- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial initiation date, Trial primary completion date: PREFERRED-1: PRevEnting FracturEs in REnal Disease 1 (clinicaltrials.gov) - May 5, 2022
P4, N=60, Not yet recruiting,
PhA appears to be a clinically significant indicator of improvement of Δfemur in patients receiving denosumab. Trial completion date: Sep 2023 --> Dec 2023 | Initiation date: Jan 2022 --> May 2022 | Trial primary completion date: Apr 2023 --> Dec 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Application of osteoinductive calcium phosphate ceramics in giant cell tumor of the sacrum: report of six cases. (Pubmed Central) - Apr 29, 2022
Six patients (four females and two males, 25-45 years old) underwent nerve-sparing surgery, in which the tumor was treated by denosumab, preoperative arterial embolization and extensive curettage...In conclusion, osteoinductive CaP bioceramics could be an ideal biomaterial to treat the large remaining cavity following extensive curettage of sacral GCT. However, further investigation with more cases and longer follow-up was required to confirm the final clinical effect.
- |||||||||| Review, Journal, PD(L)-1 Biomarker: Kutane Angiosarkome: molekulare Pathogenese und neue therapeutische Ansätze. (Pubmed Central) - Apr 28, 2022
Dazu gehören zielgerichtete Therapien gegen VEGF und VEGFR1-3 wie Bevacizumab und Pazopanib, sowie β-Adrenozeptorenblocker wie Propranolol. Derzeit werden auch Immuntherapien entwickelt, unter anderem unter Verwendung der Immuncheckpoint-Inhibitoren Pembrolizumab und Nivolumab sowie des Anti-RANKL-Antikörper Denosumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Bone-targeting agent utilization among lung cancer patients with bone metastasis in Taiwan. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6383;
A large population of patients with lung cancer were diagnosed with BM every year. However, overall, we observed only a small proportion of eligible patients receiving a BTA and a delayed initiation of BTA, indicating suboptimal treatment for lung cancer patients with BM in Taiwan.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Keytruda (pembrolizumab) / Merck (MSD)
Therapeutic effects and clinical outcomes of immune checkpoint inhibitors on bone metastases in lung cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2957;
ICI treatment showed favorable responses to bone metastases in NSCLC and better prognoses than conventional predictive prognosis. Particularly, pembrolizumab may be the most effective, and the therapeutic effect was enhanced by the concomitant use of denosumab.Abbreviations: RECIST 1.1 response evaluation criteria in solid tumors 1.1, MDA criteria MD Anderson criteria, CR complete response, PR partial response, SD stable disease, PD progressive disease
- |||||||||| RXC004 / Redx, Opdivo (nivolumab) / Ono Pharma, BMS
A multi-arm, phase 2, open-label study to assess the efficacy of RXC004 as monotherapy and in combination with nivolumab in patients with ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, metastatic, microsatellite stable colorectal cancer following standard treatments. (Available On Demand; 426b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1437;
P1, P2
For Arm B, a TV of 30% ORR is considered clinically significant against a LRV of 10% ORR (Eng, 2019). RXC004 is also being investigated in a second Phase 2 trial, PORCUPINE 2 (NCT04907851), in Biliary Tract Cancers and RNF-43 mutated Pancreatic Cancers.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Safety and efficacy of bone-modifying agents among multiple myeloma patients: A retrospective cohort study. (Pubmed Central) - Apr 27, 2022
Multiple myeloma patients receiving chemotherapy without a bone-modifying agent had higher rates of skeletal-related events compared to those being treated with chemotherapy and a bonemodifying agent. Our results highlight the benefit of utilizing bonemodifying agents for the prevention of skeletal-related events in all multiple myeloma patients being treated with chemotherapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Medication-related osteonecrosis of the jaw in a patient with multiple myeloma: an unusual case with tumor in the surgical specimen. (Pubmed Central) - Apr 26, 2022
Medication-related osteonecrosis of the jaw (MRONJ) is a well-known complication of treatment with bisphosphonates, denosumab, and other drugs, such as anti-angiogenic agents and novel anti-cancer drugs...Before 2 years, she received chemotherapy of zoledronate for multiple myeloma at another hospital...Finally, the surgical specimen was diagnosed as multiple myeloma in the sequestrum. This case suggests that the evaluation of the surgical specimen of MRONJ could be essential for detection of primary tumor.
