Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Preventing osteolytic lesions and osteomyelitis in multiple myeloma. (Pubmed Central) -  Nov 18, 2022   
    Antibiotics and surgical interventions have been used to manage bone infections in most reported cases. As the bone infection risk associated with MM bone lesions become more evident, there is scope to improve patient management by mitigating this risk with prophylactic antimicrobial therapy.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Denosumab and muscle performance. (Pubmed Central) -  Nov 17, 2022   
    No abstract available No abstract available
  • ||||||||||  Evenity (romosozumab) / Astellas, Amgen, UCB
    Journal:  Romosozumab efficacy and safety in European patients enrolled in the FRAME trial. (Pubmed Central) -  Nov 16, 2022   
    P3
    TBS seemed more responsive to denosumab treatment than TBS and was independent of BMD. Among European patients in FRAME, romosozumab resulted in early and sustained risk reduction for all major fracture categories, associated with large BMD gains that continued after transition to denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Fracture risk assessment and drug holiday in a real-life setting. (Pubmed Central) -  Nov 15, 2022   
    The reporting of FRAX score in DXA scan reports may significantly increase its utilization in fracture risk assessment. We recommend comprehensive fracture risk assessment utilizing history of prevalent osteoporosis fractures, DXA assessment, and FRAX scoring.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Trial completion date, Trial primary completion date:  BAD: Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation (clinicaltrials.gov) -  Nov 10, 2022   
    P=N/A,  N=100, Recruiting, 
    We recommend comprehensive fracture risk assessment utilizing history of prevalent osteoporosis fractures, DXA assessment, and FRAX scoring. Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2022 --> Oct 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Teriparatide Followed by Denosumab in Premenopausal Idiopathic Osteoporosis: Bone Microstructure and Strength by HR-pQCT. (Pubmed Central) -  Nov 8, 2022   
    After 48M of sequential treatment, significant increases in total vBMD (tibia: p<0.001; radius: p=0.01), trabecular microstructure (p<0.05), cortical thickness (tibia: p<0.001; radius: p=0.02), and whole bone strength (p<0.02) were seen at both sites. Significant increases in total vBMD and bone strength parameters after sequential treatment with teriparatide followed by denosumab support the use of this regimen in PreMenIOP.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Osteonecrosis of the jaw among cancer patients in Denmark: risk and prognosis. (Pubmed Central) -  Nov 8, 2022   
    There were 126 deaths among cancer patients with ONJ over a maximum follow-up time of 6.4 years, resulting in a 5-year mortality of 91% (95% confidence interval 81-97%). Mortality among patients with ONJ varied by cancer site, osteonecrosis stage, and by history of trauma to the mucosa.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  The Effect of Zoledronic Acid on Bone Microarchitecture and Strength after Denosumab and Teriparatide Administration: DATA-HD Extension. (Pubmed Central) -  Nov 6, 2022   
    These findings suggest that in contrast to the largely maintained gains in DXA-derived spine and hip BMD, a single dose of ZOL was not as effective in maintaining the gains in volumetric peripheral bone density and microarchitecture produced by 15 months of overlapping treatment with denosumab and teriparatide. Alternative therapeutic approaches that can fully maintain improvements in peripheral bone parameters require further study.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Pathological RANK Signaling in Combination with TCL1 Drives a Multiple Myeloma-like Disease in Mice (ENMCC - R06-R09) -  Nov 4, 2022 - Abstract #ASH2022ASH_1410;    
    Denosumab, a monoclonal antibody blocking RANKL, is used in MM patients to reduce bone turnover...Taken together, our data implicates a direct role of B-cell intrinsic RANK signaling in MM pathogenesis. Further understanding of the molecular effects of RANK/RANKL in MM should help to optimize treatment combinations to reduce bone disease and target the malignant cells effectively, in order to provide more effective treatments to this deadly disease.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Bone health in functional hypothalamic amenorrhea: What the endocrinologist needs to know. (Pubmed Central) -  Nov 4, 2022   
    Pharmacological treatments have been studied, including androgens, insulin-like growth factor-1, bisphosphonates, denosumab, teriparatide, leptin, but none of them is currently approved for use in FHA. A timely screening for bone complications and a multidisciplinary, customized approach aiming to restore energy balance, ensure adequate protein, calcium and vitamin D intake, and reverse the detrimental metabolic-endocrine changes typical of this condition, should be the preferred approach until further studies are available.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion date, Trial primary completion date:  Osteoporosis in Primary Hyperparathyroidism (clinicaltrials.gov) -  Nov 4, 2022   
    P4,  N=40, Enrolling by invitation, 
    A timely screening for bone complications and a multidisciplinary, customized approach aiming to restore energy balance, ensure adequate protein, calcium and vitamin D intake, and reverse the detrimental metabolic-endocrine changes typical of this condition, should be the preferred approach until further studies are available. Trial completion date: May 2022 --> May 2023 | Trial primary completion date: May 2022 --> May 2023
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  The Burden of Metastatic Cancer-Induced Bone Pain: A Narrative Review. (Pubmed Central) -  Nov 2, 2022   
