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110 Diseases |  |
151 Trials |
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151 Trials |  |
7120 News |  |
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- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. (Pubmed Central) - Aug 14, 2021
It is uncertain whether anti-osteoporotic drug improves the BMD at the femoral neck because the certainty of this evidence is very low. Larger studies including men, paediatric patients or individuals with unstable CKD-mineral and bone disorder are required to assess the effect of each anti-osteoporotic drug at each stage of CKD.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal, HEOR: Patients' quality of life improves after surgical intervention of stage III medication-related osteonecrosis of the jaw. (Pubmed Central) - Aug 13, 2021
In terms of QoL patients with stage III MRONJ do benefit from surgical treatment. The incident of a recurrence seems to have no significant impact on patients QoL.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
That's kind of strange because denosumab costs 20 times more than the other two. That would have been an easy call for me. But it's listed first. It looks like two groups could not agree with zoledronic acid should be given every 12 weeks or every 3-4 weeks so they put in both. (Twitter) - Aug 12, 2021
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Updates in epidemiology, pathophysiology and management strategies of glucocorticoid-induced osteoporosis. (Pubmed Central) - Aug 11, 2021
Moreover, there are no specific indications for the management of bone fragility in endogenous hypercortisolism. Notwithstanding the above limitations there is a general consensus to recommend an assessment of fracture risk in all individuals >40 years committed to receive (or continuing) high dose (>7.5 mg of prednisone equivalent) GCs for ≥3 months and in all patients with fragility fracture history.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Role of (Neo)adjuvant Denosumab for Giant Cell Tumor of Bone. (Pubmed Central) - Aug 11, 2021
In all cases, multidisciplinary discussion with oncology, pathologist, radiologist, and surgeons is mandatory. Patient's comorbidities, dental conditions, and preferences, including family planning, should always be taken into account.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Cardiovascular Safety of Denosumab Across Multiple Indications. (Pubmed Central) - Aug 11, 2021
Patient's comorbidities, dental conditions, and preferences, including family planning, should always be taken into account. No abstract available
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Efficacy of Zoledronic Acid in Maintaining Areal and Volumetric Bone Density after Combined Denosumab and Teriparatide Administration: DATA-HD Study Extension. (Pubmed Central) - Aug 11, 2021
Spine BMD was also largely, though not fully, maintained during this period. These data suggest that the DATA-HD Extension regimen may be an effective strategy in the long-term management of patients at high risk of fragility fracture.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Treatment with zoledronate subsequent to denosumab in osteoporosis: a 2-year randomized study. (Pubmed Central) - Aug 11, 2021
P4
These data suggest that the DATA-HD Extension regimen may be an effective strategy in the long-term management of patients at high risk of fragility fracture. Treatment with ZOL subsequent to long-term denosumab, did not fully prevent increased bone turnover and bone loss during the first year, however, CTX remained with the reference range and BMD was maintained during the second year.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Bisphosphonates after Denosumab withdrawal reduce the vertebral fractures incidence. (Pubmed Central) - Aug 11, 2021
The Dmab withdrawal is associated with an increased risk of clinical but not morphometric VFx. Therapy with ALN or with a single ZOL treatment are partially effective in reducing the increased VFx risk after Dmab withdrawal.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Current strategies for the treatment of solitary and aneurysmal bone cysts: A review of the literature. (Pubmed Central) - Aug 10, 2021
With cytogenetic studies and the detection of specific translocations of the ubiquitin-specific protease (USP) 6 gene primary ABCs can be differentiated from secondary ABCs and other bone lesions. Among various modalities of treatment i.e. en bloc resection, intralesional curettage with adjuvants, embolization or the systemic application of denosumab, intralesional sclerotherapy using polidocanol is an effective and minimally invasive treatment of primary ABCs.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: The role of bone-modifying agents in myeloma bone disease. (Pubmed Central) - Aug 10, 2021
Among various modalities of treatment i.e. en bloc resection, intralesional curettage with adjuvants, embolization or the systemic application of denosumab, intralesional sclerotherapy using polidocanol is an effective and minimally invasive treatment of primary ABCs. The mainstay of MBD prevention are antiresorptive agents, bisphosphonates and denosumab..
