Prolia (denosumab) News

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|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Systemic drug photosensitivity - culprits, impact and investigation in 122 patients. (Pubmed Central) - Oct 1, 2021
Classically described photosensitizing drugs such as thiazides and quinine remain common offenders, while emerging culprits include biologics such as TNF-a inhibitors and proton-pump-inhibitors. There is very large impact on life quality; identification facilitates measures including drug cessation and implementation of appropriate photoprotection.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Antiresorptive and anabolic medications used in the perioperative period of patients with osteoporosis undergoing spine surgery: their impact on the biology of fusion and systematic review of the literature. (Pubmed Central) - Oct 1, 2021
The advent of newer agents represents an area for further exploration, especially due to the current paucity of controlled investigations. It is imperative for spine surgeons to understand the mechanisms of action of these drugs and their effects on biology of fusion.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: Osteoporosis treatment in patients undergoing spinal fusion: a systematic review and meta-analysis. (Pubmed Central) - Oct 1, 2021
In addition, they show that teriparatide may have superior benefits in spinal fusion during long-term monitoring as compared to those with bisphosphonates. Bisphosphonates may be better suited in preventing VCFs postoperatively in addition to minimizing postoperative disability and pain.

||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
New P2/3 trial:  Denosumab and Screw Fixation for Osteoporotic Compression Fracture (clinicaltrials.gov) -  Sep 30, 2021
P2/3, N=125, Recruiting,  Sponsor: Shenzhen People's Hospital

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Antimicrobial peptide gene expression in medication-related osteonecrosis of the jaw. (Pubmed Central) - Sep 30, 2021
Bisphosphonates and denosumab are commonly used antiresorptive therapies in patients with bone metastasis and osteoporosis...This finding is similar to previously described upregulated expression of human defensins in patients with MRONJ after bisphosphonates treatment. This suggests that the elevated expression of defensins may be at least a part of the mechanism underlying the pathogenesis of osteonecrosis induced by antiresorptive therapies, which can serve as a new target for potential treatment of MRONJ.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia? (Pubmed Central) - Sep 30, 2021
• Denosumab displayed positive impact and significant improvements in all sarcopenia measures, and enhanced multidirectional agility with consequent reduction in falls risk. • Denosumab can be considered as a first osteoporosis therapeutic option in this group of patients presenting with osteosarcopenia manifestations.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Biomarker, Retrospective data, Journal: Prognostic Factors in Lung Adenocarcinoma with Bone Metastasis Treated with EGFR-TKIs. (Pubmed Central) - Sep 29, 2021
Those patients that took afatinib as first-line EGFR-TKIs had significantly longer PFS than those treated with other TKIs. Denosumab had no prognostic effect on PFS or OS.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Changes in peripheral monocyte populations 48-72 hours after subcutaneous denosumab administration in women with osteoporosis. (Pubmed Central) - Sep 29, 2021
Our results provide evidence supporting the hypothesis that denosumab administration modifies the monocyte mediated immune response in a manner similar to that of bisphosphonates. This may partly explain the trivial immunity changes recorded with denosumab.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Calcitonin: A useful old friend. (Pubmed Central) - Sep 29, 2021
Therefore, we are posed with an interesting question: is calcitonin a treatment of the past? This review aims to explore the reasons behind this paradigm shift and outline the potential role of calcitonin in the management of fractures and other conditions in the years to come.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer. (Pubmed Central) - Sep 28, 2021
These results in addition to those previously reported for de-escalating zoledronate, would support that de-escalation of commonly used BTAs is a reasonable and economically valid treatment option. While not statistically significant, the increase in subsequent SSEs in the 12-weekly arm requires further exploration.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: A Multi-Institutional Randomized Controlled Trial to Investigate Whether Zoledronate Prevents Bone Loss After Discontinuation of Denosumab: The Study Protocol of Denosumab Sequential Therapy (DST) Trial. (Pubmed Central) - Sep 28, 2021
P4
No other randomized controlled study included all the three different treatment strategies and a positive control. It is also the first associated randomized controlled trial outside Europe.

