- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Symplastic/pseudoanaplastic giant cell tumor of the bone. (Pubmed Central) - Mar 23, 2018 GCTB with symplastic/pseudoanaplastic change is an uncommon variant of conventional GCTB, which can mimic primary sarcoma or sarcomatous transformation. These tumors possess the same missense mutation in histone H3.3 as conventional GCTB.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Phase classification, Trial completion date, Trial primary completion date: Denosumab Administration After Spinal Cord Injury (clinicaltrials.gov) - Mar 12, 2018 P4, N=24, Recruiting, These tumors possess the same missense mutation in histone H3.3 as conventional GCTB. Phase classification: P2 --> P4 | Trial completion date: May 2018 --> May 2019 | Trial primary completion date: May 2017 --> May 2019
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial initiation date, Trial primary completion date: DOHA: Denosumab Versus Zoledronic Acid in Thalassemia-Induced Osteoporosis (clinicaltrials.gov) - Mar 8, 2018 P3, N=20, Not yet recruiting, Trial completion date: Jan 2023 --> Apr 2023 | Trial primary completion date: Jan 2023 --> Apr 2023 Trial completion date: Apr 2018 --> Jul 2019 | Initiation date: Sep 2017 --> May 2018 | Trial primary completion date: Jan 2018 --> May 2019
- |||||||||| Prolia (denosumab) / Amgen
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: DenosuMast: Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis (clinicaltrials.gov) - Mar 8, 2018 P3, N=90, Recruiting, Trial completion date: Apr 2018 --> Jul 2019 | Initiation date: Sep 2017 --> May 2018 | Trial primary completion date: Jan 2018 --> May 2019 Not yet recruiting --> Recruiting | Trial completion date: Jan 2023 --> Mar 2023 | Initiation date: Jan 2018 --> Mar 2018 | Trial primary completion date: Jan 2021 --> Mar 2021
- |||||||||| Prolia (denosumab) / Amgen, Kineret (anakinra) / SOBI
Enrollment closed, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases: NCI-2018-01842: Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers (clinicaltrials.gov) - Mar 7, 2018 P1, N=57, Active, not recruiting, Not yet recruiting --> Recruiting | Trial completion date: Jan 2023 --> Mar 2023 | Initiation date: Jan 2018 --> Mar 2018 | Trial primary completion date: Jan 2021 --> Mar 2021 Recruiting --> Active, not recruiting | N=147 --> 57 | Trial completion date: Jun 2019 --> Jun 2021 | Initiation date: Jun 2012 --> Jun 2012 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial initiation date: Observational Study of Denosumab (Prolia (clinicaltrials.gov) - Jan 30, 2018 P=N/A, N=1501, Completed, Trial primary completion date: Mar 2018 --> Sep 2018 Initiation date: Nov 2012 --> Nov 2011
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial primary completion date: TNFSF11 Inhibition and Fertility: a Prospective Study (clinicaltrials.gov) - Jan 29, 2018 P2, N=15, Active, not recruiting, Initiation date: Nov 2012 --> Nov 2011 Trial primary completion date: Feb 2016 --> Feb 2017
- |||||||||| Prolia (denosumab) / Amgen, Xofigo (radium Ra-223 dichloride) / Bayer
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: Trial of Ra-223 Dichloride in Combination With Hormonal Therapy and Denosumab in the Treatment of Patients With Hormone-Positive Bone-Dominant Metastatic Breast Cancer (clinicaltrials.gov) - Jan 26, 2018 P2, N=45, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=36 --> 45 | Trial primary completion date: Feb 2019 --> Feb 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed, Enrollment change: Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement (clinicaltrials.gov) - Jan 9, 2018 P4, N=6, Active, not recruiting, This large population-based cohort study shows that denosumab and zoledronic acid have comparable clinical safety and effectiveness with regard to the risk of serious infection, CVD and osteoporosis fracture within 365 days after initiation of medications. Recruiting --> Active, not recruiting | N=15 --> 6
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Phase classification: Osteoclast Inhibition and Bone Formation (clinicaltrials.gov) - Jan 5, 2018 P1, N=81, Completed, Recruiting --> Active, not recruiting | N=15 --> 6 Phase classification: P=N/A --> P1
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Biomarker, Enrollment closed, Enrollment change: Denosumab for Breast Cancer With Bone Mets (clinicaltrials.gov) - Jan 3, 2018 P2, N=7, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=35 --> 7
- |||||||||| Prolia (denosumab) / Amgen
Enrollment change, Trial termination, Trial primary completion date, IO biomarker: D-Beyond: A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer (clinicaltrials.gov) - Dec 29, 2017 P2, N=27, Terminated, Recruiting --> Active, not recruiting | N=35 --> 7 N=39 --> 27 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2016 --> Dec 2017; Poor recruitment
- |||||||||| Tymlos (abaloparatide) / Radius, Teijin, Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Clinical, Journal, HEOR: A Model for Assessing the Clinical and Economic Benefits of Bone-Forming Agents for Reducing Fractures in Postmenopausal Women at High, Near-Term Risk of Osteoporotic Fracture. (Pubmed Central) - Dec 27, 2017 Incorporating time-specific fracture effects in the Markov cohort model allowed for estimation of a range of cost savings, quality-adjusted life years gained, and clinical fractures avoided at different levels of fracture protection onset and magnitude. Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial primary completion date: Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis (clinicaltrials.gov) - Dec 22, 2017 P=N/A, N=20, Enrolling by invitation, Results provide a first estimate of the potential "value" new bone-forming agents (romosozumab and abaloparatide) may confer relative to teriparatide. Trial primary completion date: Dec 2018 --> Dec 2020
- |||||||||| Prolia (denosumab) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment open, Trial primary completion date, Checkpoint inhibition: CHARLI: Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Dec 18, 2017 P1/2, N=72, Recruiting, Trial primary completion date: Dec 2018 --> Dec 2020 Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021 | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021 | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial primary completion date, Metastases: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer (clinicaltrials.gov) - Dec 15, 2017 P3, N=129, Active, not recruiting, Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021 | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021 | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2019 --> Jun 2021 Trial primary completion date: Dec 2017 --> Mar 2018
- |||||||||| Prolia (denosumab) / Amgen
Trial primary completion date: Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) - Dec 7, 2017 P=N/A, N=575462, Active, not recruiting, Additional information is available at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki . Trial primary completion date: May 2023 --> May 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial primary completion date: Study of Denosumab in Subjects With Giant Cell Tumor of Bone (clinicaltrials.gov) - Nov 27, 2017 P2, N=536, Active, not recruiting, Trial primary completion date: May 2023 --> May 2020 Trial primary completion date: Nov 2017 --> May 2018
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