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Knowledge and Needs of Resident Physicians Regarding Osteoporosis: A Nationwide Survey of Residents. (Pubmed Central) - Aug 10, 2021
The mainstay of MBD prevention are antiresorptive agents, bisphosphonates and denosumab.. Fifteen percent of respondents correctly identified that denosumab and alendronate are associated with osteonecrosis of the jaw; and 40% of respondents correctly identified that decline in bone density is more rapid after discontinuation of denosumab than after discontinuation of bisphosphonates..
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Adverse events: Every day at the office, I see 4 to 6 older women (and some men) who get their Prolia shot for osteoporosis. Some 97 percent of them have been C19 vaccinated. They are in their 70's, 80's and 90's. No problems. No troublesome side effects. All would do it again. All happy. (Twitter) - Aug 10, 2021
- Prolia (denosumab) / Amgen, Daiichi Sankyo
[VIRTUAL] Bone - Targeted Agents Improve Survival in High Bone Tumor Burden Advanced Non - Small - Cell - Lung Cancer Patients Treated With PD - (L)1 Inhibitors (ePoster Hall) - Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_967;
However, in HBTB subgroup BTA significantly improved OS and PFS, making these pts as the best candidates for BTA-ICI concurrent treatment. DN rather than ZA was associated with survival benefit, suggesting a synergy between ICIs and RANK ligand inhibition.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Current Concepts in the Treatment of Giant Cell Tumors of Bone. (Pubmed Central) - Aug 8, 2021
Local recurrence after 2 years or more should be indicative of malignant transformation. This review summarizes the treatment approaches for non-malignant and malignant GCTBs.
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo
q3 month even from beginning for most unless extensive bone disease. Rarely use denosumab but that would be q4wk (Twitter) - Aug 6, 2021
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed, Trial completion date, Trial initiation date, Trial primary completion date: Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients (clinicaltrials.gov) - Aug 5, 2021
P=N/A, N=73, Active, not recruiting, Sponsor: Nigde Omer Halisdemir University
This review summarizes the treatment approaches for non-malignant and malignant GCTBs. Completed --> Active, not recruiting | Trial completion date: Feb 2021 --> Aug 2021 | Initiation date: Jan 2020 --> Jul 2020 | Trial primary completion date: Feb 2021 --> Aug 2021
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Visualization of hidden soft-tissue recurrence of giant cell tumor of bone enabled by preoperative denosumab treatment: a case description. (Pubmed Central) - Aug 4, 2021
Completed --> Active, not recruiting | Trial completion date: Feb 2021 --> Aug 2021 | Initiation date: Jan 2020 --> Jul 2020 | Trial primary completion date: Feb 2021 --> Aug 2021 No abstract available
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Osteosarcopenia: epidemiology, diagnosis, and treatment-facts and numbers. (Pubmed Central) - Aug 4, 2021
It is anticipated that diagnosis and treatment for osteosarcopenia will become part of routine healthcare in the future. However, further work is required to identify biomarkers, which, in turn, may increase diagnosis, risk stratification, and targeted treatments to improve health outcomes.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Treatment of central giant cell granuloma in children with denosumab. (Pubmed Central) - Aug 4, 2021
Here, we describe our experience with the use of denosumab in the treatment of six children with CGCG. All patients had a favorable response with manageable side effects, which suggests that denosumab is an effective treatment option without increased morbidity.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Effect of denosumab switched from bisphosphonates in preventing joint destruction in postmenopausal rheumatoid arthritis patients with anti-cyclic citrullinated peptide antibodies. (Pubmed Central) - Aug 4, 2021
All patients had a favorable response with manageable side effects, which suggests that denosumab is an effective treatment option without increased morbidity. Denosumab treatment might be effective for the inhibition of bone erosion progression in the patients with RA, and it potentially contributes to the treatment of osteoporosis and prevention of destructive arthritis in patients with switching treatment from bisphosphonate.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Inhibition of RANK signaling as a potential immunotherapy in breast cancer. (Pubmed Central) - Aug 4, 2021
RANK signaling in mouse mammary tumor cells exerts an immunosuppressive environment by promoting the infiltration of pro-tumorigenic neutrophils and preventing CD8 T cell recruitment. Single-agent denosumab led to an increased tumor immune infiltration by lymphocytes and CD8 + T cells in breast cancer patients, supporting the immunomodulatory role of RANK signaling.
