FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2258935908> ?p ?o ?g. }

• W2258935908 endingPage "iv540" @default.
• W2258935908 startingPage "iv540" @default.
• W2258935908 abstract "ABSTRACT Background: Denosumab is a monoclonal antibody against RANK-Ligand with a higher activity in preventing skeletal related events (SREs) than zoledronic acid but without impact on disease progression or death. SREs are pathologic bone fractures, surgery or radiation to the bone or spinal cord compression. The relative effects on SREs in patients with bone metastases from castration resistant prostate cancer and breast cancer are similar (hazard ratio 0.82). Denosumab is usually well tolerated but a dose-dependent increase in risk of osteonecrosis of the jaw in up to 8% of patients and cases of fatal hypocalcaemia have been observed. The approved dose of denosumab is 120mg sc every 4 weeks (q4w); the basis for this dose and schedule, however, is not quite clear. E.g. in a study of 255 women with bone metastases from breast cancer who were randomized to receive denosumab 30mg q4w, 120 mg q4w, 180 mg q4w, 60mg q12w, 180mg q12w or an iv bisphosphonate, a similar degree of creatinine-corrected urinary N-telopeptide (uNTx/Cr) suppression was observed at weeks 13 and 25 in all cohorts. Given that the optimal dose and schedule of denosumab is unknown and this drug is associated with considerable costs and adds toxicity a study of de-escalation is warranted. Trial design: The aim of this trial is to test the hypothesis that the benefit of denosumab is maintained if administered 120mg q12w as compared to 120mg q4w. The primary endpoint of this randomized phase III non-inferiority trial is time to first on-trial symptomatic skeletal event (SSE) defined as clinically significant pathological fracture, surgery to bone, radiation therapy to bone, or spinal cord compression. With a non-inferiority margin of 1.2 for the hazard ratio, a power 80% and a type I error 5%, the total sample size is 1380. Secondary endpoints include safety, time to first and subsequent on-trial SSE, health economic outcomes, quality of life, and change in bone turnover markers. Patients with adequate organ function and bone metastases from breast cancer of from castration resistant prostate cancer are eligible. This trial is open for international collaboration. ClinicalTrials.gov identifier: NCT02051218. Reused with permission from the American Society of Clinical Oncology (ASCO). This abstract was accepted and previously presented at the 2014 ASCO Annual Meeting. All rights reserved. Disclosure: S. Gillessen: Advisory board Novartis; B. Thurlimann: Stock owndership Novartis: R. von Moos: Research funding, honoraria, and consultant Amgen. Honoraria and advisory board Novartis. All other authors have declared no conflicts of interest." @default.
• W2258935908 created "2016-06-24" @default.
• W2258935908 creator A5025804381 @default.
• W2258935908 creator A5047212102 @default.
• W2258935908 creator A5047242761 @default.
• W2258935908 creator A5048283327 @default.
• W2258935908 creator A5061473697 @default.
• W2258935908 creator A5063187447 @default.
• W2258935908 creator A5075265048 @default.
• W2258935908 creator A5082338484 @default.
• W2258935908 creator A5083491572 @default.
• W2258935908 creator A5086220270 @default.
• W2258935908 creator A5091264312 @default.
• W2258935908 date "2014-09-01" @default.
• W2258935908 modified "2023-09-26" @default.
• W2258935908 title "Prevention of Symptomatic Skeletal Events with Denosumab Administered Every 4 Weeks Versus Every 12 Weeks–A Non-Inferiority Phase III Trial: Sakk 96/12 - Reduse" @default.
• W2258935908 doi "https://doi.org/10.1093/annonc/mdu356.71" @default.
• W2258935908 hasPublicationYear "2014" @default.
• W2258935908 type Work @default.
• W2258935908 sameAs 2258935908 @default.
• W2258935908 citedByCount "3" @default.
• W2258935908 countsByYear W22589359082015 @default.
• W2258935908 countsByYear W22589359082022 @default.
• W2258935908 crossrefType "journal-article" @default.
• W2258935908 hasAuthorship W2258935908A5025804381 @default.
• W2258935908 hasAuthorship W2258935908A5047212102 @default.
• W2258935908 hasAuthorship W2258935908A5047242761 @default.
