Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Does Denosumab Change the Giant Cell Tumor Treatment Strategy? Lessons Learned From Early Experience. (Pubmed Central) -  Sep 18, 2019   
    We believe that denosumab treatment before resection of a large tumor aids resection without tumor spillage, particularly where important structures like the neurovascular bundle are dissected away from the tumor margin, although we cannot confirm that it helps lower the incidence of recurrence. We are concerned regarding the malignancy-causing potential from our observation in one patient as well as reports of this by others and recommend judicious use of this drug in patients with GCT.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Denosumab and breast cancer risk in postmenopausal women: a population-based cohort study. (Pubmed Central) -  Sep 14, 2019   
    We are concerned regarding the malignancy-causing potential from our observation in one patient as well as reports of this by others and recommend judicious use of this drug in patients with GCT. These findings suggest a potential protective effect of ever denosumab use on breast cancer risk in a cohort of older women previously treated with bisphosphonates.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Utilization pattern of bone targeting agents in patients with solid tumour in Taiwan, Hong Kong and Korea (Poster Area (Hall 4)) -  Sep 11, 2019 - Abstract #ESMO2019ESMO_2118;    
    The study provided fundamental information for subsequent evaluations of how this variation in BTA use may be associated with optimal clinical outcomes in Asia. Legal entity responsible for the study: School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Patterns of care for patients with metastatic bone disease in solid tumors: A cross-sectional study (SAKK 95/16) (Poster Area (Hall 4)) -  Sep 11, 2019 - Abstract #ESMO2019ESMO_1797;    
    The number of SREs was low irrespective of BTA treatment or risk classification for SREs, which may reflect a high impact of systemic cancer treatment on SRE reduction, or a selection of the pts according to risk factors not defined as the ones in the literature. Legal entity responsible for the study: SAKK.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Review, Journal:  Bone Metastases in Neuroendocrine Neoplasms: From Pathogenesis to Clinical Management. (Pubmed Central) -  Sep 11, 2019   
    The current knowledge on BMs in gastro-entero-pancreatic (GEP) and bronchopulmonary (BP) NENs is still scant and is derived from a few retrospective studies and case reports. This review aims to perform a critical analysis of the evidence regarding the role of BMs in GEP- and BP-NENs, focusing on the molecular mechanisms underlining the development of BMs, as well as clinical presentation, diagnosis, and treatment of BMs, in an attempt to provide suggestions that can be used in clinical practice.
  • ||||||||||  abaloparatide (BA058) / Radius, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Treatment of osteoporosis: whom, how and for how long? (Pubmed Central) -  Sep 11, 2019   
    For patients with lower risk, a period off treatment might be considered after this initial course to minimize the risks associated with more prolonged treatment, but this only applies to bisphosphonates and not denosumab or teriparatide. This review discusses strategies for case finding of patients at risk, currently available treatment options, recent developments in pharmacological management and duration of treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Atypical distal tibial shaft fractures in a patient with bilateral TKA and antiresorptive treatment (Pubmed Central) -  Sep 11, 2019   
    Other localizations of fractures of this genesis, especially if occurring bilaterally, are rare. This case reports about the diagnosis, treatment and process of a 76-year old patient, who within a 4‑month period suffered from bilateral distal tibial shaft fractures, after years of treatment with bisphosphonates, strontium ranelate and denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen
    New P4 trial:  Osteoporosis in Primary Hyperparathyroidism (clinicaltrials.gov) -  Sep 11, 2019   
    P4,  N=40, Recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Review, Journal:  Atypical femoral fractures from bisphosphonate in cancer patients - Review. (Pubmed Central) -  Sep 10, 2019   
    In the future, it will be important to explore the effect of continuous vs. intermittent exposure, cumulative dose and length of exposure on the incidence of this complication. Herein, we review the epidemiology, risk factors, management options and proposed mechanisms of pathogenesis of atypical femur fractures.
