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110 Diseases |  |
151 Trials |
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151 Trials |  |
7120 News |  |
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- Prolia (denosumab) / Amgen
RANKL-INHIBITION FOR GIANT CELL LESIONS OF THE JAW: A RETROSPECTIVE COHORT ANALYSIS () - Nov 9, 2024 - Abstract #CTOS2024CTOS_283;
High-dose denosumab is effective and safe in achieving a complete response in GCLJ within 12 months, but there is a significant risk of progression after treatment discontinuation. Therefore, using RANKL-inhibition according to the described protocol is only justified for cases where other treatments have failed, or disease may lead to disfiguring mutilating surgery.
- Prolia (denosumab) / Amgen
CURRENT INDICATIONS OF OPEN SURGERY IN PRIMARY APPENDICULAR/ PELVIC ANEURYSMAL BONE CYSTS () - Nov 9, 2024 - Abstract #CTOS2024CTOS_273;
Percutaneous sclerotherapy alone is successful in 87% of primary ABCs in this series. We recommend extended curettage surgery, in large uncontained defects, pathologic fracture or risk of fracture in high stress high risk zones or cases with partial healing or in cases with rapid progression.
- ||| Prolia (denosumab) / Amgen, CMAB807 (denosumab biosimilar) / 3SBio
Trial completion: Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers (clinicaltrials.gov) - Nov 7, 2024
P1, N=128, Completed, Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
We recommend extended curettage surgery, in large uncontained defects, pathologic fracture or risk of fracture in high stress high risk zones or cases with partial healing or in cases with rapid progression. Recruiting --> Completed
- Ayvakit (avapritinib) / Blueprint Medicines
Disease-Modifying Effects of Avapritinib in Patients with Advanced Systemic Mastocytosis: Improvements in Bone Density (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5980;
P2
Conclusions : With >3 years of follow-up, avapritinib elicited improvements in low bone density as reflected by improvements in the lumbar T-score. These results are relevant to all SM subtypes, especially ISM where the high prevalence of osteopenia and osteoporosis remains a challenging, unmet need.
- Prolia (denosumab) / Amgen
Evaluation of the Safety and Efficacy of Denosumab in Patients with Multiple Myeloma and Severe Renal Impairment; Results from an IMWG Bone Subcommittee Study (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5541;
Regarding concomitant anti-myeloma treatments, 23/98 (23.5%) of the patients were receiving bortezomib, cyclophosphamide and dexamethasone (VCd), whereas 32/98 (32.7%) were receiving anti-CD38-based therapies...Possibly 60 mg, monthly, is sufficient for these patients to prevent both SREs and hypocalcemia. However, further prospective research with larger cohort and longer follow-up period will confirm these results and refine treatment guidelines.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: High-dose denosumab (Xgeva (Pubmed Central) - Nov 5, 2024
However, further prospective research with larger cohort and longer follow-up period will confirm these results and refine treatment guidelines. This study confirmed a significant MRONJ incidence of 2.66% among high-dose denosumab recipients, highlighting the importance of careful patient selection, monitoring, and education, particularly in older and long-term treatment patients, to mitigate the risk of MRONJ.
- Livial (tibolone) / Organon, Prolia (denosumab) / Amgen
Utilization and Expenditure on Medicines for the Prevention and Treatment of Osteoporosis: A Changing Landscape () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2339;
This study highlights the changing landscape of osteoporosis prevention and treatment in Ireland, over a 13-year period. Further research into treatment adherence with these therapies is warranted, given an aging population and attendant increase in fractures with associated healthcare resource use.
- Prolia (denosumab) / Amgen
Use of Not-Recommended Cancer Treatments Among Socio-Economically Disadvantaged Medicare Beneficiaries () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1823;
However, this finding was not consistent across all disadvantaged groups or by treatment. Our results suggest that targeted approaches depending on treatment would increase the effectiveness of efforts to reduce utilization of not-recommended cancer treatments.