• W2258935908 hasAuthorship W2258935908A5048283327 @default.
• W2258935908 hasAuthorship W2258935908A5061473697 @default.
• W2258935908 hasAuthorship W2258935908A5063187447 @default.
• W2258935908 hasAuthorship W2258935908A5075265048 @default.
• W2258935908 hasAuthorship W2258935908A5082338484 @default.
• W2258935908 hasAuthorship W2258935908A5083491572 @default.
• W2258935908 hasAuthorship W2258935908A5086220270 @default.
• W2258935908 hasAuthorship W2258935908A5091264312 @default.
• W2258935908 hasBestOaLocation W22589359081 @default.
• W2258935908 hasConcept C121608353 @default.
• W2258935908 hasConcept C126322002 @default.
• W2258935908 hasConcept C126894567 @default.
• W2258935908 hasConcept C141071460 @default.
• W2258935908 hasConcept C143998085 @default.
• W2258935908 hasConcept C168563851 @default.
• W2258935908 hasConcept C203092338 @default.
• W2258935908 hasConcept C207103383 @default.
• W2258935908 hasConcept C2776286101 @default.
• W2258935908 hasConcept C2776326535 @default.
• W2258935908 hasConcept C2776541429 @default.
• W2258935908 hasConcept C2777251235 @default.
• W2258935908 hasConcept C44249647 @default.
• W2258935908 hasConcept C530470458 @default.
• W2258935908 hasConcept C71924100 @default.
• W2258935908 hasConceptScore W2258935908C121608353 @default.
• W2258935908 hasConceptScore W2258935908C126322002 @default.
• W2258935908 hasConceptScore W2258935908C126894567 @default.
• W2258935908 hasConceptScore W2258935908C141071460 @default.
• W2258935908 hasConceptScore W2258935908C143998085 @default.
• W2258935908 hasConceptScore W2258935908C168563851 @default.
• W2258935908 hasConceptScore W2258935908C203092338 @default.
• W2258935908 hasConceptScore W2258935908C207103383 @default.
• W2258935908 hasConceptScore W2258935908C2776286101 @default.
• W2258935908 hasConceptScore W2258935908C2776326535 @default.
• W2258935908 hasConceptScore W2258935908C2776541429 @default.
• W2258935908 hasConceptScore W2258935908C2777251235 @default.
• W2258935908 hasConceptScore W2258935908C44249647 @default.
• W2258935908 hasConceptScore W2258935908C530470458 @default.
• W2258935908 hasConceptScore W2258935908C71924100 @default.
• W2258935908 hasLocation W22589359081 @default.
• W2258935908 hasOpenAccess W2258935908 @default.
• W2258935908 hasPrimaryLocation W22589359081 @default.
• W2258935908 hasRelatedWork W1985888545 @default.
• W2258935908 hasRelatedWork W2025069729 @default.
• W2258935908 hasRelatedWork W2066699153 @default.
• W2258935908 hasRelatedWork W2104203487 @default.
• W2258935908 hasRelatedWork W2122786185 @default.
• W2258935908 hasRelatedWork W2141378241 @default.
• W2258935908 hasRelatedWork W2282079980 @default.
• W2258935908 hasRelatedWork W2398182636 @default.
• W2258935908 hasRelatedWork W2464598453 @default.
• W2258935908 hasRelatedWork W2591299183 @default.
• W2258935908 hasRelatedWork W2958818878 @default.
• W2258935908 hasRelatedWork W2965080360 @default.
• W2258935908 hasRelatedWork W2981726330 @default.
• W2258935908 hasRelatedWork W2990876124 @default.
• W2258935908 hasRelatedWork W3000122784 @default.
• W2258935908 hasRelatedWork W3007352892 @default.
• W2258935908 hasRelatedWork W3036796440 @default.
• W2258935908 hasRelatedWork W3089083731 @default.
• W2258935908 hasRelatedWork W3173723023 @default.
• W2258935908 hasRelatedWork W3176176740 @default.
• W2258935908 hasVolume "25" @default.
• W2258935908 isParatext "false" @default.
• W2258935908 isRetracted "false" @default.
• W2258935908 magId "2258935908" @default.
• W2258935908 workType "article" @default.