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Opioids are fast to control pain but high dependence is a issue. Zoledronic acid or denosumab could control pain in middle time. (Twitter) - Aug 2, 2021
- | Prolia (denosumab) / Amgen
Enrollment open: The DENOCHARCOT Trial (clinicaltrials.gov) - Aug 2, 2021
P3, N=38, Recruiting, Sponsor: Ole Lander Svendsen
Single-agent denosumab led to an increased tumor immune infiltration by lymphocytes and CD8 + T cells in breast cancer patients, supporting the immunomodulatory role of RANK signaling. Not yet recruiting --> Recruiting
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical: If pts are on long term dex (relapsed post asct on dara based or down the line), I usually continue q3 monthly xgeva or zometa (Twitter) - Aug 1, 2021
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Association of osteopenia and osteoporosis with higher rates of pseudarthrosis and revision surgery in adult patients undergoing single-level lumbar fusion. (Pubmed Central) - Aug 1, 2021
Postoperative pseudarthrosis and revision surgery rates following single-level lumbar spinal fusion are significantly higher in patients with osteopenia and osteoporosis than in patients with normal BMD. Pretreatment with medications to prevent bone loss prior to surgery decreased these complication rates, although the observed differences did not reach statistical significance.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Clinical and Radiological Characterization of Patients with Immobilizing and Progressive Stress Fractures in Methotrexate Osteopathy. (Pubmed Central) - Jul 31, 2021
Ten patients re-evaluated at follow-up (2.6 ± 1.5 years) had improved clinically in terms of successful remobilization. Taken together, our findings provide the first in-depth skeletal characterization of patients with pathognomonic stress fractures after long-term MTX treatment.
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Totally agree with most SREs happening shortly after Rx initiation. Not surprising given the steep decline in time-to-SRE curves in both Zometa and Xgeva arms of the RCT in 1st 6 months #mmsm (Twitter) - Jul 30, 2021
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition. (Pubmed Central) - Jul 30, 2021
Patients should be strongly encouraged to avoid tobacco, consume alcohol in moderation at most, and engage in regular exercise and fall prevention strategies. Finally, referral to endocrinologists or other osteoporosis specialists may be warranted for individuals who experience repeated fracture or bone loss and those with complicating comorbidities (e.g., hyperparathyroidism, chronic kidney disease).
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: A Pooled Analysis of Fall Incidence From Placebo-controlled Trials of Denosumab. (Pubmed Central) - Jul 30, 2021
In conclusion, denosumab may reduce the risk of falls in addition to its established fracture risk reduction by reducing bone resorption and increasing bone mass. These observations require further exploration and confirmation in studies with muscle function or falls as the primary outcome.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: Cardiovascular safety of denosumab across multiple indications: a systematic review and meta-analysis of randomized trials. (Pubmed Central) - Jul 30, 2021
Future trials should use standardized CAE reporting to better describe cardiovascular effects of bone active medications. (PROSPERO: CRD42019135414.).
