Prolia (denosumab) / Amgen 
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  • ||||||||||  Prolia (denosumab) / Amgen
    Denosumab-Induced Severe Hypocalcemia with Recurrent Side Effects (Poster Hall, Exhibit Hall A, Level 2) -  May 6, 2024 - Abstract #ATC2024ATC_1652;    
    Denosumab-induced hypocalcemia is rare, but due to its severe effects on neuromuscular and cardiac function, patients should be counseled on the symptoms of hypocalcemia to ensure prompt medical evaluation. Ultimately, treatment for post-LTx osteoporosis should be individualized with consideration of specific medical history as well as routine monitoring of calcium levels when prescribed denosumab.
  • ||||||||||  Prolia (denosumab) / Amgen
    Effect of Denosumab on Mineral and Bone Disorder in Kidney Transplant Recipients: A Preliminary Study (Poster Hall, Exhibit Hall A, Level 2) -  May 6, 2024 - Abstract #ATC2024ATC_1644;    
    Our results suggested that Denosumab can reduce the level of bone turnover markers in kidney transplant recipients and has a good safety profile. The long-term effects on bone metabolism and bone mineral density after kidney tranplantation need to be further investigated.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Osteoporosis treatments for intervertebral disc degeneration and back pain: a perspective. (Pubmed Central) -  May 6, 2024   
    Of particular note, clinical and preclinical studies suggest that commonly prescribed osteoporosis drugs like bisphosphonates, intermittent parathyroid hormone, anti-sclerostin antibody, selective estrogen receptor modulators and anti-receptor activator of nuclear factor-kappa B ligand inhibitor denosumab may also relieve back pain. Here, we cite clinical and preclinical studies and include unpublished data to support the argument that a subset of these therapeutics for osteoporosis may alleviate low back pain by also targeting the IVD.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion, Trial completion date, Trial primary completion date:  DenosuMast: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis (clinicaltrials.gov) -  May 3, 2024   
    P3,  N=24, Completed, 
    Recruiting --> Completed | N=50 --> 25 | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Aug 2023 --> Apr 2024 Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Clinical, Journal:  3D-modeling from hip DXA shows improved bone structure with romosozumab followed by denosumab or alendronate. (Pubmed Central) -  May 2, 2024   
    3D-SHAPER analysis provides a novel technique for estimating changes in cortical and trabecular parameters from standard hip DXA images. These data add to the accumulating evidence that romosozumab improves hip bone density and structure, thereby contributing to the antifracture efficacy of the drug.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Temporal patterns of osteoclast formation and activity following withdrawal of RANKL inhibition. (Pubmed Central) -  May 2, 2024   
    Furthermore, a rise in serum TRAP and RANKL levels are detected before markers of bone turnover used in current clinical practice. These mechanistic advances may provide insight into a more defined window of opportunity to intervene with sequential therapy following denosumab discontinuation.
  • ||||||||||  Boyoubei (denosumab biosimilar) / Luye Group
    Enrollment closed:  Comparative Efficacy, Safety, PK, and Immunogenicity Study (clinicaltrials.gov) -  Apr 26, 2024   
    P3,  N=392, Active, not recruiting, 
    Surgery is the mainstay treatment for malignant GCTB. Recruiting --> Active, not recruiting
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial termination, Metastases:  SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy (clinicaltrials.gov) -  Apr 25, 2024   
    P3,  N=595, Terminated, 
    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
  • ||||||||||  Prolia (denosumab) / Amgen
    Place of Rank ligand inhibitor in giant cell tumour of bone. () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_6801;    
    The treatment is essentially surgical. Denosumab is indicated for both neoadjuvant and adjuvant use, it allows obtaining a clear clinical and radiological improvement.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Clinical, Retrospective data, Journal:  The sequential antifracturative treatment: a meta-analysis of randomized clinical trials. (Pubmed Central) -  Apr 24, 2024   
    In general, at 2?years after the switch from anabolic to antiresorptive drugs, a weighted BMD was increased at the lumbar spine, total hip, and femoral neck site. The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion, Trial completion date, Trial primary completion date:  Denosumab Sequential Therapy (clinicaltrials.gov) -  Apr 23, 2024   
    P4,  N=101, Completed, 
    The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture. Recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jul 2023
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Bone loss after discontinuation of denosumab: the devil is in the details. (Pubmed Central) -  Apr 21, 2024   
    Bone turnover markers were appropriately suppressed and bone mineral density increased in the spine and hip. This case illustrates how the overshooting phenomenon following denosumab discontinuation may be compounded by the development of secondary conditions, which can result in suboptimal response to antiresorptive osteoporosis medications.