||||||||||  zamaporvint (RXC004) / Redx
Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  KEYNOTE-E86: A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2) (clinicaltrials.gov) -  Sep 28, 2021
P2, N=40, Not yet recruiting,  Sponsor: Redx Pharma Plc
It is also the first associated randomized controlled trial outside Europe. Trial completion date: Feb 2023 --> Jun 2023 | Initiation date: Jun 2021 --> Sep 2021 | Trial primary completion date: Jul 2022 --> Mar 2023

||||||||||  Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date:  Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis (clinicaltrials.gov) -  Sep 27, 2021
P3, N=24, Active, not recruiting,  Sponsor: Amgen
Trial completion date: Feb 2023 --> Jun 2023 | Initiation date: Jun 2021 --> Sep 2021 | Trial primary completion date: Jul 2022 --> Mar 2023 Trial completion date: May 2029 --> Dec 2023 | Trial primary completion date: May 2026 --> Dec 2023

||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
New P2/3 trial:  Denosumab and Osteoporotic Vertebral Compression Fracture (clinicaltrials.gov) -  Sep 26, 2021
P2/3, N=120, Recruiting,  Sponsor: Shenzhen People's Hospital

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Analysis of the tumor necrosis factor superfamily member 11 gene polymorphism with bone mineral density and bone fracture frequency in patients with postmenopausal osteoporosis. (Pubmed Central) - Sep 26, 2021
Trial completion date: May 2029 --> Dec 2023 | Trial primary completion date: May 2026 --> Dec 2023 Variant rs9533156 may contribute to the genetic regulation of BMD in Polish postmenopausal osteoporosis, while the exon 5 sequence of the TNFSF11 gene is very conservative.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: The Role of Denosumab for Surgical Outcomes in Patients with Giant Cell Tumour of Bone: A Systematic Review. (Pubmed Central) - Sep 26, 2021
There were no reported cases of adverse effects from denosumab. To date, there is insufficient evidence to understand the value of denosumab in the perioperative setting in patients with giant cell tumour of bone.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal, HEOR: Cost-Effectiveness Analysis of 12-Versus 4-Weekly Administration of Bone-Targeted Agents in Patients with Bone Metastases from Breast and Castration-Resistant Prostate Cancer. (Pubmed Central) - Sep 26, 2021
Sensitivity analysis suggests high levels of uncertainty in the cost-effectiveness findings. De-escalation of bone-targeted agents is cost-effective from the Canadian public payer's perspective.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Vascularized Ulnar Transposition and Radioulnoscapholunate Fusion With Volar Locking Plate in a Dorsal Position Following Resection of Giant Cell Tumor of the Distal Radius. (Pubmed Central) - Sep 24, 2021
We present a case of Campanacci Grade III giant cell tumor of the distal radius with pathologic fracture and cortical destruction which was treated with neoadjuvant denosumab...Reconstruction was accomplished using a vascularized ulnar transposition flap to facilitate radioulnoscapholunate fusion, which was fixated using a long-stem contralateral variable angle locking volar distal radius plate in a dorsal position. This case illustrates multidisciplinary management of a challenging reconstructive problem and demonstrates a novel strategy for fixation which repurposes familiar and readily available hardware to provide optimal osteosynthesis.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Treatment of osteoporosis with a modified zeolite shows beneficial effects in an osteoporotic rat model and a human clinical trial. (Pubmed Central) - Sep 23, 2021
To the contrary, long-term use of anti-osteoporotic drugs such as bisphosphonates and Denosumab, an RANKL inhibitor, have resulted in adverse events...Furthermore, patients treated with PMA-zeolite-clinoptilolite showed an increase in bone mineral density, an elevated level of markers indicative of bone formation, a significant reduction in pain, and significantly improved quality of life compared with patients in the control (placebo) group. These encouraging positive effects of PMA-zeolite-clinoptilolite on bone integrity and on osteoporosis warrant further evaluation of treatment with PMA-zeolite-clinoptilolite as a new alternative adjuvant therapy for osteoporosis.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Multiple vertebral fractures after suspension of denosumab. A series of 56 cases. (Pubmed Central) - Sep 23, 2021
After the suspension of denosumab and the production of MVF, there was an increase in the serum values of the BBRM. The time of denosumab use was the only parameter associated with a greater number of fractures.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Same-side insufficiency fractures of the tibia and femur after denosumab discontinuation: A case report. (Pubmed Central) - Sep 22, 2021
However, an increase in the risk of multiple vertebral fractures has been reported after DMAB discontinuation.Case presentation: We described the rare case of a 71-year-old woman with severe OP who experienced same-side insufficiency fractures of the tibia and femur at 18 months after DMAB discontinuation. Careful monitoring for both vertebral and lower limb fragility fractures is advised after DMAB cessation.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Denosumab Safety and Efficacy Among Subjects in the FREEDOM Extension Study With Mild-to-Moderate Chronic Kidney Disease. (Pubmed Central) - Sep 22, 2021