- | Prolia (denosumab) / Amgen
Journal: Dental Hygienists' Awareness of Medication-Related Osteonecrosis of the Jaw in Private Dental Clinics in Japan. (Pubmed Central) - Nov 4, 2024
Purpose: Medication-related osteonecrosis of the jaw (MRONJ) caused by bisphosphonates (BPs) and denosumab (Dmab) is still a major oral adverse event caused by cancer treatment and may be under-recognized by private dental services...In addition, few private clinic DHs were aware of MRONJ cases refractory to antibiotic treatment alone (p?=?.012). These findings suggest that private clinic DHs have less knowledge of MRONJ than those in cancer base hospitals.
- | Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors (clinicaltrials.gov) - Nov 4, 2024
P=N/A, N=100, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
These findings suggest that private clinic DHs have less knowledge of MRONJ than those in cancer base hospitals. Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
- ||||||| Prolia (denosumab) / Amgen
Trial completion: Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) - Nov 3, 2024
P=N/A, N=517991, Completed, Sponsor: Amgen
Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025 Active, not recruiting --> Completed
- Prolia (denosumab) / Amgen
Exploring rates of prescribing calcium and vitamin D supplementation in cancer patients receiving bone resorptive agents (Halls 1 & 2) - Nov 3, 2024 - Abstract #COSA2024COSA_452;
This small observational study has demonstrated that patient reports of being prescribed calcium and vitamin D supplementation are not aligned with current guidelines. Further research in this space would examine gaps in processes to improve on prescribing rates and optimize patient care.
- Trodelvy (sacituzumab govitecan-hziy) / Gilead
Excellent and Prolonged Response to Sacituzumab-govitecan in Triple Negative mBC (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1599;
- Prolia (denosumab) / Amgen
Phase II, Single Arm Trial of Denosumab's Effect on Breast Density and Breast Tissue Biomarkers (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_1102;
- Current Endocrine/Systemic Treatment Landscape of ER+ HER2 negative early-stage Breast Cancer: First Data from the RESCUE trial (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_564;
- Kisqali (ribociclib) / Novartis
Vitiligo-like reaction in a patient with metastatic RH+/HER2-negative breast cancer treated with ribociclib: A case report and literature review (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_496;
- Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Targeting Brain Metastasis: The Success of Trastuzumab-Deruxtecan in HER2+ Cancers: A Case Report (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_489;
- Prolia (denosumab) / Amgen
Rediscovering Denosumab: Immunomodulation of the Tumor Microenvironment in Early-Stage Breast Cancer through RANK Pathway Inhibition (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_307;
- Rate of Fracture After Discontinuation of Bone Modifying Agents in Patients with Early-Stage Breast or Prostate Cancer on Hormonal Therapy (Halls 2-3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_304;
- Prolia (denosumab) / Amgen
Osteonecrosis of the jaw (ONJ) in patients with metastatic breast cancer treated with denosumab in a randomized phase III trial comparing 4 vs. 12 weekly administration (REDUSE, SAKK 96/12) (Hemisfair Ballroom 3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_225;
- Keytruda (pembrolizumab) / Merck (MSD)
Anti-RANKL bone resorptive therapy increases immune-related adverse events (irAE) in breast cancer patients (pts) treated with pembrolizumab. (Hemisfair Ballroom 3) - Nov 1, 2024 - Abstract #SABCS2024SABCS_223;
- | Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Romosozumab following denosumab improves lumbar spine bone mineral density and trabecular bone score greater than denosumab continuation in postmenopausal women. (Pubmed Central) - Nov 1, 2024
Further research in this space would examine gaps in processes to improve on prescribing rates and optimize patient care. For 12
- ||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Trial completion: Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND (clinicaltrials.gov) - Oct 31, 2024
P3, N=532, Completed, Sponsor: Alvotech Swiss AG
For 12 Active, not recruiting --> Completed
- | Prolia (denosumab) / Amgen
Journal: Parathyroid Carcinoma Complicated by Parathyromatosis and Refractory Hypercalcemia. (Pubmed Central) - Oct 31, 2024
Despite treatment with cinacalcet and zoledronic acid, her hypercalcemia persisted until denosumab produced a dramatic response (serum calcium dropping from 16.7 to 7.9 mg/dL; PTH 1,168 pg/mL). However, she remains at risk for progressive local disease and potential distant metastases.