    Treatment options for cancer pain due to bone metastases include nonsteroidal anti-inflammatory drugs, palliative radiation, bisphosphonates, denosumab, and opioids...Studies specifically addressing cancer pain due to bone metastases, rather than general cancer pain, are limited. Additional research is needed to determine patient preferences and physician attitudes regarding choice of analgesic for moderate to severe cancer pain due to bone metastases.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial termination:  Denosumab in Primary Hyperparathyroidism (clinicaltrials.gov) -  Nov 2, 2022   
    P4,  N=8, Terminated, 
    Additional research is needed to determine patient preferences and physician attitudes regarding choice of analgesic for moderate to severe cancer pain due to bone metastases. Completed --> Terminated; Poor enrollment
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Hypercalcemia: A Review. (Pubmed Central) -  Nov 1, 2022   
    Additional causes of hypercalcemia include granulomatous disease such as sarcoidosis, endocrinopathies such as thyroid disease, immobilization, genetic disorders, and medications such as thiazide diuretics and supplements such as calcium, vitamin D, or vitamin A. Hypercalcemia has been associated with sodium-glucose cotransporter 2 protein inhibitors, immune checkpoint inhibitors, denosumab discontinuation, SARS-CoV-2, ketogenic diets, and extreme exercise, but these account for less than 1% of causes...Initial therapy of symptomatic or severe hypercalcemia consists of hydration and intravenous bisphosphonates, such as zoledronic acid or pamidronate...Mild hypercalcemia is typically asymptomatic, while severe hypercalcemia is associated with nausea, vomiting, dehydration, confusion, somnolence, and coma. Asymptomatic hypercalcemia due to primary hyperparathyroidism is managed with parathyroidectomy or observation with monitoring, while severe hypercalcemia is typically treated with hydration and intravenous bisphosphonates.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Withdrawal of Denosumab in Patients with Primary Hyperparathyroidism: A Follow-up Report of the DENOCINA-Study. (Pubmed Central) -  Oct 29, 2022   
    Asymptomatic hypercalcemia due to primary hyperparathyroidism is managed with parathyroidectomy or observation with monitoring, while severe hypercalcemia is typically treated with hydration and intravenous bisphosphonates. Evidence suggests that it is possible to at least maintain BMD, and thus potentially lower fracture risk by a short course of denosumab followed by antiresorptive therapy where applicable in patients with PHPT.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Biomarker, Review, Journal:  Mineral Bone Disorders in Kidney Disease Patients: The Ever-Current Topic. (Pubmed Central) -  Oct 28, 2022   
    We therefore examine the prognostic association between CKD-MBD and the increased risk for cardiovascular events, mortality, and CKD progression to end-stage kidney disease (ESKD). Lastly, we present specific treatments acting on CKD to prevent and treat the complications associated with secondary hyperparathyroidism (SHPT): control of hyperphosphatemia (with dietary restriction, intestinal phosphate binders, and adequate dialysis), the use of calcimimetic agents, vitamin D, and analogues, and the use of bisphosphonates or denosumab in patients with osteoporosis.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Denosumab-Related Osteonecrosis of the Jaw May Not Be a Subject of Teriparatide Treatment. (Pubmed Central) -  Oct 28, 2022   
    Lastly, we present specific treatments acting on CKD to prevent and treat the complications associated with secondary hyperparathyroidism (SHPT): control of hyperphosphatemia (with dietary restriction, intestinal phosphate binders, and adequate dialysis), the use of calcimimetic agents, vitamin D, and analogues, and the use of bisphosphonates or denosumab in patients with osteoporosis. No abstract available
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Approach to the management of β thalassemia major associated osteoporosis - A long-standing relationship revisited. (Pubmed Central) -  Oct 28, 2022   
    These include inhibitors of bone remodeling (e.g., bisphosphonates, denosumab) and stimulators of bone formation (e.g., PTHR1 agonists and sclerostin antibodies)...In this review we outline current literature on the use of anti-osteoporotic drugs in β-TM patients with osteoporosis focusing on data on the efficacy, safety, and duration of treatment. In addition, we propose a long-term management plan for β-TM -associated osteoporosis aiming at the optimal patient care for this special population.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    New P4 trial:  Denosumab vs Zoledronate After Vertebroplasty (clinicaltrials.gov) -  Oct 28, 2022   
    P4,  N=90, Recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  The role of neoadjuvant denosumab in the treatment of aneurysmal bone cysts: a case series and review of the literature. (Pubmed Central) -  Oct 26, 2022   
    Since the local re-recurrence rate after re-curettage for local recurrence was low, and the joint preservation rate and affected limb function were good, preoperative denosumab administration may be considered in patients who require downstaging to maintain good limb function (joint preservation). The use of denosumab in unresectable ABCs can cause calcification and devascularization, making safe resection more likely.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Donesta (estetrol) / Mithra
    Review, Journal:  Maintaining bone health by estrogen therapy in patients with advanced prostate cancer: a narrative review. (Pubmed Central) -  Oct 26, 2022   
    Therefore, the guidelines for ADT indicate to combine ADT routinely with bone-sparing agents such as bisphophonates, denosumab or selective estrogen receptor modulators...Encouraging effects on bone parameters have been obtained with transdermal E2 (tE2) and HDE4, in the tE2 development program (PATCH study), and in the LHRHa/HDE4 co-treatment study (PCombi), respectively. Confirmation of the beneficial effects of estrogen therapy with tE2 or HDE4 on bone health in patients with advanced PCa is needed, with special emphasis on bone mass and fracture rate.