Trial reportArthritis research & therapy2021
Study TPX-100-5: intra-articular TPX-100 significantly delays pathological bone shape change and stabilizes cartilage in moderate to severe bilateral knee OA.
Trial report in Arthritis research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01925261 (A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees), which is not on this map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
Who cites it
20 citing papers in PubMed, 32 citations in OpenAlex.
- Current State of Orthobiologics in Treatment of Knee Osteoarthritis-Future Directions.International journal of molecular sciences · 2026Review
- Clinical validation of fully automated (peri-)articular tissue analysis for assessing osteoarthritis progression: A narrative review.Osteoarthritis and cartilage open · 2026Review
- Questionnaire on willingness and preference for biological treatment of knee osteoarthritis: a single-center cross-sectional survey.Clinical rheumatology · 2025Article
- The changes in 3D bone morphology mediate the association between meniscal extrusion and radiographic progression of osteoarthritis: data from the Osteoarthritis Initiative.Quantitative imaging in medicine and surgery · 2025Article
- Advances and Challenges in the Pursuit of Disease-Modifying Osteoarthritis Drugs: A Review of 2010-2024 Clinical Trials.Biomedicines · 2025Review
- 3D bone shape from CT-scans provides an objective measure of osteoarthritis severity: Data from the IMI-APPROACH study.Osteoarthritis imaging · 2024Article
- A Review of Current Approaches to Pain Management in Knee Osteoarthritis with a Focus on Italian Clinical Landscape.Journal of clinical medicine · 2024Review
- A brief review of current treatment options for osteoarthritis including disease-modifying osteoarthritis drugs (DMOADs) and novel therapeutics.Annals of medicine and surgery (2012) · 2024Review
- Prognostic value of B-score for predicting joint replacement in the context of osteoarthritis phenotypes: Data from the osteoarthritis initiative.Osteoarthritis and cartilage open · 2024Article
- 3-dimensional bone shape and knee osteoarthritis: What have we learned?Osteoarthritis imaging · 2024Article
- Using 3D MRI Bone Shape to Predict Pre-Osteoarthritis of the Knee 2 Years After Anterior Cruciate Ligament Reconstruction.The American journal of sports medicine · 2023Article
- Failure of cartilage regeneration: emerging hypotheses and related therapeutic strategies.Nature reviews. Rheumatology · 2023Review
- Review
- Targeting strategies for bone diseases: signaling pathways and clinical studies.Signal transduction and targeted therapy · 2023Review
- Recent Advances in Small Molecule Inhibitors for the Treatment of Osteoarthritis.Journal of clinical medicine · 2023Review
- Comparison of 3D quantitative osteoarthritis imaging biomarkers from paired CT and MR images: data from the IMI-APPROACH study.BMC musculoskeletal disorders · 2023Article
- An update on the effect of intra-articular intervention strategies using nanomaterials in osteoarthritis: Possible clinical application.Frontiers in bioengineering and biotechnology · 2023Review
- Latest insights in disease-modifying osteoarthritis drugs development.Therapeutic advances in musculoskeletal disease · 2023Review
- The current state of the osteoarthritis drug development pipeline: a comprehensive narrative review of the present challenges and future opportunities.Therapeutic advances in musculoskeletal disease · 2022Review
- Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs).Therapeutic advances in musculoskeletal disease · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy. This retrospective study compared MRI 3D femoral bone shape changes (B-scores) after intra-articular TPX-100 or placebo and analyzed the relationship between cartilage thickness and bone shape change over 12 months.
methodsOne hundred and four participants with bilateral moderate to severe knee cartilage defects were randomized to receive TPX-100 (200 mg) or placebo. Each subject's contralateral placebo-treated knee served as a paired internal control. After MRI quality control, 78/93 subjects (84%; 156 knees) were analyzed for quantitative femoral B-score and cartilage thickness. All analyses were performed centrally, blind to treatment assignment and clinical data.
resultsTPX-100-treated knees (n = 78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated knees at 6 and 12 months: 0.0298 (95% C.I. - 0.037, 0.097) vs 0.1246 (95% C.I. 0.067, 0.182) (P = 0.02), and 0.0856 (95% C.I. 0.013, 0.158) vs. 0.1969 (95% C.I. 0.123, 0.271) (P = 0.01), respectively. The correlation between bone shape change and medial and total tibiofemoral cartilage thickness changes at 12 months was statistically significant in TPX-100-treated knees (P < 0.01).
conclusionsThis is the first report of a potential therapy demonstrating a significant effect on bone shape measured by B-score in knee OA. These data, in combination with previously reported statistically significant and clinically meaningful improvements in WOMAC physical function versus placebo, support TPX-100 as a candidate for disease modification in knee OA.
trial registrationNIH ClinicalTrials.gov, NCT01925261 . Registered 15 August 2013.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.