- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Revlimid (lenalidomide) / BMS, Darzalex IV (daratumumab) / J&J
Clinical, Review, Journal, IO biomarker: Bone Marrow Microenvironment Interplay and Current Clinical Practice in Multiple Myeloma: A Review of the Balkan Myeloma Study Group. (Pubmed Central) - Sep 11, 2021 The introduction of several T-cell-based immunotherapeutic modalities, such as chimeric-antigen-receptor-transduced T cells (CAR T cells) and bispecific antibodies, represents a new perspective in MM treatment affecting TME immune evasion. The optimal treatment approach to MM patients should be adjusted to all aspects of the individual profile including the TME niche.
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Clinical, P3 data, Journal, HEOR: Bone Health Outcomes from the International, Multicenter, Randomized, Phase 3, Placebo-Controlled D-CARE Study Assessing Adjuvant Denosumab in Early Breast Cancer. (Pubmed Central) - Sep 8, 2021 P3 78.7% of the patients were female and average age was 61.4 years +/- 13.9 years. The exploratory bone endpoints indicate the benefits of denosumab treatment in patients with high-risk early breast cancer, supporting the expected bone health benefits contributed by denosumab.
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Clinical, Journal: Chondroblastoma's Lung Metastases Treated with Denosumab in Pediatric Patient. (Pubmed Central) - Sep 1, 2021 Here, we report a case of a 16-year-old male chondroblastoma of the left humerus with bilateral lung metastases at presentation and progressing during follow-up, treated with denosumab for almost 2 years. We confirm that denosumab treatment can be effective in controlling chondroblastoma metastasis and it has been a safe procedure in an adolescent patient.
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Trial completion: Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients (clinicaltrials.gov) - Sep 1, 2021 P=N/A, N=73, Completed, We confirm that denosumab treatment can be effective in controlling chondroblastoma metastasis and it has been a safe procedure in an adolescent patient. Active, not recruiting --> Completed
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Clinical, Journal: Denosumab for craniofacial fibrous dysplasia: duration of efficacy and post-treatment effects. (Pubmed Central) - Aug 29, 2021 Pain relief and lesion stability continued for 2 years following treatment, and symptom recurrence coincided with increased bone turnover markers and decreased lesion density back to pre-treatment levels. This case highlights the importance of considering the duration of efficacy when treating patients with FD and other nonresectable skeletal neoplasms that require long-term management.
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Clinical, Journal: Remarkable loss of bone mineral density in 6 months after denosumab discontinuation: a case report. (Pubmed Central) - Aug 28, 2021 In recent years, several studies have shown that multiple vertebral fractures sometimes occur after denosumab discontinuation. Herein, we report the case of a 63-year-old woman with osteoporosis who lost 60% of lumbar bone mineral density acquired during osteoporosis treatment after 6 months of denosumab discontinuation.
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Journal: Giant cell tumour of hand bones: outcomes of treatment. (Pubmed Central) - Aug 25, 2021 Recurrence occurred in two of nine patients treated with curettage, one of three with resection and none of five with ray or digit amputation. Both curettage and resection/amputation are acceptable treatment options for the rare condition of giant cell tumour of bone in the hand, with a need to individualize treatment decisions based on the site and extent of disease to minimize treatment morbidity while maximizing disease control.Level of evidence: IV.
