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    DRUG:

    Prolia (denosumab)

    i
    Other names: AMG 162, AMG162, AMG-162
    Company:
    Amgen, BeiGene, Daiichi Sankyo, GSK
    Drug class:
    RANK ligand inhibitor
    Related drugs:
    15h
    Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation (clinicaltrials.gov)
    P=N/A, N=20, Active, not recruiting, University of Calgary | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Prolia (denosumab) • zoledronic acid
    11d
    PORCUPINE: A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) (clinicaltrials.gov)
    P2, N=25, Completed, Redx Pharma Plc | Recruiting --> Completed | N=50 --> 25 | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Aug 2023 --> Apr 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    RNF43 (Ring Finger Protein 43) • RSPO2 (R-Spondin 2)
    |
    Opdivo (nivolumab) • Prolia (denosumab) • zamaporvint (RXC004)
    18d
    Comparative Efficacy, Safety, PK, and Immunogenicity Study (clinicaltrials.gov)
    P3, N=392, Active, not recruiting, Luye Pharma Group Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Prolia (denosumab) • Boyoubei (denosumab biosimilar)
    19d
    SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy (clinicaltrials.gov)
    P3, N=595, Terminated, ETOP IBCSG Partners Foundation | Completed --> Terminated; Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available
    Trial termination • Metastases
    |
    cisplatin • carboplatin • Prolia (denosumab)
    21d
    Denosumab Sequential Therapy (clinicaltrials.gov)
    P4, N=101, Completed, National Taiwan University Hospital | Recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    Prolia (denosumab) • zoledronic acid
    27d
    Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis (clinicaltrials.gov)
    P1/2, N=138, Not yet recruiting, Washington University School of Medicine
    New P1/2 trial • Combination therapy
    |
    capecitabine • Prolia (denosumab) • zoledronic acid • zunsemetinib (ATI-450)
    27d
    Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS (clinicaltrials.gov)
    P1, N=190, Completed, Biocon Biologics UK Ltd | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Oct 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    Prolia (denosumab)
    1m
    A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma (ACTRN12617000772347)
    P1/2, N=72, Completed, Peter MacCallum Cancer Centre | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Prolia (denosumab)
    1m
    Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers (clinicaltrials.gov)
    P1, N=132, Recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd
    New P1 trial
    |
    Prolia (denosumab)
    1m
    Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, VA Office of Research and Development | Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Mar 2027 | Trial primary completion date: Feb 2024 --> Feb 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Prolia (denosumab)
    1m
    AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov)
    P1, N=209, Completed, Alvotech Swiss AG | Active, not recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab)
    1m
    Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers (clinicaltrials.gov)
    P1, N=0, Withdrawn, Taizhou Mabtech Pharmaceutical Co.,Ltd | N=252 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Prolia (denosumab)
    1m
    Assessing EGFR-mutated NSCLC with bone metastasis: Clinical features and optimal treatment strategy. (PubMed, Cancer Med)
    The presence of BoM is a negative prognostic factor for NSCLC patients with an EGFR mutation, possibly due to the presence of extrathoracic metastases. However, adding AAT and denosumab, along with sequential osimertinib, to the treatment regimen for patients with BoM can improve survival outcomes.
