Prolia (denosumab) / Amgen, GSK, BeiGene, Daiichi Sankyo - LARVOL DELTA

Combination therapy with HIF1α/c-MET peptide vaccine and bone-modifying agents is a promising strategy for suppressing bone metastases though a synergistic effect in mouse model of metastatic triple-negative breast cancer (AACR 2025) - "While bone-modifying agents such as denosumab (anti-RANKL) and bisphosphonate (zoledronic acid; ZA) have been commonly used to inhibit the activity of osteoclasts, they have limitations such as high cost and jaw osteonecrosis. To determine whether combination therapy can modulate the TME, tumor infiltrating lymphocytes (TILs) are being evaluated by assessing the expression of CD4 and CD8. Although further analysis of TME is necessary, we propose that the combination therapy of HIF1α/c-MET peptide vaccine with bone-modifying agents may provide a promising strategy for suppressing bone metastases in mTNBC."

Combination therapy • IO biomarker • Preclinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8 • HIF1A • MET • TRAP

A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers. (ANZCTR) - P1 | N=204 | Completed | Sponsor: CuraTeQ Biologics Private Ltd. | Recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

BTE-EN1, a novel acting heterobifunctional compound inhibiting bone destruction by established prostate cancer bone metastasis (AACR 2025) - "In a separate study, BTE-EN1 treatment prior to intra-cardiac injection of PCa cells led to dose-dependent significant prolongation of life, a finding not seen with bisphosphonate and denosumab therapies...Additional studies supporting translation to the clinic include non-interference with therapy used to treat advanced PCa, as well as inhibition of cell motility across a panel of human cancer cell types associated with bone destruction.In conclusion, BTE-EN1 is a first-in-class highly active heterobifunctional compound that inhibits bone destruction in established PCa bone metastasis and is well tolerated. Our data strongly suggests that BTE-EN1 has high potential for translation into humans and constitutes a novel therapeutic strategy."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Enhanced therapeutic effect of combining denosumab with PD-1 inhibitor in advanced KRAS-mutated lung adenocarcinoma (AACR 2025) - "Our study sheds light on the role of RANKL overexpression in promoting immunosuppression and ICI resistance in KRAS-mutated lung adenocarcinoma. Our results indicate that the combination of RANKL inhibitor and PD-1 inhibitor could be a promising therapeutic strategy for this patient subset."

IO biomarker • Metastases • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • CXCL10 • CXCL11 • CXCL9 • KRAS • PD-L1 • TNFSF11

Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients (clinicaltrials.gov) - P4 | N=70 | Recruiting | Sponsor: National Taiwan University Hospital

New P4 trial • Osteoporosis • Rheumatology

Malignant giant cell tumor of bone: A case series in the denosumab era. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Solid Tumor

Denosumab monotherapy versus bisphosphonate switching in breast cancer bone metastases: A real-world cohort study on skeletal events and safety. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Monotherapy • Real-world • Real-world evidence • Breast Cancer • Oncology • Solid Tumor

Evaluating diagnostic uncertainty and the role of surgical management in cherubism: a review of nine cases. (PubMed, Oral Surg Oral Med Oral Pathol Oral Radiol) - "Cherubism is a rare disease that requires an individualized management approach. Surgical management is effective in aggressive cases involving rapidly expanding lesions, impending pathologic fracture, and severe psychosocial distress. Denosumab is a promising adjuvant therapy for enhancing surgical outcomes."