P3
Careful monitoring for both vertebral and lower limb fragility fractures is advised after DMAB cessation. The safety and efficacy of denosumab did not differ among subjects with mild-to- moderate CKD.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / Eisai, AbbVie
Journal, Adverse events: Medication-related osteonecrosis of the jaw -analysing the range of implicated drugs from the Australian Database of Adverse Event Notifications. (Pubmed Central) - Sep 22, 2021
The safety and efficacy of denosumab did not differ among subjects with mild-to- moderate CKD. This study contributes to the sparse but growing literature associating an increasing number of drugs with MRONJ, and underscores the importance of considering all possible drugs that elevate a patient's MRONJ risk.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Osteopathy in mild adrenal Cushing's syndrome and Cushing disease. (Pubmed Central) - Sep 22, 2021
Bone antiresorptive agents (SERMs, bisphosphonates and denosumab) as well as teriparatide increase bone mineral density and in some instances reduce fracture risk. Awareness and management of bone health in CS can be improved.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Denosumab versus zoledronate for the treatment of low bone mineral density in male HIV-infected patients. (Pubmed Central) - Sep 21, 2021
None of our study cohort sustained new fragility fractures during the 12-month study period, and no case of acute phase response was recorded in the ZOL group. In male PLWH under ART requiring osteoporosis treatment both ZOL and Dmab are efficient and well tolerated therapeutic options achieving BMD increases at least for the first year of treatment.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Combined, patient-level, analysis of two randomised trials evaluating the addition of denosumab to standard first-line chemotherapy in advanced NSCLC - The ETOP/EORTC SPLENDOUR and AMGEN-249 trials. (Pubmed Central) - Sep 21, 2021
In male PLWH under ART requiring osteoporosis treatment both ZOL and Dmab are efficient and well tolerated therapeutic options achieving BMD increases at least for the first year of treatment. In this pooled analysis, no statistically significant improvement was shown in PFS/OS with the combination of denosumab and chemotherapy for advanced NSCLC and no meaningful benefit in any of the subgroups.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Treatment initiation with bone-targeting agents among patients with bone metastasis secondary to solid tumors or patients with multiple myeloma. () - Sep 21, 2021 - Abstract #ASCOQC2021ASCO_QC_715;
On average, BTA initiation occurred within about 3 to 4 months from first diagnosis. The proportion of commercial and Medicare patients with SREs prior to BTA initiation was a third and a quarter, respectively.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
[VIRTUAL] Underestimation of the Fracture Risk by the FRAX Formula in Chronic Glucocorticoid Users: A 10-year Longitudinal Validation Study () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_1395;
Despite adjustment for prednisolone dosage, the FRAX formula underestimates the major clinical fracture risk in patients using long-term GCs. The deleterious effect of GCs on bone quality, high proportion of SLE patients, disease activity and use of additional doses of GCs and other immunosuppressive drugs during follow-up are among the contributing factors for this underestimation.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
[VIRTUAL] Clinical Characteristics, Including History of Myocardial Infarction and Stroke, Among US PMO Women Initiating Treatment with Romosozumab and Other Anti-osteoporosis Therapies (Room 6) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_13;
Patients who initiated romo were a high OP-risk population and generally had more comorbidities including CV risk factors. Nevertheless, the low proportion of patients who had a MI/stroke within 1-yr prior to treatment initiation suggests the label boxed warning language may have had the intended effect on patient selection.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
[VIRTUAL] Safety and Efficacy of Denosumab vs Risedronate in Patients with Glucocorticoid-Induced Osteoporosis and Rheumatoid Arthritis (Room 6) - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_12;
Compared with RIS, treatment with DMAb showed significantly larger gains in BMD in patients with GiOP and RA receiving GC treatment. The overall safety profile was similar for both treatments.

||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date:  Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients (clinicaltrials.gov) -  Sep 21, 2021
P2, N=90, Recruiting,  Sponsor: Shinshu University
The overall safety profile was similar for both treatments. Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2022 --> Nov 2024

||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date:  Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy (clinicaltrials.gov) -  Sep 21, 2021
P2, N=90, Recruiting,  Sponsor: Shinshu University
Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2022 --> Nov 2024 Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2022 --> Oct 2023