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Effects of Combination Denosumab and High-Dose Teriparatide Administration on Bone Microarchitecture and Estimated Strength: the DATA-HD HR-pQCT Study. (Pubmed Central) - Jul 30, 2021
Improvements in trabecular microarchitecture at the distal tibia and estimated strength by micro-finite element analysis at both sites were numerically greater in the HD-group compared to SD-group, but not significantly so. Together, these findings suggest that short-term treatment combining denosumab with either high or standard-dose teriparatide improves HR-pQCT measures of bone density, microstructure, and estimated strength, with greater gains in total bone density observed in the HD-group, which may be of benefit in postmenopausal women with severe osteoporosis.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Predictors of Fracture in Older Women with Osteopenic Hip Bone Mineral Density Treated with Zoledronate. (Pubmed Central) - Jul 30, 2021
Differences in achieved BMD between those who do or do not fracture arise from the close relationship between baseline and achieved BMDs. These findings suggest that targeting any particular BMD during treatment is unlikely to be a useful or valid strategy.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Risk of Incident Atrial Fibrillation With Zoledronic Acid Versus Denosumab: A Propensity Score-Matched Cohort Study. (Pubmed Central) - Jul 30, 2021
These findings suggest that targeting any particular BMD during treatment is unlikely to be a useful or valid strategy. Compared with denosumab, ZA treatment for osteoporosis and possibly for malignancy-related bone disease is associated with modestly increased risk of incident AF in the first year of treatment.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Evaluation of segmental mandibular resection without microvascular reconstruction in patients affected by medication-related osteonecrosis of the jaw: a systematic review. (Pubmed Central) - Jul 30, 2021
More often it has been described in association with bisphosphonates (BP), but nowadays it has been observed with the use of other medications, such as denosumab (a RANK ligand inhibitor and monoclonal antibody agent) and antiangiogenic drugs...The data show a relatively high percentage of recurrence. Additional data based on a larger cohort of patients or case-control studies are necessary to justify routine use of this type of intervention in patients affected by the condition.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Impact of Zoledronic Acid and Denosumab Treatment on Growth Factor Concentration in Platelet Rich Fibrin of Patients With Osteolytic Bone Metastases. (Pubmed Central) - Jul 30, 2021
Reduced EGF levels in PRF after ZA treatment may explain the delayed wound healing and question the positive effect of PRF in these patients. PRF use in patients undergoing RANKL-I treatment seems to be more justified.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Media coverage of drug regulatory agencies' safety advisories: a case study of citalopram and denosumab. (Pubmed Central) - Jul 28, 2021
Citalopram coverage covered harms more often but rarely mentioned cardiac arrhythmias. These findings raise questions about how to better ensure that regulatory risk communications reach the general public.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Biomarker, Retrospective data, Journal: Quantitative Prediction of Bone Mineral Density by Using Bone Turnover Markers in Response to Antiresorptive Agents in Postmenopausal Osteoporosis: A Model-based Meta-analysis. (Pubmed Central) - Jul 28, 2021
This exploratory analysis built a quantitative framework linked BTMs and BMD among antiresorptive agents, as well as a modeling approach to enhance comprehension of dynamic relationship between early and later endpoints among agents in a certain mechanism of action. Moreover, the developed models can offer predictions of BMD from BTMs supporting early drug development.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Associated characteristics and treatment outcomes of medication-related osteonecrosis of the jaw in patients receiving denosumab or zoledronic acid for bone metastases. (Pubmed Central) - Jul 28, 2021
The results of this study suggest that treatment with denosumab, age > 65 years, and tooth extraction before and after starting BMA treatments are significantly associated with developing MRONJ in patients undergoing treatment for bone metastases. However, MRONJ caused by denosumab resolves faster than that caused by zoledronic acid.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, Sutent (sunitinib) / Pfizer
Journal: New Target for Precision Medicine Treatment of Giant-Cell Tumor of Bone: Sunitinib Is Effective in the Treatment of Neoplastic Stromal Cells with Activated PDGFRβ Signaling. (Pubmed Central) - Jul 28, 2021