Journal • CNS Disorders • Genetic Disorders • Musculoskeletal Diseases • Ophthalmology • Orthopedics • Rare Diseases

Treatment of myeloma bone disease: When, how often, and for how long? (PubMed, J Bone Oncol) - "New data have also emerged investigating the effect of the RANKL inhibitor denosumab compared to zoledronic acid (ZOL). Randomized trials have investigated longer treatment durations, which becomes more relevant as patients now live longer. In addition in this review, data regarding interval between individual treatment, impact of remission status, new data in relation to rebound after discontinuation and of denosumab, as well as the rational for drug holidays before dental procedures will also be discussed."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology • Orthopedics

Prostate Cancer With Orbital Metastasis. (PubMed, Cureus) - "The patient was diagnosed with high tumor burden and castration-naïve metastatic PCa and treated with a combination regimen of androgen deprivation therapy, docetaxel, and darolutamide, resulting in significant reduction in prostate-specific antigen levels. Surgical resection and palliative radiation were employed to manage the orbital mass, and ongoing treatment with denosumab was initiated to address the extensive bone metastases. This case highlights the clinical challenges and treatment considerations in patients with atypical metastatic spread of PCa and emphasizes the need for a multidisciplinary approach in managing such complex presentations."

Journal • Atrial Fibrillation • Cardiovascular • Eye Cancer • Genito-urinary Cancer • Hypertension • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Clinical efficacy of osteoporosis treatments (PubMed, Rev Med Suisse) - "Osteoporosis therapy includes antiresorptive drugs of varying efficacy (estrogens, raloxifene, bisphosphonates, denosumab) and osteoanabolic agents capable of stimulating bone formation through various mechanisms (teriparatide, abaloparatide, romosozumab). For all treatments, the risk of severe adverse events remains very low. However, the reversibility of the effects of most osteoporosis treatments, except for bisphosphonates, makes it essential to consolidate their effects with a bisphosphonate."

Journal • Musculoskeletal Diseases • Osteoporosis • Rheumatology

Sequential drug treatments for osteoporosis (PubMed, Rev Med Suisse) - "When denosumab is stopped, bisphosphonates reduce the rebound effect and limit the risk of vertebral fractures. Osteoanabolic treatments are used for 12 (romosozumab) to 24 months (teriparatide)...Regular monitoring is necessary to assess whether drug treatment should be interrupted, continued, or extended. The aim is to preserve bone health into old age and prevent fractures."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Reply to letter to the Editor regarding "Real world clinical outcomes when discontinuing denosumab or bisphosphonates in patients with surgically managed osteoporotic vertebral compression fractures: a population-based cohort study". (PubMed, Spine J) - No abstract available

Clinical data • Journal • Real-world evidence • Musculoskeletal Diseases • Orthopedics

Letter to the Editor regarding "Real world clinical outcomes when discontinuing denosumab or bisphosphonates in patients with surgically managed osteoporotic vertebral compression fractures: a population-based cohort study" by Huang et al. (PubMed, Spine J) - No abstract available

Clinical data • Journal • Real-world evidence • Musculoskeletal Diseases • Orthopedics

Monoclonal Antibodies and Small-Molecule Inhibitors Associated Osteonecrosis of Jaw: A Retrospective Pharmacovigilance Study. (PubMed, J Oral Maxillofac Surg) - "Denosumab, romosozumab, and lenvatinib are significantly associated with ONJ, particularly in older and female patients. Further research is needed to understand the mechanisms and improve risk management strategies."

Adverse events • Journal • Retrospective data

Updates on bone health in people living with HIV: global impact, prediction tools, and treatment. (PubMed, Curr Opin HIV AIDS) - "Despite advancements in ART, osteoporosis and fragility fractures remain common among PLWH. There is a need for continued research on development of fracture risk assessment tools including use of clinical data, imaging studies and biomarkers, and implementation of preventive and treatment strategies for at-risk subgroups."

Journal • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Evaluation of Sequential Romosozumab-Denosumab Therapy for Osteoporosis in Maintenance Hemodialysis Patients. (ERA 2025) - No abstract available

Clinical • Osteoporosis • Renal Disease • Rheumatology

Denosumab versus Bisphosphonates for Medication-Related Osteonecrosis of the Jaw and Recurrent Clinical Fractures among Japanese Patients on Haemodialysis: A Target Trial Emulation (ERA 2025) - No abstract available

Clinical • Musculoskeletal Diseases • Orthopedics

Potential Cardiovascular Benefits of Denosumab in Kidney Transplant Recipients: A Focus on Aortic Arch Calcification (ERA 2025) - No abstract available