  • ||||||||||  Prolia (denosumab) / Amgen
    Enrollment open:  TRIDENT: RANKL Inhibition and Mammographic Breast Density (clinicaltrials.gov) -  Sep 9, 2019   
    P2,  N=210, Recruiting, 
    Herein, we review the epidemiology, risk factors, management options and proposed mechanisms of pathogenesis of atypical femur fractures. Not yet recruiting --> Recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Denosumab. (Pubmed Central) -  Sep 8, 2019   
    Not yet recruiting --> Recruiting No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  The sequential therapy of romosozumab followed by denosumab for osteoporosis. (Pubmed Central) -  Sep 8, 2019   
    In the pivotal Fracture study in postmenopausal women with osteroposis(FRAME)and the extension trial, 12 months of romosozumab led to persistent fracture, especially new vertebral fracture, reduction benefit and ongoing BMD(bone mineral density)gains when follow 24 months of denosumab. The sequence therapy of romosozumab followed by denosumab may be a promising regimen for the treatment of osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Do femoral fractures in adult patients with osteogenesis imperfecta imitate atypical femoral fractures? A case series. (Pubmed Central) -  Sep 6, 2019   
    Atypical femoral fractures (AFFs) are low-energy femoral fractures with characteristic radiological features and a suspected relation to treatment with bisphosphonate (BP) or denosumab...The radiologic appearance of femoral fractures may be different in patients with osteogenesis imperfecta (OI) and patients with osteoporosis, thus imitate atypical femoral fractures (AFF). We found that bone deformity, collagen deficiencies, and alterations in bone mineralization may cause femoral fractures that imitate AFFs even in the absence of antiresorptive treatment.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  Denosumab improves clinical manifestations of hypophosphatemic osteomalacia by adefovir-induced Fanconi syndrome: a case report. (Pubmed Central) -  Sep 6, 2019   
    Although denosumab is not generally an appropriate treatment for acquired Fanconi syndrome, it may be useful for patients who have hypophosphatemic osteomalacia due to adefovir dipivoxil-induced Fanconi syndrome associated with excessive bone resorption. However, clinicians should keep in mind that if denosumab is administered to patients with hypophosphatemic osteomalacia accompanied by excessive bone resorption, adequate vitamin D and/or phosphate supplementation should be done before administration of denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, NN1213 / Novo Nordisk
    Trial primary completion date:  REaCT-BTA: 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases (clinicaltrials.gov) -  Sep 6, 2019   
    P4,  N=250, Active, not recruiting, 
    However, clinicians should keep in mind that if denosumab is administered to patients with hypophosphatemic osteomalacia accompanied by excessive bone resorption, adequate vitamin D and/or phosphate supplementation should be done before administration of denosumab. Trial primary completion date: Apr 2019 --> Sep 2019
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (clinicaltrials.gov) -  Sep 6, 2019   
    P1,  N=75, Recruiting, 
    Trial primary completion date: Apr 2019 --> Sep 2019 Trial completion date: May 2020 --> Sep 2020 | Trial primary completion date: May 2020 --> Sep 2020
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment open:  Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration (clinicaltrials.gov) -  Sep 5, 2019   
    P4,  N=36, Recruiting, 
    Trial completion date: May 2020 --> Sep 2020 | Trial primary completion date: May 2020 --> Sep 2020 Not yet recruiting --> Recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Enrollment closed:  Denosumab Versus Bisphosphonates (Alendronate) in GIOP (clinicaltrials.gov) -  Sep 4, 2019   
    P4,  N=220, Active, not recruiting, 
    Clinical Trials.gov Identifier: NCT03324932, Japan Registry of Clinical Trial (jRCT): CRB5180001. Recruiting --> Active, not recruiting
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Asclera (polidocanol) / Merz Pharma
    Clinical, Journal:  Aneurysmal bone cyst: A review of 65 patients. (Pubmed Central) -  Aug 30, 2019   
    Minimally invasive methods such as selective embolization and injections of sclerosing agents may result in healing or at least in tolerable persistence of residual lesions but needs repetitive treatments and does not show homogenous results throughout the institutions. Denosumab appears to be an additional option, especially in surgically critical locations such as the spine or the sacrum.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evomate (raloxifene hydrochloride) / Shreya Life Sciences
    Clinical, Observational data, Journal, Real-World Evidence:  Changes in bone mineral density (BMD): a longitudinal study of osteoporosis patients in the real-world setting. (Pubmed Central) -  Aug 30, 2019   
    Osteoporosis patients are unlikely to improve femoral neck T-scores over 1.2 years. Additional studies are needed to determine the optimal time to repeat BMD testing while receiving osteoporosis treatment and to determine whether fracture risk is reduced in patients who achieve target T-scores.
  • ||||||||||  Avastin (bevacizumab) / Roche
    Retrospective data, Journal:  Evaluation of healing time of osteochemonecrosis of the jaw after surgery: Single-center retrospective study and review of the literature (Pubmed Central) -  Aug 28, 2019   
    Our study shows that the postoperative healing rate of ONJ lies between 57 and 66.7 % at 6 months and that this rate was optimized in the order of 10 % to 12months and stable at 18months postoperatively. The ONJ of our series were partially or fully linked to other drugs than bisphosphonates in 70 % of the cases: 50 % were related to denosumab, alone or in combination and 35 % were related to an association with antiangiogenics, bevacizumab mainly.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Update MRONJ and perspectives of its treatment. (Pubmed Central) -  Aug 28, 2019   
    ...Not only bisphosphonates but also new drugs like Denosumab may induce osteonecrosis of the jaw as a side effect...Furthermore, diagnostic modalities and treatment options as well as new and innovative strategies are discussed. The major key factor to avoid the occurrence of ARONJ still remains the implementation of throughout preventive measures.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Review, Journal:  RANK-RANKL Signaling in Cancer of the Uterine Cervix: A Review. (Pubmed Central) -  Aug 28, 2019   
    Abundant circumstantial evidence suggests that RANKL inhibition may (partially) reverse an immunosuppressive status. The use of denosumab, a monoclonal antibody directed to RANKL, as an immunomodulatory strategy is an attractive concept which should be further explored in combination with immune therapy in patients with cervical cancer.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Journal:  Underestimation of vertebral fractures after Denosumab discontinuation. (Pubmed Central) -  Aug 25, 2019   
    We think that the difference between the previously published data and the actual study is due to the fact that the duration of the follow-up was not sufficient to capture all the vertebral fractures. Moreover, we found that this study has methodological caveats.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
    Clinical, Journal:  A Case of Intracranial Epidural Abscess Secondary to Medication-Related Osteonecrosis of the Jaw (Pubmed Central) -  Aug 25, 2019   
    Recently, bisphosphonate and denosumab have been widely used for the treatment of bone metastasis of breast cancer...The patient died of the condition, although chemotherapy was effective. The mechanism of and therapy for MRONJ have not been clarified; therefore, its prevention should be emphasized.