Prolia (denosumab)

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.

P=N/A, N=30, Recruiting, Wuhan Union Hospital, China | Completed --> Recruiting | Trial completion date: Mar 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Dec 2025

P=N/A, N=100, Recruiting, University of Colorado, Denver | Trial completion date: Mar 2026 --> Apr 2028 | Trial primary completion date: Mar 2025 --> Mar 2028

P1, N=80, Not yet recruiting, Shandong Provincial Hospital Affiliated to Shandong First Medical University; Shandong Provincial Hospital Affiliated to Shandong First Medical Univer

P4, N=84, Not yet recruiting, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital); The First Affiliated Hospital of Nanjing Medical University (

P4, N=36, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting

This case highlights the potential benefits of CDK4/6 inhibitors combined with endocrine therapy in the management of HR+, HER2-negative metastatic breast cancer, particularly in cases with skin involvement. These agents have reshaped the therapeutic landscape, providing prolonged disease control and improved patient outcomes.

Tartrate-resistant acid phosphatase-5b (TRACP-5b), a marker of bone resorption, was a biomarker for the required amount of calcium in this case. Patients with lung cancer with diffuse osteoblastic bone metastases could develop severe hypocalcemia and require long-term calcium supplementation.

Eight of 15 patients with available treatment history received denosumab before a diagnosis of malignancy...Most patients were treated with chemotherapy; 1 patient (PD-L1 TPS >95%) was treated with pembrolizumab, with complete clinical response of metastatic disease at 2.5 years. In conclusion, malignant giant cell tumors of bone typically arise from long bones, harbor osteosarcomatous and/or chondrosarcomatous differentiation, and show significant risk for distant metastasis and demise. Our data suggest that copy number analysis may be useful in distinguishing malignant giant cell tumors of bone from their conventional, atypical, and metastasizing conventional counterparts.

Quality of life exhibits a great improvement in the first 3 months, especially in the physical role, emotional functioning, fatigue, pain, dyspnoea, insomnia, appetite loss, constipation, and diarrhea, and then maintained with little variations. This case suggests that a highly structured physical exercise program may be feasible, safe, and effective in patients with lung cancer and bone metastases if performed under the supervision of trained experts.

Finally, the pan-cancer analysis supported a negative correlation between SPP1 and CD8A levels, with the CD8A:SPP1 ratio correlating with overall survival in 14 cancer types, which was superior to either CD8A or SPP1 alone. Our research provides clinical evidence that denosumab improves antitumour immunity by decreasing SPP1 expression and enhancing cytotoxic T cell activity, serving as a milestone in the development of innovative use of denosumab and offering potential benefits to patients with elevated levels of SPP1.

P3, N=278, Completed, Shanghai Biomabs Pharmaceutical Co., Ltd. | Recruiting --> Completed

The results of the present study will help us elucidate the cellular mechanisms of MRONJ. Although culture of OLAB with zoledronate and denosumab significantly altered the protein expression patterns, future research is needed to examine the effects of bone scaffolds, biofilms, and additional cell types mimicking in vivo conditions.

Cinacalcet and denosumab were initiated due to persistent, severe hypercalcemia, followed by wedge resection and palliative radiotherapy of pulmonary metastases. Subsequently, his PTH levels began increasing despite continuation of olaparib and, after 20 months, rose to his original PTH level prior to the initiation of therapy. This is a unique case of a patient with metastatic PC who had a BRCA1 VUS mutation, with initial partial reduction in PTH and calcium levels after PARP inhibitor treatment.

P2, N=31, Active, not recruiting, Columbia University | Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2025 --> Mar 2026

Under the diagnosis of left breast cancer with cT2N3cM1(OSS), Stage Ⅳ, Luminal B like, we started treatment with anastrozole, leuprorelin, abemaciclib and denosumab. It also has a longer intracerebral retention time than other CDK4/6 inhibitors. Combination therapy with abemaciclib may be a useful treatment option for HR-positive, HER2-negative breast cancer with brain metastases.

Postoperative oral tamoxifen therapy was not effective. Second regimen S-1 with denosumab was very effective...The purpose of treatments for MBC is to maintain favorable QOL, as well as to improve survival. S-1 could be a valuable agent for breast cancer treatments, since it showed clinical efficacy and mild toxicity, and be given orally.

