- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Vascular calcification: Molecular mechanisms and therapeutic interventions. (Pubmed Central) - Jan 10, 2023
This review aims to summarize the novel findings on molecular mechanisms and therapeutic interventions of VC, including the role of inflammatory responses, endoplasmic reticulum stress, mitochondrial dysfunction, iron homeostasis, metabolic imbalance, and some related signaling pathways on VC progression. We also conclude some recent studies on controversial interventions in the clinical practice of VC, such as calcium channel blockers, renin-angiotensin system inhibitions, statins, bisphosphonates, denosumab, vitamins, and ion conditioning agents.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date, Head-to-Head: REDUSE: Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (clinicaltrials.gov) - Jan 10, 2023
P3, N=1380, Recruiting,
We also conclude some recent studies on controversial interventions in the clinical practice of VC, such as calcium channel blockers, renin-angiotensin system inhibitions, statins, bisphosphonates, denosumab, vitamins, and ion conditioning agents. Trial completion date: Dec 2022 --> Dec 2028 | Trial primary completion date: Dec 2022 --> Jun 2026
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: The clinical effectiveness of denosumab (Prolia®) in patients with hormone-sensitive cancer receiving endocrine therapy, compared to bisphosphonates, selective estrogen receptor modulators (SERM), and placebo: a systematic review and network meta-analysis. (Pubmed Central) - Jan 10, 2023
In MPC on HAT, denosumab (relative to placebo) was effective at preventing vertebral fractures and improving BMD at the FN and LS. Moreover, in WBC on AAIT, denosumab (relative to placebo) improved BMD at the FN, LS, TH, and TRO, as well as prevent vertebral fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Metastases: Breast Cancer Exosomal microRNAs Facilitate Pre-Metastatic Niche Formation in the Bone: A Mathematical Model. (Pubmed Central) - Jan 7, 2023
We next demonstrate how breast cancer exosomal miRNAs disrupt this balance, either by increasing or by decreasing the ratio of osteoclasts/osteoblasts, which results in abnormal high bone resorption or abnormal high bone forming, respectively, and in bone weakening in both cases. Finally we consider the case of abnormally high resorption and evaluate the effect of drugs, which may increase bone density to normal level, thus protecting the bone from invasion by cancer cells.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Management of Osteoporosis Medication after Osteoporotic Fracture. (Pubmed Central) - Jan 6, 2023
Most medications for treatment of osteoporosis do not delay fracture healing and the positive effect of teriparatide on fracture healing has been confirmed. In cases where an osteoporotic fracture is diagnosed, risk assessment should be performed for selection of very high-risk patients in order to prevent subsequent fractures, and administration of anabolic agents is recommended.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Crysvita (burosumab) / Ultragenyx, Kyowa Kirin
Review: Full read review of advances in bone biology leading to drug development (denosumab, romosuzumab, Burosumab), advances in Pagets and rickets and key regulatory molecules for bone remodeling, RANK, RANKL, OPG, & sclerostin https://t.co/1d6A6MsdbJ (Twitter) - Dec 30, 2022
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment open, Surgery: Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery (clinicaltrials.gov) - Dec 30, 2022
P=N/A, N=78, Recruiting,
These findings stress the importance of accurately modelling tumour and stromal populations as a preclinical testing platform. Completed --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab Discontinuation. (Pubmed Central) - Dec 24, 2022
In this review, we evaluated the literature published over the past 1 to 3 years investigating denosumab (DMAB) discontinuation and the transition to other anti-osteoporosis therapies. Additionally, we summarized the current recommendations of international guidelines.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal: Clinical Utility of Romosozumab in the Management of Osteoporosis: Focus on Patient Selection and Perspectives. (Pubmed Central) - Dec 23, 2022
Further studies are needed to clarify the increased cardiovascular risk attributed to this drug. Romosozumab has expanded our osteoporosis armamentarium and has enabled novel approaches, including "treat to target." Future studies are needed to evaluate the optimal use sequence and to assess its safety, especially in patients with cardiovascular risk factors.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Metastases: Improving Bone Health in Patients with Metastatic Prostate Cancer with the Use of Algorithm-Based Clinical Practice Tool. (Pubmed Central) - Dec 23, 2022
The guidelines underscore current knowledge gaps that can be used to establish future research agendas. We found that incorporating an evidence-based algorithm in the order set while prescribing bone remodeling agents significantly improved our institutional clinical practice of indication-appropriate dosing and dental screening rates, and facilitated high-quality, evidence-based care to our patients with prostate cancer.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab versus zoledronic acid in elderly patients after hip fracture. (Pubmed Central) - Dec 22, 2022
Our study revealed the effectiveness and patients' persistence for two commonly used anti-osteoporosis agents after hip fracture. In this frail, elderly population, half-yearly denosumab was superior to yearly zoledronic acid in BMD and demonstrated significant higher persistence rate, indicating a potential therapeutic advantage that warrants further validation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Therapeutic alternatives for drug-associated maxillary osteonecrosis (MRONJ): reports of two clinical cases and review of the literature (Pubmed Central) - Dec 22, 2022
Drug-associated Maxillary Osteonecrosis is one of the most relevant adverse effects in treatment with antiresorptive drugs such as bisphosphonates and denosumab...Patients who develop clinical signs of great morbidity associated with MRONJ, may see their quality of life conditioned and suffer a worsening of their underlying pathology. MRONJ treatment is conditioned by the stage of the disease, its success depends on interdisciplinary management and strict medical and dental clinical follow-up, as well as rigorous monitoring to prevent or detect future recurrences early.