  • ||||||||||  Bmab 1000 (denosumab biosimilar) / Biocon, Yoshindo
    Trial completion, Trial completion date, Trial primary completion date:  Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia (clinicaltrials.gov) -  Apr 17, 2024   
    P1,  N=190, Completed, 
    This case illustrates how the overshooting phenomenon following denosumab discontinuation may be compounded by the development of secondary conditions, which can result in suboptimal response to antiresorptive osteoporosis medications. Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Oct 2023
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Delayed and significant hypercalcaemia due to teriparatide therapy: a case report and review. (Pubmed Central) -  Apr 13, 2024   
    Delayed moderate to severe hypercalcaemia (serum calcium?>?3.0 mmol/l) due to teriparatide is rare but may lead to therapy withdrawal. The underlying predisposing risk factors remain unclear and highlight the importance of a routine serum calcium assessment on therapy.
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Effect of Antiresorptive Drugs on Osseointegrated Dental Implants: A Systematic Review. (Pubmed Central) -  Apr 13, 2024   
    Physicians and dentists should provide comprehensive information to patients prescribed with antiresorptive drugs, emphasizing the need for an awareness of the risks of MRONJ in the context of osseointegrated implants. A longer term of follow-up is recommended to identify and manage MRONJ around dental implants in an early manner.
  • ||||||||||  Prolia (denosumab) / Amgen
    Embolization of huge giant cell tumor () -  Apr 10, 2024 - Abstract #ECIO2024ECIO_479;    
    However, the drug caused mandibular osteonecrosis, necessitating treatment withdrawal. Due to the location, size, and marked vascularity, embolization was chosen as therapeutic option.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Enrollment closed, Trial completion date, Trial primary completion date:  Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI (clinicaltrials.gov) -  Apr 9, 2024   
    P2,  N=36, Active, not recruiting, 
    Due to the location, size, and marked vascularity, embolization was chosen as therapeutic option. Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Mar 2027 | Trial primary completion date: Feb 2024 --> Feb 2026
  • ||||||||||  AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
    Trial completion:  AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) -  Apr 8, 2024   
    P1,  N=209, Completed, 
    Early PTH monitoring was crucial, and extending the administrative period may enhance BMD outcomes compared to the general population. Active, not recruiting --> Completed
  • ||||||||||  Prolia (denosumab) / Amgen
    Enrollment change, Trial withdrawal:  Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva (clinicaltrials.gov) -  Apr 8, 2024   
    P1,  N=0, Withdrawn, 
    Active, not recruiting --> Completed N=252 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Journal:  The Dutch multidisciplinary guideline osteoporosis and fracture prevention, taking a local guideline to the international arena. (Pubmed Central) -  Apr 6, 2024   
    In our new multidisciplinary guideline osteoporosis and fracture prevention, we developed 5 "relatively new statements" that are all a crucial step forward in the optimization of diagnosis and treatment for fracture prevention. We also developed 5 flowcharts, and we suppose that this may be helpful for individual doctors and their patients in daily practice and may facilitate implementation.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Sclerotic bone: a sign of bone reaction in patients with medication related osteonecrosis of the jaw. (Pubmed Central) -  Apr 4, 2024   
    Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction associated with antiresorptive drugs such as bisphosphonates and denosumab...The pre and postoperative density showed no significant correlation to healing behaviour. The focus of the modelling osteotomy in surgical treatment of mature MRONJ lesions should be predominantly on the parts that appear necrotic and less dense in the panoramic radiograph as sclerotic areas might be an expression of bone reaction.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    P3 data, Retrospective data, Journal:  Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. (Pubmed Central) -  Apr 4, 2024   
    P3
    The focus of the modelling osteotomy in surgical treatment of mature MRONJ lesions should be predominantly on the parts that appear necrotic and less dense in the panoramic radiograph as sclerotic areas might be an expression of bone reaction. Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture.