- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Medication-related osteonecrosis of the jaw: Prosthodontic considerations. (Pubmed Central) - Jan 6, 2022
Medication-related osteonecrosis of the jaw (MRONJ) can be triggered by several antiresorptive and antiangiogenic medications, including bisphosphonates (BRONJ), denosumab (DRONJ), and other agents used to treat osteoporosis and metastatic bone cancer...Denture trauma has been reported to be a risk factor for MRONJ, and few reports have discussed the prosthodontic considerations needed for patients with this condition. The aim of this review is to highlight the prosthodontic considerations that would decrease the risk of triggering MRONJ in susceptible patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Use of bone modifying agents for metastatic castrate-resistant prostate cancer. (In-Person & On Demand | Level 1, West Hall) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_287;
In most cases BMA therapy was initiated while patients still had castrate-sensitive disease, for which BMAs are indicated only at lower doses for the prevention of osteoporotic fractures. Further work is needed to understand whether real-world dosing is in line with clinical indications, and whether the one-third of patients who did not receive BMA therapy appropriately reflects the proportion of patients with contraindications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Real-world treatment patterns among patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. (In-Person & On Demand | Level 1, West Hall - B12) - Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_281;
With rapidly evolving treatment options in metastatic prostate cancer, these data can help guide estimation of eligible patients for different clinical trials. Further studies are needed to understand the high attrition from 1L to subsequent lines of therapy, the reasons for treatment preference and impact on clinical outcomes with different treatment sequencings.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Denosumab-induced osteonecrosis of external auditory canal. (Pubmed Central) - Jan 5, 2022
No major complications or recurrence were observed in the left ear after surgery, but bone erosion in the right ear has continued to progress slowly despite the cessation of denosumab administration. Otolaryngologists should be aware of the association between osteonecrosis of external auditory canal and denosumab administration and consider performing long-term observation even after cessation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Grossing and reporting of bone tumor specimens in surgical oncology: Rationale with current evidence and recent updates. (Pubmed Central) - Jan 5, 2022
This review focuses upon the types of biopsies, grossing techniques of various specimens in orthopedic oncology and reporting, with rationale and recommendations from pathologists, actively involved in reporting and pursuing a special interest in bone tumors, based on current evidence. Furthermore, there is a section on some of the updates in the diagnosis of bone tumors, based on the recent fifth edition of the World Health Organization classification of tumors of soft tissues and bone.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Giant Cell Tumor of Bone: An Update. (Pubmed Central) - Jan 4, 2022
The elucidation of the pathophysiology of giant cell tumor of bone, especially with regards to the role of nuclear factor kappa B ligand (RANKL), has led to the Food and Drug Administration (FDA) approval of denosumab in the management of locally advanced or metastatic GCTB. For advanced giant cell tumor where surgical resection alone can cause severe morbidity, the paradigm has shifted from local treatment alone to multidisciplinary management with the consideration of use of denosumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Adherence to bone health guidelines in patients with hormone receptor-positive early breast cancer: Status and clinical impact in a Swiss cohort experience. (Pubmed Central) - Jan 4, 2022
Alongside calcium and vitamin D3 supplementation, bisphosphonates and denosumab are well-known options for improving outcomes in bone health and breast cancer prognosis...The most frequent tumor characteristics were tumor size of pT1-pT2 (N = 53, 77.9%) and treatment with letrozole (N = 35, 51.5%), followed by tamoxifen as a switch strategy (N = 27, 40.3%)...The adherence to bone health guidelines was satisfactory but still suboptimal. Clinicians should strictly adhere to the current bone health guidelines to ensure the best possible prevention of BREs and maintain bone health and cancer prognosis in patients with ER + eBC.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab Treatment for Giant Cell Tumors, Aneurysmal Bone Cysts, and Fibrous Dysplasia-Risks and Benefits. (Pubmed Central) - Jan 1, 2022
However, its clinical use is impacted by ongoing safety concerns related to postdiscontinuation rebound, particularly in children. There is a critical need to understand denosumab treatment and discontinuation effects on tumor recurrence and to develop strategies for long-term treatment in patients who cannot be managed surgically.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Prognosis of Medication-Related Osteonecrosis of the Jaws in Metastatic Prostate Cancer Patients. (Pubmed Central) - Dec 28, 2021
In conclusion, pharmaceutical interventions according to our management system benefit safe denosumab treatment, especially in severe hypocalcemia prevention. A higher pretreatment level of CTX, using denosumab as the antiresorptive agent and without anemia, indicates a better treatment outcome of MRONJ in prostate cancer patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: State of the Art and New Concepts in Giant Cell Tumor of Bone: Imaging Features and Tumor Characteristics. (Pubmed Central) - Dec 27, 2021
Radiomics has proved to offer a valuable contribution in aiding GCTB pre-operative diagnosis through clinical-radiomics models based on CT scans and multiparametric MR imaging, possibly guiding the choice of a patient-tailored treatment. Moreover, radiomics models based on texture analysis demonstrated to be a promising alternative solution for the assessment of GCTB response to denosumab both on conventional radiography and CT since the quantitative variation of some radiomics features after therapy has been correlated with tumor response, suggesting they might facilitate disease monitoring during post-denosumab surveillance.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Bone Diseases and Supportive Care. (Pubmed Central) - Dec 25, 2021
Moreover, radiomics models based on texture analysis demonstrated to be a promising alternative solution for the assessment of GCTB response to denosumab both on conventional radiography and CT since the quantitative variation of some radiomics features after therapy has been correlated with tumor response, suggesting they might facilitate disease monitoring during post-denosumab surveillance. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Reimbursement, Journal, Medicare: Patterns of teriparatide and sequential antiresorptive agent treatment among elderly female Medicare beneficiaries. (Pubmed Central) - Dec 25, 2021
Among switchers, 42.5% switched within 60 days, 50.5% switched to denosumab, and 31.6% switched to oral bisphosphonates...Persistence of teriparatide use was suboptimal. In the management of postmenopausal osteoporosis, increasing the persistence of teriparatide use and improving the appropriate treatment sequence of anabolic and antiresorptive drugs are critical to maximizing gains in bone mass, providing the greatest protection against fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone metastases from urothelial carcinoma. The dark side of the moon. (Pubmed Central) - Dec 24, 2021
For these patients, multidisciplinary approach should be preferred, involving orthopaedics, radiotherapists and rehabilitation to improve outcome and quality of life. New prospective trials should characterize clinical and molecular features of patients with bone metastases and the impact of new drugs on this poor prognostic metastatic site.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Therapeutics for enhancement of spinal fusion: A mini review. (Pubmed Central) - Dec 24, 2021
In terms of systemic therapeutic approaches, the osteoporosis drug Teriparatide has played a positive role in promoting bone healing after spinal surgery, while new medications such as denosumab and sclerostin antibodies still need further validation...With the accumulation of higher-level evidence, the safety and efficacy of present and emerging products are becoming more evident. These emerging therapeutics will shift the landscape of perioperative therapy for the enhancement of spinal fusion.
