ArticleInternational journal of cancer2021
Bone fracture as a novel immune-related adverse event with immune checkpoint inhibitors: Case series and large-scale pharmacovigilance analysis.
Article in International journal of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
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Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Bone health in patients with cancer: a SEOM-SEIOMM consensus review of risk factors, assessment strategies, and management approaches.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Japanese cancer survivors have a higher risk of fragility fractures over ten years.Scientific reports · 2026Article
- Immune Checkpoint Inhibitors and Bone Health: Mechanisms, Clinical Implications, and Emerging Perspectives on Bone Fragility.Current osteoporosis reports · 2026Review
- Bone Adverse Events in Cancer Patients Undergoing Immune Checkpoint Inhibitor Therapy: A Comprehensive Review of the Literature from the Clinical Action Group of the European Calcified Tissue Society.Calcified tissue international · 2026Review
- Deep learning-driven incidental detection of vertebral fractures in cancer patients: advancing diagnostic precision and clinical management.La Radiologia medica · 2025Article
- Bone mineral density changes following immune checkpoint inhibitor therapy: insights from a case series analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025Article
- Review
- Programmed cell death protein 1 (PD-1) blockade regulates skeletal remodeling in a sex- and age-dependent manner.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Article
- Changes in scanographic bone mineral density in melanoma patients treated with immunotherapy: a new irAE from real-life data.Scientific reports · 2025Article
- Assessing the effects of immune checkpoint inhibitors on bone utilizing machine learning-assisted opportunistic quantitative computed tomography.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2025Article
- Fractures Associated with Immune Checkpoint Inhibitors: A Disproportionality Analysis of the World Health Organization Pharmacovigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database.Scientific reports · 2025Article
- Incidence of fractures in patients with solid cancers treated with immune checkpoint inhibitors: a systematic review and meta-analysis of randomised controlled trials.BMJ oncology · 2025Article
- The regulatory effects of PD-1/PD-L1 inhibitors on bone metabolism: opportunities and challenges in osteoporosis management.Frontiers in immunology · 2025Review
- Progression of vertebral fractures in metastatic melanoma and non-small cell lung cancer patients given immune checkpoint inhibitors.Journal of bone oncology · 2024Article
- Treating Multilevel Cervical Degenerative Disk Disease in a Patient With Stage IV Lung Cancer With Notable Comorbidities Using a Drug Eluting Biomaterial: A Case Report.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2024Article
- Cancer treatment-induced bone loss.The Korean journal of internal medicine · 2024Review
- Immune-related osteoblastic bone alterations mimicking bone metastasis in a small-cell lung cancer patient treated with durvalumab: a case report.Translational lung cancer research · 2024Article
- Osteoporotic fractures: an unrecognized adverse event of immune checkpoint inhibitors?Journal for immunotherapy of cancer · 2024Review
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although immune checkpoint inhibitors (ICIs) are associated with different immune-related adverse events (irAEs), the potential effect on the skeleton is poorly defined albeit biologically plausible and assessable through pharmacovigilance. We described a case series of patients experiencing skeletal fractures while on ICIs at the National Cancer Institute of Milan. To better characterize the clinical features of skeletal irAEs reported with ICIs, we queried the FDA Adverse Event Reporting System (FAERS) and performed disproportionality analysis by means of reporting odds ratios (RORs), deemed significant by a lower limit of the 95% confidence interval (LL95% CI) > 1. Bone AEs emerging as significant were scrutinized in terms of demographic and clinical data, including concomitant irAEs or drugs affecting bone resorption or causing bone damage. Four patients with skeletal events while on ICIs were included in our case series, of which three exhibited vertebral fractures. In FAERS, 650 patients with bone and joint injuries and treated with ICIs were retrieved, accounting for 822 drug-event pairs. Statistically significant ROR was found for eight, two and one bone AEs respectively with PD-1, PD-L1 and CTLA-4 inhibitors, being pathological fracture (N = 46; ROR = 3.17; LL95%CI = 2.37), spinal compression fracture (42; 2.51; 1.91), and femoral neck fracture (26; 2.38; 1.62) the most common. Concomitant irAEs or drugs affecting bone metabolism were poorly reported. The increased reporting of serious vertebral fractures in patients without concomitant irAEs and no apparent preexisting risk factors could suggest a possible cause-effect relationship and calls for close clinical monitoring and implementation of dedicated guidelines.
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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 OpenQuestion graph.