Prolia (denosumab) / Amgen, BeOne Medicines, Daiichi Sankyo - LARVOL DELTA

Ixazomib combined with daratumumab-based regimens as first-line therapy for transplant-ineligible patients with newly diagnosed multiple myeloma: A real-world historical database analysis from China (ASH 2025) - P2 | "The DI-based regimens included DICd (C: cyclophosphamide; d: dexamethasone) plus vinorelbine (VDS), DId plus VDS, DId plus denosumab, DId plus venetoclax (VEN), DIPd (P: pomalidomide), DIR (R: lenalidomide), and DIRd plus VEN. Conclusion The DI-based regimen, as an initial treatment option for transplant-ineligible NDMM patients, demonstrates efficacy comparable to that observed in previous prospective randomized controlled trials (RCTs) (NCT03012880, NTR6297, ORR: 71–96%). This real-world study conducted in China further supports the promising efficacy and acceptable safety profile of the ixazomib plus daratumumab-based regimen as a first-line treatment for transplant-ineligible NDMM patients in routine clinical practice, including among elderly patients with multiple comorbidities."

Clinical • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Diabetes • Hematological Disorders • Hematological Malignancies • Hepatology • Hypertension • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease • Transplantation • Vascular Neurology

Simultaneous Reconstruction of Bimaxillary Stage 3 Medication-Related Osteonecrosis of the Jaw Using the Buccal Fat Pad Flap Combined With Submandibular Gland Flap. (PubMed, J Craniofac Surg) - "This study reports a case of a female patient with metastatic breast cancer who had received long-term denosumab therapy...No recurrence of MRONJ or progression of the primary malignancy was observed. These findings suggest that the combined use of the BFP flap and SMGF can effectively reconstruct bimaxillary stage 3 MRONJ defects with favorable outcomes."

Journal • Breast Cancer • Oncology • Otorhinolaryngology • Respiratory Diseases • Sinusitis • Solid Tumor

Final analysis of the evaluation of safety and efficacy of denosumab in patients with multiple myeloma and severe renal impairment: An IMWG bone subcommittee study (ASH 2025) - "Renal impairment (RI), a cardinal feature of MM, further complicates treatment strategies.Denosumab, a bone-directed agent, has demonstrated non-inferiority to zoledronic acid but its efficacyand safety in patients with severe RI remains underexplored. Denosumab 60 mg, monthly,seems to be sufficient to prevent both SREs and hypocalcemia. However, further prospective researchwith larger cohort and longer follow-up period will confirm these results and refine treatment guidelines."

Clinical • Chronic Kidney Disease • Endocrine Disorders • Hematological Malignancies • Metabolic Disorders • Multiple Myeloma • Musculoskeletal Diseases • Orthopedics • Renal Disease

Real-world utilization patterns of bone-modifying agents for multiple myeloma in the era of novel therapies (ASH 2025) - "Among those diagnosed between 2018 and 2023 and with BMA during thestudy period (n=422), the initial BMA was a bisphosphonate for 339 (80.3%) and denosumab for 83(19.7%)...Other variables were not significant predictors in themodel.ConclusionDelays and underuse of BMAs in patients with NDMM have not markedly improved in the era of noveltherapies. Future studies should examine the barriers to the timely initiation of BMAs."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma

Optimizing skeletal health: An analysis of bone-modifying agent prescription patterns and incidence of skeletal-related events in multiple myeloma (ASH 2025) - "Afterthe diagnosis of MM, 185 patients (85.6%) were prescribed BMA (75.1% zoledronate, 11.4% denosumaband 12.4% Pamidronate). Among patientswho received BMA, 17.8% developed SREs predominantly between two to five years after the first dose,which is comparable to previous studies. Future studies may look into initiatives to improve guidelineadherence."