P2, N=82, Completed, Centre Hospitalier Annecy Genevois | Active, not recruiting --> Completed

P2, N=8, Completed, Arbeitsgemeinschaft medikamentoese Tumortherapie | Active, not recruiting --> Completed

P1/2, N=152, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting

P3, N=278, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.

P2, N=15, Active, not recruiting, National Institute of Dental and Craniofacial Research (NIDCR) | Recruiting --> Active, not recruiting

P=N/A, N=38, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

P4, N=313, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

P2, N=83, Tianjin Cancer Hospital Airport Hospital; Tianjin Cancer Hospital Airport Hospital

P1, N=22, Recruiting, Shanghai pulmonary hospital; Shanghai pulmonary hospital

RANK signaling mediates progesterone-driven regulation of mammary gland development and favors breast cancer initiation by controlling mammary cell proliferation and stem cell fate. Moreover, loss of RANK signaling increases sensitivity of breast cancer cells to chemotherapy, targeted therapies such as HER2 and CDK4/6 inhibitors, and immunotherapy. Finally, we describe clinical trials of denosumab for breast cancer prevention, such as those ongoing in women with high risk of developing breast cancer, large phase III clinical trials where the impact of adjuvant denosumab on disease-free survival has been assessed, and window trials to evaluate the immunomodulatory effects of denosumab in breast cancer and other solid tumors.

P3, N=300, Active, not recruiting, Alliance for Clinical Trials in Oncology | Recruiting --> Active, not recruiting

Molecular diagnostics played a crucial role in confirming the diagnosis and demonstrating that the true mutation harbored by GCTB is H3.3 p.Gly35Trp and not the formerly described (H3.3 p.Gly34Trp). Denosumab therapy effectively controlled the tumor without major side effects, although long-term treatment duration and safety require further study.

P4, N=200, Not yet recruiting, University Hospital, Toulouse

P2, N=55, Completed, Massachusetts General Hospital | Recruiting --> Completed

Down-regulation of receptor activator of nuclear factor kappa-B ligand (RANKL) expression in LC-BoM-PDTOs after in vitro DMAb intervention was associated with earlier clinical ossification efficacy of DMAb on BoM (median time: 5 vs. 8 months, P = 0.049). Accordingly, BoM-PDTOs can be expected to be a preferred model for predicting treatment response of bone metastatic tumors, considering its high-efficient expansion and good biological consistency with parental bone tumor tissues.

P2, N=22, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P4, N=70, Recruiting, Aristotle University Of Thessaloniki | Trial completion date: Dec 2025 --> Sep 2026 | Trial primary completion date: Dec 2024 --> Sep 2025

P4, N=155, Active, not recruiting, Dong-A ST Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jul 2025

P4, N=45, Active, not recruiting, University of Alabama at Birmingham | Trial primary completion date: Dec 2024 --> Aug 2025

P4, N=60, Not yet recruiting, Marmara University

P4, N=50, Active, not recruiting, Massachusetts General Hospital | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025

Denosumab has potential role for giant cell tumour of bone, it makes a less morbid surgery technically feasible. However, recurrence needs to be probed in long term follow up studies.

P4, N=63, Recruiting, Tuen Mun Hospital | Not yet recruiting --> Recruiting

Surgery was not possible due to comorbidities, so fulvestrant(500 mg/month)+denosumab(120 mg/month)was started. Furthermore, as the tumor markers were elevated, abemaciclib(300 mg/day)was added, which resulted in a decrease in the tumor markers...During the course of treatment, the tumor markers rose again, so the dose was increased to 250 mg/day, which resulted in a decrease in the tumor markers and good tolerability. At present, 36 months after the start of treatment, long SD has continued, no adverse events of grade 3 or higher have been observed, and the drug has been well tolerated.

We excluded those with a history of fragility fracture, multiple myeloma, Cushing's disease, primary hyperparathyroidism, osteomalacia, untreated vitamin D deficiency, secondary osteoporosis, or other systemic rheumatic diseases, as well as use of oral steroids for 2 or more weeks in the 6 months prior or current use of hormone replacement therapy, current oral bisphosphonate, past or current intravenous bisphosphonate, teriparatide, or denosumab therapies...This study of 30 patients with AxSpA found that abnormalities in bone density and microarchitecture at weightbearing sites were associated with longer disease duration. Because of its small sample size, larger studies are needed to better characterize the pathogenic disease factors that govern skeletal damage in AxSpA.