    Retrospective data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Tagrisso (osimertinib) • Prolia (denosumab)
    2ms
    Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . (clinicaltrials.gov)
    P3, N=278, Recruiting, Shanghai Biomabs Pharmaceutical Co., Ltd. | Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    Prolia (denosumab)
    2ms
    Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China (clinicaltrials.gov)
    P4, N=100, Not yet recruiting, Amgen
    New P4 trial
    |
    Prolia (denosumab)
    2ms
    REDUSE: Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (clinicaltrials.gov)
    P3, N=1380, Active, not recruiting, Swiss Group for Clinical Cancer Research | Recruiting --> Active, not recruiting
    Enrollment closed • Head-to-Head
    |
    Prolia (denosumab)
    2ms
    Response of Bony Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers With Actionable Driver Mutations. (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, University of Colorado, Denver | Trial completion date: Mar 2024 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Prolia (denosumab) • zoledronic acid
    2ms
    Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects (clinicaltrials.gov)
    P1, N=252, Completed, Shanghai Henlius Biotech | Recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab)
    2ms
    Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease (clinicaltrials.gov)
    P3, N=478, Not yet recruiting, RenJi Hospital
    New P3 trial • Head-to-Head
    |
    Prolia (denosumab)
    2ms
    The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury (clinicaltrials.gov)
    P4, N=5, Terminated, James J. Peters Veterans Affairs Medical Center | N=32 --> 5 | Recruiting --> Terminated; Study ended early due to COVID-19
    Enrollment change • Trial termination
    |
    Prolia (denosumab)
    2ms
    Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® (clinicaltrials.gov)
    P1, N=225, Not yet recruiting, Xentria, Inc.
    New P1 trial
    |
    Prolia (denosumab)
    2ms
    The RANKL inhibitor denosumab in combination with dual checkpoint inhibition is associated with increased CXCL-13 serum concentrations. (PubMed, Eur J Cancer)
    Denosumab in combination with dual ICI modulates cytokine expression and T-cell composition in peripheral blood. The upregulation of CXCL-13, a key factor for initiating tertiary lymphoid structures, strengthens the hypothesis that denosumab indeed boost immunological effects.
    Journal • Combination therapy • Checkpoint inhibition • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • VEGFC (Vascular Endothelial Growth Factor C)
    |
    Prolia (denosumab)
    2ms
    Cost-Effectiveness Analysis of Denosumab in the Prevention of Skeletal-Related Events Among Patients With Breast Cancer With Bone Metastasis in India. (PubMed, JCO Glob Oncol)
    ZA once every 12 weeks is the cost-effective treatment option for BC with bone metastases in India. The present study findings hold significance for standard treatment guidelines under India's government-funded health insurance program.
    Journal • HEOR • Cost-effectiveness • Cost effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Prolia (denosumab) • zoledronic acid
    2ms
    Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI (clinicaltrials.gov)
    P4, N=40, Active, not recruiting, James J. Peters Veterans Affairs Medical Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Prolia (denosumab)
    3ms
    Squamous cell carcinoma of mandibular gingiva producing both parathyroid hormone-related protein and granulocyte colony-stimulating factor: a case report. (PubMed, Oral Maxillofac Surg)
    Based on these clinical and pathological findings, the patient was diagnosed with hypercalcaemia and leukocytosis associated with malignancy and was treated with denosumab...Therefore, chemotherapy was discontinued. One week after the chemotherapy was discontinued, the patient died of respiratory failure.
    Journal
    |
    PTHLH (Parathyroid Hormone Like Hormone)
    |
    Prolia (denosumab)
    3ms
    Could MRONJ Be Related to Osimertinib Monotherapy in Lung Cancer Patients after Denosumab Suspension? (PubMed, Healthcare (Basel))
    The patient suspended Denosumab for more than six months before teeth extraction for MRONJ prevention; hence, failure to discontinue Osimertinib led us to consider it a possible etiological factor. From a literature analysis, only one case has already been published reporting a possible Osimertinib-related occurrence of MRONJ in lung cancer patients. Our case is a further report that could be intended as an alert both for oncologists and dentists to share decisions about the oral management of such patients together, also informing them about this possible risk. Also, this report could trigger in the scientific community the necessity to evaluate further guidelines for similar doubtful cases in which the drug interaction, the mono-suspension, and the possible removable prosthesis-related additional trauma should be considered causes or con-causes.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tagrisso (osimertinib) • Prolia (denosumab)
    3ms
    Immunohistochemical expression of H3.3 G34W in 100 giant cell tumors of bone and its diagnostic mimics, including its value in resolving uncommon diagnostic scenarios: A single institutional study at a tertiary cancer referral center, India. (PubMed, Indian J Pathol Microbiol)
    The diagnostic sensitivity and specificity of H3.3 G34W for GCTB were 88.1% and 100%, respectively. This constitutes one of the first reports from our country, further validating the diagnostic value of H3.3 G34W in differentiating GCTB, including metastatic and malignant forms from its mimics, including small biopsy samples. Its value in various diagnostic dilemmas is presented and utility in identifying residual tumor cells in post-denosumab treated GCTBs is worth exploring.