Hematological Malignancies • Multiple Myeloma • Musculoskeletal Diseases

Treatment outcomes in patients with newly diagnosed multiple myeloma receiving ixazomib as initial therapy: A retrospective, observational, real-world historical database analysis from China (ASH 2025) - "About 65% of the patients had at least one comorbidity, withthe most common being hypertension (38%), renal disorders (35%), cardiovascular diseases (31%),diabetes (18%), and liver disorders (17%).Ixazomib-based regimens consisted of combinations such as Ixazomib plus IMiD with or without otheragents (e.g., IR[Ixazomib, lenalidomide], ITd[Ixazomib, thalidomide, dexamethasone], IPd[Ixazomib,pomalidomide, dexamethasone], IRAd[Ixazomib, lenalidomide, aclarubicin, dexamethasone],IRCd[Ixazomib, lenalidomide, cyclophosphamid, dexamethasone]) and Ixazomib plus dexamethasonewith or without additional agents (e.g., ICd[Ixazomib, cyclophosphamid, dexamethasone], IACd[Ixazomib,aclarubicin, cyclophosphamid, dexamethasone], Id + epirubicin, ICd + epirubicin , Id + denosumab,IMd[Ixazomib, melphalan, dexamethasone]). Survival outcomes remain under ongoing follow-up. Thesefindings suggest that ixazomib-based therapy may serve as a viable first-line treatment option, even forpatients..."

Real-world • Real-world evidence • Retrospective data • Cardiovascular • Diabetes • Hematological Malignancies • Hepatology • Hypertension • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease

BH22 Alopecia areata caused by an adverse reaction to denosumab. (PubMed, Br J Dermatol) - "Alopecia areata and other autoimmune reactions have been seen with other biologic drugs, including dupilumab (interleukin-14 and interleukin-3 inhibitor) and anti-tumour necrosis factor (TNF)-α medications. Based on the timeline, it was unlikely that simvastatin had triggered the process. This case is one of only a handful of reports of denosumab inducing alopecia areata and it is important to consider this as a cause in patients taking this medication."

Journal • Alopecia • Dermatology • Dyslipidemia • Immunology • Musculoskeletal Diseases • Oncology • Orthopedics • Osteoporosis • Rheumatology

Severe cutaneous adverse reactions to anti-osteoporosis drugs: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database and a review of published cases. (PubMed, Front Pharmacol) - "Denosumab (24%), alendronate (23.25%), and zoledronic acid (17.13%) were most frequently reported. Anti-osteoporosis drugs, notably bisphosphonates and strontium ranelate, are rarely linked to SCARs but may cause serious consequences. Increased clinical awareness, pre-treatment risk evaluation, and vigilant monitoring are essential for at-risk patients."

Adverse events • Journal • Real-world evidence • Dermatology • Osteoporosis • Rheumatology • Steven-Johnson Syndrome • Vasculitis

Excellent Results in the Off-Label Use of Denosumab in Pediatric Oncology: Monocentric Case Series Study. (PubMed, Case Rep Pediatr) - "This study confirms literature data about the use of denosumab in inoperable GCRTB. These results are preliminary; further studies are necessary on a larger series of cases, with a longer follow-up (3-5 years), with data collection even from other pediatric centers."

Journal • Endocrine Disorders • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Pediatrics • Solid Tumor • GCG

Individual and Community-level Determinants of Osteoporosis Treatment Following Fracture Among Medicare Beneficiaries. (PubMed, J Gen Intern Med) - "OP treatment after fracture remains suboptimal-especially among men-despite clear guidelines. Engagement with preventive care was strongly associated with treatment initiation. Community socioeconomic disadvantage and depression were also important barriers to post-fracture treatment, with sex-specific patterns. Integrating fracture-care pathways into preventive visits and focusing on socioeconomically disadvantaged communities could improve secondary fracture prevention."

Journal • Medicare • Reimbursement • US reimbursement • CNS Disorders • Depression • Infectious Disease • Influenza • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Pneumococcal Infections • Preventive care • Psychiatry • Respiratory Diseases • Rheumatology

Comparative Finite Element Analysis of Denosumab and Bazedoxifene on Pedicle Screw Stability in Osteoporotic Spines. (PubMed, JOR Spine) - "Finite element modeling suggested that Dmab enhanced pedicle screw fixation more effectively than BZA, particularly against axial and cranial/lateral-directed forces. These biomechanical differences underscore the potential advantage of Dmab in preoperative osteoporosis management to improve pedicle screw stability."