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal, HEOR: An Updated Systematic Review of Cost-Effectiveness Analyses of Drugs for Osteoporosis. (Pubmed Central) - Sep 19, 2021
In comparison with a previous review, recent economic evaluations of anti-osteoporosis drugs were conducted in more countries and included more active drugs and sequential therapy as interventions/comparators. The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Observational data, Journal: The effect of denosumab on pedicle screw fixation: a prospective 2-year longitudinal study using finite element analysis. (Pubmed Central) - Sep 19, 2021
The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis. To our knowledge, this is the first study to reveal that denosumab treatment achieved strong pedicle screw fixation with an increase in BMD around the screw assessed by QCT and FEA; therefore, denosumab could be useful for osteoporosis treatment during spinal surgery in elderly patients with osteoporosis.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Switching from zoledronic acid to denosumab increases the risk for developing medication-related osteonecrosis of the jaw in patients with bone metastases. (Pubmed Central) - Sep 19, 2021
To our knowledge, this is the first study to reveal that denosumab treatment achieved strong pedicle screw fixation with an increase in BMD around the screw assessed by QCT and FEA; therefore, denosumab could be useful for osteoporosis treatment during spinal surgery in elderly patients with osteoporosis. Our results suggest that switching from ZA to denosumab significantly increases the risk for developing MRONJ in patients with bone metastases.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, Checkpoint inhibition: Does denosumab offer survival benefits? -Our experience with denosumab in metastatic non-small cell lung cancer patients treated with immune-checkpoint inhibitors. (Pubmed Central) - Sep 18, 2021
Patients receiving combination therapy did not perform poorly comparing to published studies despite of poor prognostic features such as brain metastases and numerous skeletal metastases. Although we did notice potential benefit of the longer duration of concomitant use of ICI and denosumab, future prospective clinical trials are needed to evaluate the synergistic effect of RANKL inhibitors/ICI and if duration of RANKL inhibitors matters.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Bone Nanomechanical Properties and Relationship to Bone Turnover and Architecture in Patients With Atypical Femur Fractures: A Prospective Nested Case-Control Study. (Pubmed Central) - Sep 18, 2021
Although we did notice potential benefit of the longer duration of concomitant use of ICI and denosumab, future prospective clinical trials are needed to evaluate the synergistic effect of RANKL inhibitors/ICI and if duration of RANKL inhibitors matters. Atypical femur fractures (AFFs) are well-established serious complication of long-term bisphosphonate and denosumab therapy in patients with osteopenia or osteoporosis..

||||||||||  CT-P41 (denosumab biosimilar) / Celltrion
Enrollment closed, Trial completion date, Trial primary completion date:  A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) -  Sep 17, 2021
P3, N=440, Active, not recruiting,  Sponsor: Celltrion
Atypical femur fractures (AFFs) are well-established serious complication of long-term bisphosphonate and denosumab therapy in patients with osteopenia or osteoporosis.. Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Mar 2023 | Trial primary completion date: Feb 2023 --> Sep 2022

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Hypophosphatasia in Adults: Clinical Spectrum and Its Association With Genetics and Metabolic Substrates. (Pubmed Central) - Sep 17, 2021
Patients with biallelic mutations had more severe symptoms, significantly lower ALP and higher substrate levels. Whether the latter finding has implications for the classification and treatment of HPP should be investigated further in larger cohorts.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: The optimized drug delivery systems of treating cancer bone metastatic osteolysis with nanomaterials. (Pubmed Central) - Sep 17, 2021
Systemic administration of bisphosphonates (BP) or denosumab is the routine therapy for osteolysis but with non-negligible side effects such as mandibular osteonecrosis and hypocalcemia...These delicately fabricated drug delivery systems with special matrix, structure, morphology, and modification can minimize unexpected toxicity caused by systemic delivery and achieve desired effects through integrating multiple drugs or multiple functions. This review summarized recent studies about optimized drug delivery systems for the treatment of cancer metastatic osteolysis, aimed at giving some inspiration in designing efficient multifunctional drug delivery systems.

||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
Phase classification:  Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (clinicaltrials.gov) -  Sep 16, 2021
P3, N=30, Completed,  Sponsor: Massachusetts General Hospital
This review summarized recent studies about optimized drug delivery systems for the treatment of cancer metastatic osteolysis, aimed at giving some inspiration in designing efficient multifunctional drug delivery systems. Phase classification: P1 --> P3

||||||||||  Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date:  Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant (clinicaltrials.gov) -  Sep 16, 2021
P2, N=150, Recruiting,  Sponsor: Roswell Park Cancer Institute
Phase classification: P1 --> P3 Trial completion date: Dec 2022 --> Aug 2023 | Trial primary completion date: Dec 2021 --> Aug 2022

