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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
Trial primary completion date: Denosumab Treatment for Fibrous Dysplasia (clinicaltrials.gov) - Dec 22, 2019
P2, N=14, Enrolling by invitation, Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Trial primary completion date: Mar 2030 --> Mar 2026
- ||| Prolia (denosumab) / Amgen
Enrollment open: Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant (clinicaltrials.gov) - Dec 22, 2019
P2, N=180, Recruiting, Sponsor: Roswell Park Cancer Institute
Trial primary completion date: Mar 2030 --> Mar 2026 Not yet recruiting --> Recruiting
- Xofigo (radium Ra-223 dichloride) / Bayer
Radium-223 in the treatment of metastatic castrate-resistant prostate cancer: A real-world Irish experience. (Poster Board B6) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_1090;
Good performance status, lower alkaline phosphatase, chemotherapy naivety and a low burden of metastatic disease are factors associated with an improved overall survival. Research Funding: None.
- Xofigo (radium Ra-223 dichloride) / Bayer
Radium-223 in the treatment of metastatic castrate-resistant prostate cancer: A real-world Irish experience. (Poster Board B6) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_808;
Good performance status, lower alkaline phosphatase, chemotherapy naivety and a low burden of metastatic disease are factors associated with an improved overall survival. Research Funding: None.
- Systemic therapy for nonmetastatic castrate-resistant prostate cancer (M0 CRPC): A systematic review and network meta-analysis (NMA). (Poster Board E15) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_576;
Compared to DARO, APA and ENZA’s demonstrated efficacy is not at the expense of added toxicity. Research Funding: None
- Xofigo (radium Ra-223 dichloride) / Bayer
Fracture rates in radium223 (Ra223) treated mCRPC patients (pts): A real-world analysis in 177 pts treated at a single community center 2010-2018. (Poster Board B7) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_506;
When Ra223 was given concurrently with abi or enza and BHAs, the Fx rate was 6/177 (3.4%). Research Funding: None.
- Zytiga (abiraterone acetate) / J&J
Clinical outcomes of abiraterone acetate + prednisone (AA) + bone resorption inhibitors (BRI) versus AA alone as first-line therapy for castration-resistant prostate cancer (CRPC) with bone metastases (BM) in an international multicenter database. (Poster Board A18) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_495;
The addition of BRI to 1st line AA for CRPC men with BM was associated with improved OS, particularly in HV, and worsened ttSRE, more evident in LV. These data suggest a potentially different impact of concomitant BRI on HV vs. LV, which could affect clinical decision making.
- Systemic therapy for nonmetastatic castrate-resistant prostate cancer (M0 CRPC): A systematic review and network meta-analysis (NMA). (Poster Board E15) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_273;
Compared to DARO, APA and ENZA’s demonstrated efficacy is not at the expense of added toxicity. Research Funding: None
- Xofigo (radium Ra-223 dichloride) / Bayer
Fracture rates in radium223 (Ra223) treated mCRPC patients (pts): A real-world analysis in 177 pts treated at a single community center 2010-2018. (Poster Board B7) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_203;
When Ra223 was given concurrently with abi or enza and BHAs, the Fx rate was 6/177 (3.4%). Research Funding: None.
- Zytiga (abiraterone acetate) / J&J
Clinical outcomes of abiraterone acetate + prednisone (AA) + bone resorption inhibitors (BRI) versus AA alone as first-line therapy for castration-resistant prostate cancer (CRPC) with bone metastases (BM) in an international multicenter database. (Poster Board A18) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_192;
The addition of BRI to 1st line AA for CRPC men with BM was associated with improved OS, particularly in HV, and worsened ttSRE, more evident in LV. These data suggest a potentially different impact of concomitant BRI on HV vs. LV, which could affect clinical decision making.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Intra-articular ectopic ossification associated with denosumab administration for giant cell tumor of bone with intra-articular pathological fracture. (Pubmed Central) - Dec 21, 2019
These data suggest a potentially different impact of concomitant BRI on HV vs. LV, which could affect clinical decision making. No abstract available
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Denosumab versus bisphosphonates for the treatment of bone metastases from solid tumors: a systematic review. (Pubmed Central) - Dec 21, 2019
Denosumab had unfavorable cost-effectiveness compared with zoledronic acid in most of the included studies. New economic studies based on real-world data and longer time horizons comparing these therapeutic options are needed.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Alendronate after denosumab discontinuation in women previously exposed to bisphosphonates was not effective in preventing the risk of spontaneous multiple vertebral fractures: two case reports. (Pubmed Central) - Dec 21, 2019
In both situations, the increased fracture risk may have favoured these new fractures. It is urgent to define effective therapeutic strategies to avoid spontaneous vertebral fractures after denosumab discontinuation.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Physiological concentrations of denosumab enhance osteogenic differentiation in human mesenchymal stem cells of the jaw bone. (Pubmed Central) - Dec 20, 2019
Our evaluations suggest receptor and dose depending effects of denosumab in MSCs. High concentrations mediate toxic effects, whereas physiological and medium concentrations enhance osteogenic differentiation.