- |||||||||| Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Cutaneous Angiosarcomas: Molecular Pathogenesis Guides Novel Therapeutic Approaches. (Pubmed Central) - Apr 26, 2022
Nevertheless, beyond conventional surgery and chemoradiotherapy, clinical trials investigating novel treatment options have been initiated including targeted therapies against VEGF and VEGFR1-3 such as bevacizumab and pazopanib, and β-adrenoreceptor blockers such as propranolol. Finally, immunotherapies are being developed including immune checkpoint inhibitors pembrolizumab and nivolumab as well as anti-RANKL antibody denosumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Anti-RANKL Inhibits Thymic Function and Causes DRONJ in Mice. (Pubmed Central) - Apr 26, 2022
Denosumab, a human monoclonal antibody against receptor activator of nuclear factor-kappa B ligand (RANKL), is a novel bone antiresorptive agent used in patients with osteoporosis or metastatic bone cancer...Anti-mouse RANKL monoclonal antibody and melphalan were performed to create a mouse model of DRONJ-like lesions in female C57BL/6J mice...This study suggests evidence of an immunity-based mechanism of DRONJ-like disease. This work may contribute to a better understanding of the pathogenesis of human DRONJ.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Premenopausal osteoporosis. (Pubmed Central) - Apr 22, 2022
The safety of bone-specific therapy, especially long term and during pregnancy, remains uncertain. Bisphosphonates, teriparatide, denosumab and estrogen treatment increase bone density in premenopausal women with osteoporosis, but there are no study data confirming short-term fracture prevention with use of these agents.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Medical treatment of osteoporosis. (Pubmed Central) - Apr 22, 2022
In high-risk patients, anabolic agents may be considered as an initial therapeutic option. The combination of antiresorptive and anabolic agents may be useful to increase BMD compared with monotherapy, but more information is warranted to determine the effects on fracture risk.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Breast cancer therapy and bone. (Pubmed Central) - Apr 22, 2022
Currently, evidence supports the use of the bisphosphonates, zoledronic acid and clodronate, in this setting. Unfortunately, a focus on bone health in women with breast cancer is often not prioritized, leaving this group vulnerable to significant bone loss and subsequent fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Osteoporosis in men. (Pubmed Central) - Apr 22, 2022
Bisphosphonates, denosumab, and teriparatide have been shown to increase BMD and are used for pharmacological treatment. In this Review, we report an updated overview of osteoporosis in men, describe new treatments and concepts, and discuss persistent controversies in the area.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: HDENO: Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease (clinicaltrials.gov) - Apr 21, 2022
P4, N=4, Terminated,
The importance of indirectly comparing available osteoporosis treatments using time point-specific NMAs was confirmed because indirect comparison results differed substantially across time points. N=30 --> 4 | Trial completion date: May 2023 --> Dec 2021 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Dec 2021; Modified study and new deposit in RECHMPL21_0451
- |||||||||| PROLONGED SURVIVAL WITH CHECK-POINT INHIBITOR /TYROSINE KINASE INHIBITOR FOR RELAPSED OSTEOSARCOMA () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_347;
After each relapse she got local control, when possible, and received different salvage regimens: denosumab, gemcitabine/docetaxel/bevacizumab/zoledronic acid, combination NIV/samarium respectively, until the last relapse when we introduced NIVO-LEN and tapered off gemcitabine and zoledronic acid.To date the patient has had 30 cycles of NIVO-LEN with her longest progression free interval (28 months),minimal toxicity and excellent QoL.Patient 2 is a 15 year old male, diagnosed with localized OST at 12 years old with surgery (60% necrosis) and conventional chemotherapy of MAP, who relapsed twice post therapy in bone (15 months), sacrum (4 months later). Our preliminary data will inform our colleagues about the possible potential for immune-chemotherapy such as CPI and TKI combinations, for these difficult to treat patients with few options.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Mepact (mifamurtide) / Takeda, Votrient (pazopanib) / Novartis
B-HCG AS A TUMOR MARKER IN OSTEOSACROMA: A CASE REPORT () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_86;
She subsequently received cyclophosphamide, etoposide, and carfilzomab without improvement and -HCG levels continued to rise. B-HCG may be a sensitive marker to guide treatment choices in some cases of osteosarcoma.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: "Pregnancy and Lactation Associated Osteoporosis". (Pubmed Central) - Apr 20, 2022
Management of PAO is challenging, due both to a poor evidence base and the fact that spontaneous improvement in BMD is known to occur once pregnancy and lactation are complete. Bisphosphonates, denosumab and teriparatide have all been used in individual patients, but the data supporting their use are currently limited.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Metastatic giant cell tumour of bone: a narrative review of management options and approaches. (Pubmed Central) - Apr 20, 2022
Combined denosumab and bisphosphonate therapy has the potential to achieve sustained disease control or remission in unresectable metGCTB without requiring long-term treatment and should be evaluated in prospective trials. Various novel agents have demonstrated in vitro and anecdotal efficacy and warrant further evaluation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Occult Renal Calcifications in Patients with Normocalcemic Primary Hyperparathyroidism and Their Association with the Parathyroid Hormone-Vitamin D Axis. (Pubmed Central) - Apr 20, 2022
The diagnosis of NPHPT was as follows: elevated serum PTH (reference range: 15-65 pg/mL), normal albumin-corrected serum calcium, normal urinary calcium excretion, serum 25(OH)D >30 ng/mL, eGFR (CKD-EPI) > 60 mL/min/1.73 m, without intestinal disease, and not on medications such as thiazide diuretics, lithium, bisphosphonates, or denosumab...Conclusion. Occult renal calcifications are common in NPHPT and are associated with increased serum PTH, 1.25(OH))D, and 24 h urinary calcium.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Short or long-term osteoporosis therapy with denosumab ? (Pubmed Central) - Apr 19, 2022
Occult renal calcifications are common in NPHPT and are associated with increased serum PTH, 1.25(OH))D, and 24 h urinary calcium. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Snyder-Robinson syndrome: differential diagnosis of osteogenesis imperfecta. (Pubmed Central) - Apr 19, 2022
The patient was treated with bisphosphonates for a decade, until developing an atypical femoral fracture. Teriparatide was then administered for 2 years and then changed to denosumab every 6 months, improving his bone density mass and preventing further fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Denosumab After Teriparatide in Premenopausal Women with Idiopathic Osteoporosis. (Pubmed Central) - Apr 19, 2022
Teriparatide was then administered for 2 years and then changed to denosumab every 6 months, improving his bone density mass and preventing further fractures. These data support the use of sequential teriparatide and denosumab to increase BMD in premenopausal women with severe osteoporosis.
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