Journal • Osteoporosis • Rheumatology

Osteoporosis and Fracture Risk in Ovarian Cancer: Beyond the Oncologic Burden. (PubMed, Diagnostics (Basel)) - "Antiresorptive therapies, particularly bisphosphonates and denosumab, together with calcium, vitamin D, exercise, and fall-prevention strategies, have demonstrated efficacy in reducing fracture risk, although disease-specific guidelines are still lacking. Fracture prevention in ovarian cancer survivors is often overlooked despite its significant impact on morbidity and quality of life. Integrating bone health assessment and early antiresorptive therapy into care pathways is warranted, and future studies should develop tailored guidelines to make bone protection a key element of survivorship care."

Journal • Review • Gynecology • Musculoskeletal Diseases • Oncology • Orthopedics • Osteoporosis • Ovarian Cancer • Rheumatology • Solid Tumor

Renal function predicts 12-month response to romosozumab readministration after denosumab in women with osteoporosis. (PubMed, Arch Osteoporos) - "Lower baseline eGFR was an independent predictor of greater LS or TH BMD response to romosozumab readministration after denosumab, with an optimal cutoff value of 54 mL/min/1.73 m2. Larger studies are needed to validate these findings."

Clinical • Journal • Osteoporosis • Rheumatology

Romosozumab and Denosumab Combination Therapy After Denosumab in Postmenopausal Osteoporosis. (PubMed, Arthritis Rheumatol) - "Ongoing treatment with denosumab did not blunt the anabolic response of romosozumab, indicating sustained modeling-based bone formation activity. Adding romosozumab in patients failing denosumab might be a valuable option."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

How to optimize the use of anti-osteoporotic medication in clinical practice? (PubMed, Expert Opin Pharmacother) - "New data are available to guide the choice of start and sequence of anti-resorptives and osteo-anabolics according to the level of fracture risk in postmenopausal women, in patients treated with glucocorticoids, after a hip fracture and in patients treated with a treat to target strategy. Integrating FRAX, the level of aBMD, a detailed fracture history including imaging of the spine, and additional risk factors contributes to decide on treatment with antiresorptive-treatment (in high-risk subjects) and osteoanabolic-treatment (in very high-risk subjects) and their sequence to achieve a target with a low fracture risk which needs lifelong follow up for further diagnostic and treatment decisions."

Journal • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

The efficacy and safety of romosozumab sequential therapy in postmenopausal women: A systematic review and meta-analysis. (PubMed, J Orthop) - "Sequential treatment with romosozumab followed by anti-resorptive agents (e.g., denosumab, alendronate) significantly reduced fracture incidence and increased BMD at the lumbar spine, total hip, and femoral neck compared to non-sequential therapy. Romosozumab sequential therapy may reduce fracture risk and improve BMD in postmenopausal women with osteoporosis, without a significant increase in short-term adverse events. However, evidence regarding new vertebral fractures and certain BMD outcomes remains limited in robustness, warranting further validation through high-quality, long-term studies."

Journal • Retrospective data • Review • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Drugs against osteoporosis in perimenopausal and postmenopausal women. (PubMed, Front Med (Lausanne)) - "Commonly used anti-resorptive drugs include bisphosphonates, denosumab, hormone replacement therapy, and raloxifene...Common examples include teriparatide, romosozumab, and parathyroid hormone...Phytoestrogens. These are non-steroidal, naturally occurring plant compounds with estrogenic and/or anti-estrogenic properties that resemble estrogen."

Journal • Review • Osteoporosis • Rheumatology

DENMUSIN: The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Aarhus University Hospital

New P4 trial • Osteoporosis • Rheumatology

Refractory hypercalcemic crisis: A case of primary hyperparathyroidism with Gitelman syndrome. (PubMed, J Int Med Res) - "The patient experienced recurrent hypercalcemic crises that required treatment with zoledronic acid and denosumab after conventional interventions failed. This case emphasizes that hypocalciuria in the setting of persistent hypercalcemia-especially when severe hypomagnesemia is present-should raise suspicion for underlying Gitelman syndrome. Early identification of this coexistence is essential, as optimal management requires surgical treatment of primary hyperparathyroidism followed by targeted correction of electrolyte abnormalities associated with Gitelman syndrome, ultimately improving clinical outcomes."