Clinical • Cardiovascular • Transplantation

Effect of denosumab on bone mineral density and microarchitecture assessed by HRpQCT in dialysis patients: a longitudinal study (ERA 2025) - No abstract available

Clinical • Longitudinal study • Observational data • Chronic Kidney Disease • Nephrology • Renal Disease

Hypocalcemia and other bone and mineral disorders associated with denosumab across the spectrum of kidney function: the Stockholm CREAtinine Measurements (SCREAM) project (ERA 2025) - No abstract available

Endocrine Disorders

Navigating Stomatologic Complications Secondary to Antineoplastic Agents-A Comprehensive Review. (PubMed, Cancers (Basel)) - "In particular, bone-modifying agents such as bisphosphonates and denosumab disrupt bone remodeling and the formation of new blood vessels, thereby increasing the susceptibility to osteonecrosis of the jaw, especially following invasive dental procedures...Furthermore, it emphasizes the importance of pre-treatment dental evaluation and preventive strategies including patient education, prophylactic dental care, and the integration of adjunctive therapies such as laser therapy and autologous platelet concentrates to mitigate these adverse effects. The analysis advocates for interdisciplinary collaboration between oncologists and dental professionals to optimize management protocols, enhance treatment adherence, and ultimately improve the quality of life for oncology patients undergoing anti-cancer therapy."

Journal • Review • Dental Disorders • Infectious Disease • Mucositis • Oncology • Xerostomia • EGFR

A retrospective study on odontogenic and non-odontogenic medication-related osteonecrosis of the jaw: Potential differences in clinical features and treatment outcomes. (PubMed, J Dent Sci) - "Non-odontogenic MRONJ was slightly more common among patients with malignancies who received denosumab; however, the difference was not significant...Compared with that in odontogenic MRONJ, the treatment outcome in non-odontogenic MRONJ is poor. Further studies are required to clarify the true nature of non-odontogenic MRONJ."

Journal • Retrospective data • Dental Disorders • Infectious Disease • Oncology • Periodontitis

Long-Term Denosumab Treatment in Adults with Juvenile Paget Disease. (PubMed, Calcif Tissue Int) - "Vision remained unchanged in subject 2, but subject 1 experienced sudden vision loss of the right eye at age 46, which was successfully managed with intravitreal treatment with anti-vascular endothelial growth factor medications. In conclusion, long-term denosumab administration in adults with JPD, who had been previously treated with bisphosphonates, was safe and effective in terms of the skeletal disease, but it may not prevent the emergence of retinopathy."

Journal • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rare Diseases • Retinal Disorders • TNFRSF11B

Minimizing STOPP and Beers Criteria Risks in PIM Treatments Using PM-TOM and ChatGPT: A Case Study. (PubMed, Stud Health Technol Inform) - "She was initially prescribed acetaminophen, alendronate, omeprazole, lisinopril, metoprolol, aspirin, citalopram, and vitamin D, which were assessed as inadequate...In the optimized treatment, omeprazole (PPI) was replaced with famotidine (H2-blocker), citalopram (SSRI) with agomelatine (atypical antidepressant), zoledronic acid (bisphosphonate) with denosumab (RANK ligand inhibitor), aspirin (NSAID) with ticagrelor (antiplatelet), and lisinopril with benazepril (ACE inhibitor)...Finally, ChatGPT validated the proposed adjustments, confirming their alignment with the guidelines and highlighting the potential for longer-term benefits. This case study illustrates how a combined use of PM-TOM and AI tools can effectively support the clinical decision-making process by optimizing polypharmacy treatments and minimizing their PIMs, major contributors to morbidity in older adults and high healthcare costs."

Journal • Cardiovascular • CNS Disorders • Coronary Artery Disease • Depression • Gastroesophageal Reflux Disease • Heart Failure • Hypertension • Immunology • Osteoarthritis • Osteoporosis • Pain • Psychiatry • Rheumatology