- |||||||||| zamaporvint (RXC004) / Redx
Enrollment open, Trial initiation date, Monotherapy: PORCUPINE: A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) (clinicaltrials.gov) - Dec 23, 2021
P2, N=50, Recruiting,
As better baseline T-score predicted achievement of T-scores > -2.5, early initiation of treatment will contribute to better outcome. Not yet recruiting --> Recruiting | Initiation date: Aug 2021 --> Nov 2021
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Giant cell tumor of bone (Pubmed Central) - Dec 23, 2021
Better knowledge of the role of RANK-L in the pathophysiology of these tumors has led to clinical trials involving denosumab. Treatment with denosumab is suggested for inoperable lesions, or for aggressive lesions, in particular of the spine, pelvis, and sacrum before en bloc resection.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Therapies for Preventing Bone Loss with Glucocorticoid Treatment. (Pubmed Central) - Dec 18, 2021
With due consideration to cost, resource availability, and patient values and preferences, these agents may warrant use as the first-line agents in this setting. Glucocorticoid-induced osteoporosis remains preventable and warrants early and targeted evidence-based therapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Type 2 Diabetes Mellitus and Vertebral Fracture Risk. (Pubmed Central) - Dec 18, 2021
Results from two recent studies show that both teriparatide and denosumab are effective in reducing vertebral fracture risk also in individuals with T2DM. Individuals with T2DM could benefit from systematic screening in the clinic for presence of vertebral fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Intralesional nerve-sparing surgery versus non-surgical treatment for giant cell tumor of the sacrum. (Pubmed Central) - Dec 18, 2021
Non-surgical treatment has a similar risk of complications to intralesional nerve-sparing surgery and has better functional outcomes than intralesional nerve-sparing surgery, but patients must remain on therapy over time. Based on our results, the decision on the choice of treatment for sacral giant cell tumors could be discussed between the surgeon and the patient based on the tumor size and location.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Combination therapy: Different Perspectives of Drug Holiday and Combination Therapies When Treating Osteoporosis (Pubmed Central) - Dec 18, 2021
The only exception is the sequence of TPTD after denosumab (Dmab), which leads to a loss (transient) of BMD in both the lumbar spine and the hip; for this reason, this sequence should be avoided at all costs...An effect of osteoanabolic therapy with TPTD on BMD of the hip is expected only in combination with antiresorptive therapy (bisphosphonates, Dmab). If the antiresorptive therapy is not continued, there is a transient loss in the first months of osteoanabolic monotherapy, the more so the stronger the antiresorptive pretreatment was.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed: A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis (clinicaltrials.gov) - Dec 17, 2021
P3, N=326, Active, not recruiting,
If the antiresorptive therapy is not continued, there is a transient loss in the first months of osteoanabolic monotherapy, the more so the stronger the antiresorptive pretreatment was. Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Postmenopausal osteoporosis: risk evaluation and treatment options. (Pubmed Central) - Dec 16, 2021
From the literature it emerges that menopausal hormone therapy (MHT), TSEC combination and SERMs can be drugs of choice to counteract postmenopausal bone loss in younger women or at low risk of fracture, while bisphosphonates and denosumab are appropriate for women with high risk or at an older age. Therapy with denosumab and anabolic agents such as teriparatide and romosozumab is particularly indicated for subjects with very high risk of fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Denosumab and Lichen Planus: Two cases. (Pubmed Central) - Dec 16, 2021
A 4mm punch biopsy was taken from the right groin. Histopathological analysis showed a perivascular and interstitial infiltrate of lymphocytes and scattered histiocytes in the upper dermis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Dental pathologies in tumor patients with bone metastases or multiple myeloma scheduled for antiresorptive therapy. (Pubmed Central) - Dec 16, 2021
In 76 patients (63.9%), a dental focus was revealed including deep caries (24.4% of patients), chronic apical periodontitis (26.9%), periodontal disease (45.8%), root remnants (16%), jaw cysts (2.5%), partially impacted teeth (5.0%) and peri-implantitis (5.0%). Considering the high number of dentoalveolar pathologies (63.9%), systematic dental focus screening prior to initiation of antiresorptive therapy is of utmost importance to lower the risk for MRONJ.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Primary Hyperparathyroidism Masquerading as Acute Pancreatitis. (Pubmed Central) - Dec 16, 2021
One patient had refractory hypercalcemia associated with renal failure and was successfully managed with denosumab...PHPT masquerading as acute pancreatitis is rare and high index of suspicion is required to diagnose this condition especially in the presence of normocalcemia at presentation. Patients with PHPT associated pancreatitis had male preponderance, higher calcium levels, and lower frequency of skeletal involvement as compared to PHPT patients without pancreatitis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: A single-center experience with giant cell tumors of sphenoid bone and clivus. (Pubmed Central) - Dec 16, 2021
There are no defined guidelines for the treatment of GCTs in skull base. Following surgical resection of the tumor, the addition of denosumab treatments to radiotherapy has a significant role in preventing the recurrence of GCT and in promoting regression of residual tumor size.
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