To summarize, the obtained data showed that a specific receptor tyrosine kinase (RTK) signaling pattern is activated in GCTB cells and plays an important role in the regulation of cell proliferation. Thus, activated RTKs and their downstream signaling pathways represent useful targets for precision treatment with low-molecular-weight inhibitors or with other types of modern biological therapy.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Late Local Recurrence of Bone Giant Cell Tumors Associated with an Increased Risk for Malignant Transformation. (Pubmed Central) - Jul 28, 2021
Overall, 4 patients with primary malignant GCTB, 4 patients with missing data, 3 patients with a history of radiotherapy, 22 patients with a follow-up of less than 6 months, and 36 patients who received denosumab were excluded...The interval between the last surgery to local recurrence and malignant transformation was longer than that to local recurrence of benign GCTB, with a median of 15.2 years (interquartile range [IQR], 5.2-25.4) versus 1.3 months (IQR, 0.8-2.6), respectively (p < 0.001). Late local recurrence of GCTB is associated with a higher risk of malignant transformation.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: The Role of PINP in Diagnosis and Management of Metabolic Bone Disease. (Pubmed Central) - Jul 27, 2021
PINP as well as CTX may also be used in assessing offset of drug action following a pause in bisphosphonate therapy, to help decide when to re-instate therapy, or following cessation of denosumab therapy to assess efficacy of follow-on bisphosphonate therapy...Although BTM other than bone alkaline phosphatase are currently not recommended for use in metabolic bone disease of chronic kidney disease, PINP measured by assays specific to the intact molecule has potential in this condition. Further studies are needed to examine this area, as well as in malignant bone disease.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Letter to the editor concerning "Denosumab Treatment for Giant Cell Tumor of the Spine Including the Sacrum". (Pubmed Central) - Jul 27, 2021
Further studies are needed to examine this area, as well as in malignant bone disease. No abstract available
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical: Osteonecrosis of the jaw among patients with cancer treated with denosumab or zoledronic acid: Results of a regulator‐mandated cohort postauthorization safety study in Denmark, Norway, and Sweden https://t.co/2JvhNl7By0 (Twitter) - Jul 27, 2021
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion, Enrollment change: Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (clinicaltrials.gov) - Jul 26, 2021
P1, N=30, Completed, Sponsor: Massachusetts General Hospital
No abstract available Active, not recruiting --> Completed | N=75 --> 30
- ||||| SB16 (denosumab biosimilar) / Samsung
Enrollment closed: A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia (clinicaltrials.gov) - Jul 26, 2021
P3, N=458, Active, not recruiting, Sponsor: Samsung Bioepis Co., Ltd.
Active, not recruiting --> Completed | N=75 --> 30 Recruiting --> Active, not recruiting
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Real-life use of denosumab 120 mg every 12 weeks in prolonged treatment over 2 years of patients with breast cancer bone metastases. (Pubmed Central) - Jul 24, 2021
Denosumab confirms a good activity profile in terms of delaying and preventing SREs in breast cancer patients and a good safety profile. It represents an optimal treatment resource which doesn't necessitate renal function monitoring and has the convenience of a subcutaneous administration.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Oral risk factors associated with medication-related osteonecrosis of the jaw in patients with cancer. (Pubmed Central) - Jul 24, 2021
Our findings suggest that patients with alveolar bone loss involving more than half the root on panoramic radiographs and torus mandibularis carry a high risk of MRONJ development. Early dental intervention before BMA administration and oral management during the treatment are important for preventing MRONJ.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Antiresorptive agent-related osteonecrosis of the jaw (ARONJ) in urological malignancies: a multi-center retrospective study. (Pubmed Central) - Jul 24, 2021
ARONJ is not a rare adverse event in urological malignancies. Especially, kidney cancer, high BMI patients and who needed tooth extraction before BMA were high risk for developing ARONJ.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Differences in subtrochanteric and diaphyseal atypical femoral fractures in a super-aging prefectural area: YamaCAFe Study. (Pubmed Central) - Jul 24, 2021
This study suggests that the onset of ST AFFs have greater correlation with the worse bone quality, vice versa, the onset of DP AFFs correlated with the bone geometry. The developmental mechanisms of AFFs may differ significantly between ST and DP fractures.