Journal • Endocrine Disorders • Metabolic Disorders • Nephrology • Renal Disease

Potential role of the comprehensive tooth extraction procedure in preventing medication related osteonecrosis of the jaw (MRONJ): a prospective cohort study. (PubMed, Orphanet J Rare Dis) - "This prospective cohort study provides evidence that implementing an effective and rational treatment protocol during tooth extractions significantly benefits high-risk MRONJ patients. Adherence to such protocols minimizes the risk of postoperative infection, fosters improved healing of extraction sites, and maximizes the prevention of MRONJ."

Journal • Dental Disorders • Infectious Disease • Oncology • Osteoporosis • Periodontitis • Rheumatology

Systemic Conditions and Medication Use in Older Patients Undergoing Dental Implants: A Nationwide Cross-Sectional Study. (PubMed, Clin Implant Dent Relat Res) - "Most older patients who underwent implant surgery had systemic diseases, and approximately 10% were prescribed medications. Cerebrovascular and kidney diseases increased the risk of implant removal, whereas osteoporosis or antiresorptive therapy decreased the risk. With the increasing use of DOACs, IV bisphosphonates, and denosumab, clinicians carefully review the medical histories of older implant patients."

Journal • Observational data • Retrospective data • Cardiovascular • Diabetes • Hypertension • Immunology • Metabolic Disorders • Nephrology • Osteoporosis • Renal Disease • Rheumatology

Proton Pump Inhibitors Are Associated With Increased Risk of Site-Specific Nonunion After Open Reduction Internal Fixation. (PubMed, J Orthop Trauma) - "Proton pump inhibitor (PPI) use was associated with increased nonunion risk, particularly in tibia/fibula and radius/ulna fractures. Younger patients demonstrated greater susceptibility to PPI-associated nonunion. The findings indicated that PPI exposure may have adversely affected fracture healing in specific anatomical or demographic subgroups and warranted further investigation."

Journal • Cardiovascular • Chronic Kidney Disease • Genetic Disorders • Hypertension • Musculoskeletal Diseases • Nephrology • Obesity • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Clinical profiles and predictors of symptomatic skeletal events in patients with metastatic castration-resistant prostate cancer receiving denosumab. (PubMed, Int J Clin Oncol) - "In this real-world study, approximately 10% of patients with bone mCRPC developed SSEs during denosumab therapy, mostly within the first year. A prior SRE and high baseline bone tumor burden were significant predictors of skeletal complications, underscoring the importance of early risk stratification and timely initiation of bone-targeted therapies."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Musculoskeletal Diseases • Oncology • Osteosarcoma • Prostate Cancer • Solid Tumor

Pan-cancer bone metastasis atlas at single-cell resolution identifies a distinct tumor-associated macrophage subset for mediating Denosumab-induced immunosensitization in lung cancer bone metastasis. (PubMed, Int J Biol Sci) - "Denosumab facilitates the infiltration of CD8+ T cells into the interior of LC-BoM tissues. Based on this mechanism, we observed in both clinical cohorts and preclinical models that RANKL inhibitor can enhance the efficacy of immunotherapy in treating LC-BoM."

IO biomarker • Journal • Pan tumor • Breast Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • MMP9 • TNFRSF11A

Denosumab as a Potential Disease-Modifying Treatment in Indolent Systemic Mastocytosis-Related Osteoporosis. (PubMed, JCEM Case Rep) - "Over 3 years of treatment, the patient experienced a 7% increase in lumbar spine bone mineral density and a sustained decrease in serum tryptase levels to 12.0 to 14.3 ng/mL (SI: 12.0-14.3 μg/L), suggesting improved bone health and potential reduction in systemic mast cell burden. This case highlights the challenges in managing ISM-related osteoporosis and suggests a dual benefit of denosumab in improving bone mineral density and potentially reducing mast cell activity."

Journal • Gastrointestinal Disorder • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rare Diseases • Rheumatology