    Journal
    |
    H3-3A (H3.3 Histone A)
    |
    Prolia (denosumab)
    3ms
    Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients (clinicaltrials.gov)
    P4, N=340, Not yet recruiting, Yonsei University
    New P4 trial
    |
    Prolia (denosumab)
    3ms
    Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis. (clinicaltrials.gov)
    P4, N=100, Recruiting, Xi'an Honghui Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Prolia (denosumab)
    3ms
    A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov)
    P3, N=479, Completed, Celltrion | Active, not recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab)
    3ms
    Denosumab for Smoldering Multiple Myeloma (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, University of Rochester | Trial completion date: Jun 2024 --> Jun 2025
    Trial completion date
    |
    Prolia (denosumab)
    3ms
    Bisphosphonates for Prevention of Post-Denosumab Bone Loss (clinicaltrials.gov)
    P2, N=27, Completed, Columbia University | Active, not recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab) • zoledronic acid
    4ms
    Immune modulation with RANKL blockade through denosumab treatment in patients with cancer. (PubMed, Cancer Immunol Res)
    We also saw broad induction of CTLA-4 and TIM3 expression in circulating lymphocytes and some monocyte populations. These findings suggest that denosumab treatment by itself has modest immunomodulatory effects, but when combined with conventional cancer treatments, can lead to the induction of immunologic checkpoints.
    Journal • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    CTLA4 expression
    |
    Prolia (denosumab)
    4ms
    AOST1321: Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma (clinicaltrials.gov)
    P2, N=56, Completed, Children's Oncology Group | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Dec 2023
    Trial completion • Trial completion date
    |
    Prolia (denosumab)
    4ms
    Histological and immunohistochemical analyses of osteoclast maturation in giant cell tumor of bone. (PubMed, Pathol Res Pract)
    We identified a new differentiation stage of osteoclast maturation, intermediate cell, by comparing histological findings before and after denosumab treatment. We demonstrated that discrepancies exist between histological and molecular data and highlight the need for establishing an integrated definition of osteoclasts considering morphology and marker expression.
    Journal
    |
    JDP2 (Jun Dimerization Protein 2) • NFATC1 (Nuclear Factor Of Activated T Cells 1)
    |
    Prolia (denosumab)
    4ms
    MITO: Muscle Impact of Treating Osteoporosis (clinicaltrials.gov)
    P4, N=20, Active, not recruiting, Nami Safai Haeri | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Prolia (denosumab) • zoledronic acid
    4ms
    Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis (clinicaltrials.gov)
    P3, N=24, Completed, Amgen | Active, not recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab)
    4ms
    KEYNOTE-E86: A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (clinicaltrials.gov)
    P2, N=45, Completed, Redx Pharma Plc | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    RNF43 (Ring Finger Protein 43)
    |
    RNF43 mutation
    |
    Keytruda (pembrolizumab) • Prolia (denosumab) • zamaporvint (RXC004)
    4ms
    Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study (clinicaltrials.gov)
    P4, N=45, Active, not recruiting, University of Alabama at Birmingham | Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Jan 2024 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Prolia (denosumab)
    5ms
    AOST1321: Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma (clinicaltrials.gov)
    P2, N=56, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2023 --> Sep 2024
    Trial completion date
    |
    Prolia (denosumab)
    5ms
    Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis (clinicaltrials.gov)
    P3, N=473, Completed, Gedeon Richter Plc. | Active, not recruiting --> Completed
    Trial completion
    |
    Prolia (denosumab)
    5ms
    Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (clinicaltrials.gov)
    P4, N=155, Recruiting, Dong-A ST Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Oct 2024 --> Feb 2025
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Prolia (denosumab)