- |||||||||| SB16 (denosumab biosimilar) / Samsung
Trial completion: A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia (clinicaltrials.gov) - Dec 20, 2022
P3, N=457, Completed,
Completed --> Terminated; The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants Active, not recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: The Role of Bisphosphonates Prior to Denosumab Treatment on Rebound Fractures: A Mini Review. (Pubmed Central) - Dec 19, 2022
Furthermore, BP administration before denosumab treatment appears to be a reasonable strategy for reducing hyperactivation of bone remodeling. In this review, we summarize the effects of BP administration before denosumab treatment in preventing rebound fractures after denosumab discontinuation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Incidence of Decreased Bone Mineral Density Post Allogeneic Haemopoietic Stem Cell Transplant: Single Institution Retrospective Analysis () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1135;
GVHD prophylaxis most commonly used was ciclosporin (93.9%) with short course methotrexate...In a univariate analysis, older age at allo-HSCT, male, post-menopausal, high HCT-CI and myeloablative conditioning, haplo-identical SCT and post SCT cyclophosphamide GVHD prophylaxis regimen were associated with risk of low bone density...Most commonly utilized antiresorptive was zoledronic acid (64.5%), followed by denosumab (22.6%)...Conclusion : Overall, 55% of allo-SCT patients have low bone density and 5% suffer with insufficiency fracture. Routine screening and optimal management of low bone density is necessary to reduce associated risk of fracture and morbidity.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Managing Bone Health in Breast Cancer. (Pubmed Central) - Dec 13, 2022
Adjuvant endocrine treatments for hormone receptor positive breast cancer (tamoxifen, aromatase inhibitors) impact bone health...Antiresorptive medications for osteoporosis, bisphosphonates and denosumab, lower the risk of bone loss from aromatase inhibitors...This narrative review will discuss optimizing bone health in the setting of adjuvant endocrine treatments for hormone receptor positive breast cancer, and the current use of antiresorptive agents as adjuvant therapy and as bone modifying agents. Optimizing bone health in women with breast cancer during and after cancer treatment is informed by an understanding of breast cancer treatment and its skeletal impact.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone Metastasis of Breast Cancer: Molecular Mechanisms and Therapeutic Strategies. (Pubmed Central) - Dec 12, 2022
Agents inhibiting bone metastasis (such as bisphosphate and denosumab) alleviate bone destruction and improve the quality of life of breast cancer patients with bone metastasis...Additional basic and clinical studies are urgently needed, to further explore the mechanism of bone metastasis and develop new therapeutic drugs. This review presents a summary of the molecular mechanisms and therapeutic strategies of bone metastasis of breast cancer, aiming to improve the quality of life and prognosis of breast cancer patients and provide a reference for future research directions.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Progress on Denosumab Use in Giant Cell Tumor of Bone: Dose and Duration of Therapy. (Pubmed Central) - Dec 12, 2022
The efficacy and safety of denosumab against GCTB, its impact on imaging assessment, related complications, and recurrence of GCTB were previously reviewed. For further research direction, this paper reviews the progress of studies evaluating the impact of the dose and duration of denosumab therapy for GCTB.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal: Combination of Bone-Modifying Agents with Immunotarget Therapy for Hepatocellular Carcinoma with Bone Metastases. (Pubmed Central) - Dec 12, 2022
A total of 21 (33.9%) patients received TKIs (Sorafenib or Lenvatinib) alone and 41 (66.1%) received TKIs + ICIs...Prolonged OS (33 months vs. 16 months; p = 0.0048) and PFS (33 months vs. 11 months; p = 0.0027) were observed in patients with long-term use of BMAs compared with no or perioperative use of BMAs. The TKIs + ICIs combination and long-term adjuvant of BMAs may offer a survival advantage for HCC patients with BoM without severe adverse events, which requires further validations.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion, Trial completion date: Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP (clinicaltrials.gov) - Dec 12, 2022
P2, N=33, Completed,
The TKIs + ICIs combination and long-term adjuvant of BMAs may offer a survival advantage for HCC patients with BoM without severe adverse events, which requires further validations. Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Dec 2021
|