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Osteoclasts recycle via osteomorphs during RANKL-stimulated bone resorption. (Pubmed Central) - Sep 16, 2021
Furthermore, genetic variation in human orthologs of osteomorph genes causes monogenic skeletal disorders and associates with bone mineral density, a polygenetic skeletal trait. Thus, osteoclasts recycle via osteomorphs, a cell type involved in the regulation of bone resorption that may be targeted for the treatment of skeletal diseases.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Antiresorptive treatment and talar collapse after displaced fractures of the talar neck: a long-term follow-up of 19 patients. (Pubmed Central) - Sep 16, 2021
Among these, 6 patients with Hawkins type 3 fractures and 2 patients with Hawkins type 2b fractures received postoperative antiresorptive treatment (7 alendronate, 1 denosumab) for 6 to 12 months...The self-reported foot and ankle score (SEFAS) was available in all patients and 15 patients had undergone computed tomography (CT) at final follow-up, which allowed evaluation of structural collapse of the talar dome and signs of post-traumatic osteoarthritis.Results - The risk for partial collapse of the talar dome was equal in the 2 groups (3 in each group) and post-traumatic arthritis was observed in all patients. The SEFAS in patients with antiresorptive treatment was lower, at 21 points (95% CI 15-26), compared with those without treatment, 29 points (CI 22-35).Interpretation - Following a displaced fracture of the talar neck, we found no effect of antiresorptive therapy on the rate of talar collapse, post-traumatic osteoarthritis, and patient-reported outcomes.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Diagnosis and Management of Osteoporosis During COVID-19: Systematic Review and Practical Guidance. (Pubmed Central) - Sep 16, 2021
We focus on the issues surrounding initiation and maintenance of treatment for patients on parenteral therapies such as zoledronate, denosumab, teriparatide, and romosozumab during the pandemic. The design of these innovative care pathways for the management of patients with osteoporosis may also provide a platform for future improvement to osteoporosis services when routine clinical care resumes.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, HEOR: A pharmacoeconomic evaluation of pharmaceutical treatment options for prostate cancer. (Pubmed Central) - Sep 16, 2021
Docetaxel addition seems to be a cost-effective option, when compared to both abiraterone and enzalutamide (due to costs related to acquisition and side effects). Cabazitaxel is a strong candidate after docetaxel failure, while both denosumab and bisphosphonates are cost-effective for reducing skeletal-related events in metastatic disease.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: The Trend in the Sales of Menopausal Hormone and Other Osteoporosis Medications in South Korea from 2016 to 2019. (Pubmed Central) - Sep 15, 2021
While the sales of TSEC, injectable bisphosphonates, and denosumab have increased annually, the sales of EPT, estrogen therapy, oral bisphosphonates have not increased, as reflected in hormone therapy and osteoporosis medication market trends. This study showed the recent trends in hormone therapy and the osteoporosis medication market from 2016 to 2019 in South Korea.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Review, Journal, HEOR: Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation. (Pubmed Central) - Sep 15, 2021
This study showed the recent trends in hormone therapy and the osteoporosis medication market from 2016 to 2019 in South Korea. Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000-30,000 per quality-adjusted life-year.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Keytruda (pembrolizumab) / Merck (MSD)
Clinical, Review, Journal, Combination therapy: Osteonecrosis of the jaw in a metastatic lung cancer patient with bone metastases undergoing pembrolizumab + denosumab combination therapy: Case report and literature review. (Pubmed Central) - Sep 15, 2021
The combination therapy of ICIs + denosumab has shown promising efficacy and no unexpected safety issues in metastatic melanoma and lung cancer patients with bone metastases. We present a rare case of advanced mandibular osteonecrosis in an adult female with metastatic lung cancer and bone metastases who received concomitant pembrolizumab + denosumab.

|||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Biomarker, Journal: Bone Metastasis: Mechanisms, Therapies and Biomarkers. (Pubmed Central) - Sep 15, 2021
We also describe the progress and future directions of existing bone-targeted agents and report emerging therapies that have arisen from recent advances in our understanding of the pathophysiology of bone metastases. Finally, we discuss the value of bone turnover biomarkers in detection and monitoring of progression and therapeutic effects in patients with bone metastasis.



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