- |||||||||| HS-20090 (denosumab biosimilar) / Jiangsu Hansoh Pharma
Enrollment open: Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia (clinicaltrials.gov) - Aug 24, 2021 P1, N=174, Recruiting, Both curettage and resection/amputation are acceptable treatment options for the rare condition of giant cell tumour of bone in the hand, with a need to individualize treatment decisions based on the site and extent of disease to minimize treatment morbidity while maximizing disease control.Level of evidence: IV. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Fracture risk in systemic lupus erythematosus patients over 28 years. (Pubmed Central) - Aug 21, 2021 Not yet recruiting --> Recruiting We found no significant association between glucocorticoid treatment and fragility fractures in our group of patients; however, a prospective study including more patients not treated with CS would be necessary to confirm these results.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Hypocalcaemia following denosumab in prostate cancer: a clinical review. (Pubmed Central) - Aug 20, 2021 Modifiable risk factors should be corrected before denosumab administration. In men with active osteoblastic metastases, consideration should be given to delay denosumab treatment until underlying disease activity is controlled, and/or be administered with close monitoring and proactive treatment with calcium and calcitriol.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Comparative Effect of Zoledronate at 6 Versus 18 Months Following Denosumab Discontinuation. (Pubmed Central) - Aug 20, 2021 P4 A ZOL infusion 18 months following the last Dmab injection is still useful in terms of BMD maintenance and BTM suppression. However, there is no clear clinical benefit compared to the early infusion, while any theoretical advantage is counterbalanced from the expected bone loss, especially at the LS, and the risk of rebound-associated fractures.Trial Registration: NCT02499237; July 16, 2015.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone Mineral Disease After Kidney Transplantation. (Pubmed Central) - Aug 20, 2021 Treatment alternatives for CKD-MBD after transplantation include minimization of corticosteroids, use of calcium and vitamin D supplements, antiresorptives (bisphosphonates or Denosumab) and osteoformers (synthetic parathyroid hormone). As both mineral metabolism and bone disorders lead to increased morbidity and mortality, the presence of these changes after transplantation has to be prevented (if possible), minimized, diagnosed, and treated as soon as possible.
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Retrospective data, Review, Journal: What's new in musculoskeletal oncology. (Pubmed Central) - Aug 19, 2021 Finally, the life expectancy of patients is the most important factor in determining the optimal surgical procedure for patients with impending or pathological fractures of the long bone due to metastatic bone tumors. Elevated C-reactive protein level was found to be an independent poor prognostic factor at 1 year after surgery for long bone metastases.
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Trial completion date, Trial primary completion date: Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (clinicaltrials.gov) - Aug 18, 2021 P2, N=28, Recruiting, Elevated C-reactive protein level was found to be an independent poor prognostic factor at 1 year after surgery for long bone metastases. Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Nov 2021 --> Nov 2022
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Review, Journal: The molecular etiology and treatment of glucocorticoid-induced osteoporosis. (Pubmed Central) - Aug 14, 2021 The selective estrogen receptor modulator can only be used under specific condition for postmenopausal women who have GIOP but fail to the regular GIOP treatment or have specific therapeutic contraindications. In this review, we focus on the molecular etiology of GIOP and the molecular pharmacology of the therapeutic drugs used for GIOP treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Which treatment to prevent an imminent fracture? (Pubmed Central) - Aug 14, 2021 Ibandronate is the only one without demonstrated efficacy against non-vertebral and hip fractures...Compared with risedronate, which significantly reduces the rate of hip fractures, zoledronate, denosumab, teriparatide, abaloparatide and romosozumab are more efficient for vertebral fractures but not for non-vertebral or hip fractures reduction...In patients at high risk of imminent fracture, starting therapy with potent antiresorptive agents or with an anabolic agent seems most appropriate to promptly reduce the fracture risk. Available NMA/MA suggest that, compared to zoledronate and denosumab, anabolic agents have a higher efficacy for vertebral fractures but head-to-head studies are lacking.
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Journal, Combination therapy: RANKL-Targeted Combination Therapy with Osteoprotegerin Variant Devoid of TRAIL Binding Exerts Biphasic Effects on Skeletal Remodeling and Antitumor Immunity. (Pubmed Central) - Aug 14, 2021 In combination with agonistic death receptor (DR5) activation, the OPG therapy significantly increased both bone remolding and long-term antitumor immunity, protecting mice from breast cancer relapse and osteolytic pathology. With limitations, cost, and toxicity issues associated with the use of denosumab, bisphosphonates, and chemotherapy for bone metastatic disease, use of OPG combination could offer a viable alternate therapeutic approach.
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