- Prolia (denosumab) / Amgen
Denosumab improves clinical benefit of PD1 inhibitors in metastatic melanoma (MM) presumably via a suppressive effect on immunoregulatory myeloid cell populations (Exhibit Halls AB - George R. Brown Convention Center) - Oct 30, 2024 - Abstract #SITC2024SITC_1919;
P2
However, she remains at risk for progressive local disease and potential distant metastases. We conducted a study of denosumab (D) induction followed by a combination with nivolumab (N) in PD1 inhibitor (PDi)-na
- || Prolia (denosumab) / Amgen
Review, Journal: Osteoarthritis year in review 2024: Epidemiology and therapy. (Pubmed Central) - Oct 27, 2024
Notably, the authors were particularly interested in recent high-quality methodology randomised controlled trials focusing on hand (methotrexate, denosumab, colchicine, topical bethamethasone) and knee OA with conflicting results about stem cells injection. These findings collectively contribute to show the growing burden of OA, but also to help the understanding of OA pathophysiology and inform ongoing efforts to enhance management for people with OA.
- | Prolia (denosumab) / Amgen
Journal: A Multi-Center Observation Study on Medication-Related Osteonecrosis of the Jaw (MRONJ) in Patients with Osteoporosis, and Other Non-Malignant Bone Diseases, in Northwestern Italy over 16 Years. (Pubmed Central) - Oct 26, 2024
In this study, we describe epidemiological and clinical characteristics of patients, and the drug most frequently involved in MRONJ cases in our region over a long period, allowing a comprehensive view of the progression of the disease. Greater collaboration among specialists is needed for correct and early diagnosis to improve measures potentially reducing disease incidence and to limit quality of life deterioration in patients with osteoporosis and other non-malignant diseases.
- | Prolia (denosumab) / Amgen
Journal: Atypical presentation of PJP: hypercalcemia and kidney injury in an allogeneic stem cell transplant recipient. (Pubmed Central) - Oct 25, 2024
- | Prolia (denosumab) / Amgen
Journal: Evaluation of Osteogenic Phenotype in Postmenopausal Women receiving Anabolic and Antiresorptive Osteoporosis Therapies. (Pubmed Central) - Oct 24, 2024
Since concomitant therapy with denosumab and teriparatide has shown promise in this respect, investigations were undertaken to explore whether the changes in osteogenic phenotype could provide insight into the cellular and molecular mechanism of this effect...This was associated with an increased in bone marrow stromal cell expression of LGR6 (Leucine Rich Repeat Containing G Protein-Coupled Receptor 6), a stem cell marker and activator of the canonical Wnt signaling pathway. These data suggest that enhancement of canonical Wnt signaling contributes to the increase in osteoprogenitors and consequently an increase in bone density in postmenopausal women receiving combination therapy for osteoporosis.
- || Prolia (denosumab) / Amgen
Review, Journal: Exploring Denosumab's potential in aneurysmal bone cyst treatment: A scoping review. (Pubmed Central) - Oct 24, 2024
Concerns exist about tumour recurrence and rebound hypercalcemia, necessitating careful monitoring, longer follow-up, and prophylactic measures. Prospective clinical trials are warranted for deeper insights.
- | Prolia (denosumab) / Amgen
Enrollment open, Trial completion date, Trial primary completion date: Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture (clinicaltrials.gov) - Oct 23, 2024
P=N/A, N=2478, Recruiting, Sponsor: Peking Union Medical College Hospital
Prospective clinical trials are warranted for deeper insights. Not yet recruiting --> Recruiting | Trial completion date: Dec 2025 --> Sep 2026 | Trial primary completion date: Dec 2025 --> Sep 2026
- || Prolia (denosumab) / Amgen
Review, Journal: Extra-osseous Roles of the RANK-RANKL-OPG Axis with a Focus on Skeletal Muscle. (Pubmed Central) - Oct 23, 2024
Targeting RANKL may be a novel therapy in ameliorating loss of muscle mass and function. More research is warranted to determine the causality of the RANK-RANKL-OPG axis in extra-osseous tissues, especially those affected by aging.
- | Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Treatment of glucocorticoid-induced osteoporosis with concurrent denosumab and romosozumab: a case report. (Pubmed Central) - Oct 23, 2024
However, there is limited experience with the combination of denosumab and romosozumab, which may be an alternative antiresorptive/anabolic regimen for individuals who are not candidates for PTH receptor agonists. In this case, we present a young man with glucocorticoid-induced osteoporosis who could not tolerate a daily injectable anabolic and who experienced improvement in bone mineral density with concurrent denosumab and off-label romosozumab administration.
- | Prolia (denosumab) / Amgen
Journal: IMPC-based screening revealed that ROBO1 can regulate osteoporosis by inhibiting osteogenic differentiation. (Pubmed Central) - Oct 23, 2024
The utilization of denosumab in treating osteoporosis highlights promising prospects for osteoporosis intervention guided by gene targets...Our study provides several novel molecular mechanisms involved in the pathogenesis of osteoporosis. ROBO1 is a potential target for osteoporosis intervention.
- || Retrospective data, Review, Journal: Falls and fractures in men with prostate cancer taking second-generation androgen receptor antagonists: A retrospective chart review. (Pubmed Central) - Oct 22, 2024
This could be due to the small patient population or the patient's comorbidities such as osteoporosis, bone metastases, or neuropathy. Fall/fracture risk with enzalutamide and other risk factors for fall and fracture should be considered when discussing treatment and developing a monitoring plan.
- | Prolia (denosumab) / Amgen
Journal: Mapping RANKL- and OPG-expressing cells in bone tissue: the bone surface cells as activators of osteoclastogenesis and promoters of the denosumab rebound effect. (Pubmed Central) - Oct 19, 2024
ISH confirmed co-expression of Mmp13 and Tnfsf11 in bone surface cells of both vehicle- and OPG:Fc-treated mice. Under physiological conditions of human/mouse bone, RANKL is expressed mainly by osteoprogenitors proximate to the osteoclasts, while OPG is expressed mainly by osteocytes and bone-forming osteoblasts.
- | Journal, Surgery: Osteoporosis Treatment and Outcomes in Patients Undergoing Adult Spinal Deformity Surgery. (Pubmed Central) - Oct 19, 2024
Pharmacological treatment appears beneficial in managing osteoporosis-related surgical risks. These findings highlight the importance of identifying and treating osteoporosis in ASD patients to minimize complications.
- || Prolia (denosumab) / Amgen
Review, Journal: Bone complications of cancer treatment. (Pubmed Central) - Oct 17, 2024
(1)Cancer treatment-related osteonecrosis is primarily linked to the use of radiation therapy and certain chemicals, such as bisphosphonates, denosumab, antiangiogenic agents, and immunomodulators...These treatment-related bone disorders have a considerable adverse impact on the prognosis of cancer patients. Hence, it is imperative to prioritize the bone health of patients undergoing cancer treatment and give it further attention.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: Safety of In-hospital Parenteral Antiosteoporosis Therapy Following a Hip Fracture: A Retrospective Cohort. (Pubmed Central) - Oct 17, 2024
In-hospital parenteral osteoporosis treatment was rarely associated with fever or renal function impairment but was associated with hypocalcemia. Posttreatment hypocalcemia risk did not vary significantly between patients receiving ZOL or Dmab.
- | Prolia (denosumab) / Amgen
New P4 trial: RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis (clinicaltrials.gov) - Oct 16, 2024
P4, N=120, Recruiting, Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
- ||||| Prolia (denosumab) / Amgen
Trial completion date, Trial initiation date, Trial primary completion date: Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia (clinicaltrials.gov) - Oct 16, 2024
P3, N=440, Not yet recruiting, Sponsor: Xentria, Inc.
