clinical trial holds by the FDA.
- Concerns arose regarding accelerated osteoarthritis (OA) progression, particularly when a-NGFs were co-administered with non-steroidal anti-inflammatory drugs (NSAIDs).
Purpose of the Study:
- To present imaging findings relevant to patient eligibility and joint safety for a-NGF therapies.
- To discuss potential safety concerns, including osteonecrosis and other pathologies, in non-weight-bearing joints like the shoulder.
Main Methods:
- Review of imaging findings related to joint safety and eligibility criteria.
- Analysis of potential adverse events associated with a-NGF and NSAID co-administration.
- Focus on imaging characteristics of the shoulder joint, considering its non-weight-bearing nature.
Main Results:
- The combination of a-NGFs and NSAIDs may lead to increased joint loading due to enhanced analgesia, potentially exacerbating OA.
- The shoulder, while non-weight-bearing, is susceptible to degeneration from rotator cuff pathology, trauma, and inflammatory conditions.
- Imaging can identify safety concerns like osteonecrosis, cystic lesions, inflammatory disorders, bone marrow disorders, and metastases.
Conclusions:
- Continued development of a-NGF therapies requires stringent safety evaluations and imaging criteria.
- Understanding imaging findings is crucial for assessing eligibility and monitoring joint safety, especially in non-weight-bearing joints like the shoulder.
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