Posttreatment hypocalcemia risk did not vary significantly between patients receiving ZOL or Dmab. Trial completion date: Oct 2026 --> Oct 2027 | Initiation date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2026 --> Oct 2027
- | Prolia (denosumab) / Amgen
Journal: Denosumab - protection for bone and beyond? (Pubmed Central) - Oct 15, 2024
Trial completion date: Oct 2026 --> Oct 2027 | Initiation date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2026 --> Oct 2027 No abstract available
- Prolia (denosumab) / Amgen
COMPARISON OF DENOSUMAB AND BISPHOSPHONATES FOR TENOFOVIR-INDUCED OSTEOPOROSIS IN PATIENTS WITH CHRONIC HEPATITIS B () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1057;
In CHB patients with TDF-induced osteoporosis, denosumab outperformed bisphosphonates in the lumbar spine BMD recovery but was comparable in the hip at year 1. The reduction in P1NP level was also more prominent in the denosumab group.
- || Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Clinical, Review, Journal: A practical approach for anabolic treatment of bone fragility with romosozumab. (Pubmed Central) - Oct 14, 2024
The reduction in P1NP level was also more prominent in the denosumab group. Based on the available evidence, romosozumab could be proposed as ideal drug in several clinical settings, such as non-fractured post-menopausal women at very-high risk of fractures, patients with recent hip fracture, patients non responder to bisphosphonates and short-term denosumab therapy.
- | Prolia (denosumab) / Amgen
Journal: Dose-specific effects of denosumab on serum calcium levels in patients with osteoporosis and various renal functions. (Pubmed Central) - Oct 11, 2024
Based on the available evidence, romosozumab could be proposed as ideal drug in several clinical settings, such as non-fractured post-menopausal women at very-high risk of fractures, patients with recent hip fracture, patients non responder to bisphosphonates and short-term denosumab therapy. The magnitude of serum calcium decrease following subsequent dose(s) was smaller than that following the initial dose of denosumab among patients with osteoporosis and advanced CKD.
- || Prolia (denosumab) / Amgen
Review, Journal: Diabetic Charcot neuroarthropathy: A threat to both limb and life. (Pubmed Central) - Oct 9, 2024
Denosumab is potentially an efficacious, if unproven, therapy to accelerate healing...Mortality is also increased with DCN, especially in the presence of a foot ulcer. To avoid the recurrence of DCN and especially to lower the risk of the recurrence of a foot ulcer recurrence reconstructive, surgery may be needed.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal, Checkpoint inhibition: Synergistic effect between denosumab and immune checkpoint inhibitors (ICI)? A retrospective study of 268 patients with ICI and bone metastases. (Pubmed Central) - Oct 9, 2024
This retrospective investigation supports the notion of potential benefits associated with sequential administration of ICI and denosumab, although statistical significance was not achieved. Future studies, including prospective trials or updated retrospective analyses, focusing on cancers treated with first-line immunotherapy, could provide further insights into this therapeutic approach.
- ||| P4 data, Journal, Adverse events: Neuronal toxicity of monoclonal antibodies (mAbs): an analysis of post-marketing reports from FDA Adverse Event Reporting System (FAERS) safety database. (Pubmed Central) - Oct 7, 2024
Our study enhances understanding of mAb neurological safety. Disproportionality signal analysis provides valuable evidence for risk mitigation.
- | Prolia (denosumab) / Amgen
Journal: Anti-resorptive therapy and MRONJ. A survey of the Italian Society of Periodontology and Implantology. (Pubmed Central) - Oct 7, 2024
Disproportionality signal analysis provides valuable evidence for risk mitigation. This survey highlights the need to develop a "dedicated" program both for dentists and prescribers to improve the level of cooperation and to increase the level of awareness of patients treated with anti-resorptive agents.
- | Prolia (denosumab) / Amgen
Journal: The predictive value of albumin to alkaline phosphatase ratio for vertebral refractures in postmenopausal women. (Pubmed Central) - Oct 6, 2024
This survey highlights the need to develop a "dedicated" program both for dentists and prescribers to improve the level of cooperation and to increase the level of awareness of patients treated with anti-resorptive agents. AAPR is an independent risk factor for OVRFs after PVA in postmenopausal women, and it can be used as an effective index to predict OVRFs.