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical: GeparX Trial: Neoadjuvant denosumab had no impact on pCR. #SABCS19 https://t.co/93Gv3N4uPO (Twitter) - Dec 20, 2019
- || Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, zoledronic acid / Generic mfg.
Retrospective data, Review, Journal: De-escalation of bone-modifying agents in patients with bone metastases from breast cancer: a systematic review and meta-analysis. (Pubmed Central) - Dec 20, 2019
High concentrations mediate toxic effects, whereas physiological and medium concentrations enhance osteogenic differentiation. These data are supportive of de-escalation of zoledronate from onset for patients with bone metastases from breast cancer.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Antiresorptive Agents and Anti-Angiogenesis Drugs in the Development of Osteonecrosis of the Jaw. (Pubmed Central) - Dec 20, 2019
This hypothesis could be of immediate translational interest. Targeting the anti-angiogenetic effect of the antiresorptive agents could provide a new possibility for the prevention of treatment of MRONJ.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: MRONJ unrelated to bisphosphonates and denosumab. (Pubmed Central) - Dec 20, 2019
Targeting the anti-angiogenetic effect of the antiresorptive agents could provide a new possibility for the prevention of treatment of MRONJ. No abstract available
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Expression Profiling of Receptor-Activator of Nuclear Factor-Kappa B Ligand in Soft Tissue Tumors. (Pubmed Central) - Dec 20, 2019
RANKL-positive cells were detected in GCTTS, PVNS, myositis ossificans, heterotopic calcification, and calcifying aponeurotic fibroma. In conclusion, RANKL is expressed in subsets of soft tissue tumors with calcification, and denosumab is a potential therapeutic option for soft tissue tumors expressing RANKL.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Preoperative Denosumab plus Surgery in the Management of Giant Cell Tumor of Bone: A Comprehensive Narrative Literature Review. (Pubmed Central) - Dec 20, 2019
Furthermore, more than ten cases of denosumab-related malignant transformation of GCTB have been reported in literature. Lastly, large-sized phase III randomized clinical trials with long-term follow-up data are warranted to withdraw concrete conclusions and recommendations.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New trial: Circulating Myokine Levels and Bone Metabolism (clinicaltrials.gov) - Dec 19, 2019
P, N=220, Recruiting, Sponsor: 424 General Military Hospital
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei, Bonrise (ibandronate sodium) / Elder Pharma
Preclinical, Journal: Gingival fibroblasts and medication-related osteonecrosis of the jaw: Results by real-time and wound healing in vitro assays. (Pubmed Central) - Dec 19, 2019
There was no evidence of anti-angiogenic effects. Our experiments present the first results of denosumab with HGFs.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Analysis of three-dimensional bone mineral density and bone strength measured by quantitative computed tomography following denosumab discontinuation in a patient with postmenopausal osteoporosis. (Pubmed Central) - Dec 19, 2019
Our case highlights the increased risk of fractures after discontinuation of denosumab. Therefore, denosumab must be used judiciously without interruption in the dosage schedule.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Antiresorptive drug-related changes of the mandibular bone densitiy in medication-related osteonecrosis of the jaw patients. (Pubmed Central) - Dec 19, 2019
This process may be distinctive for bp-treatment and seems to induce the congestion of cancellous bone rather rapidly after the first administrations. This effect could not be determined in denosumab-treated patients.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New P3 trial: Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients Denosumab in der Vorbeugung des immobilisations-bedignten Knochenabbaus intensivpflichtiger Patienten (EUDRACT) - Dec 19, 2019
P3, N=66, Ongoing, Sponsor: Medical University of Vienna
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Sutent (sunitinib) / Pfizer
Clinical, Journal: Denosumab and Sunitinib in the treatment of giant-cell tumor of bone with pulmonary and bone metastases in an adolescent: A case report. (Pubmed Central) - Dec 19, 2019
This effect could not be determined in denosumab-treated patients. This is a case of multi-center giant cell tumor of bone, it does not only provide a reference to the treatment of similar cases of the clinic but also reflects the limitations of the application of Denosumab in the real world.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Effect of denosumab, a human monoclonal antibody of receptor activator of nuclear factor kappa-B ligand (RANKL), upon glycemic and metabolic parameters: Effect of denosumab on glycemic parameters. (Pubmed Central) - Dec 19, 2019
These data demonstrated that denosumab is useful for T2DM patients with osteoporosis for glycemic control via improvement of insulin resistance. Also, the effect of denosumab might be due to improvement of hepatic function.
- Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, prednisone / Generic mfg.
Bone Health Screening and Treatment in Allogeneic Hematopoietic Stem Cell Transplant (HCT) Patients (World Center Marriott - Grand: Salon 8A) - Dec 18, 2019 - Abstract #TCTASTCTCIBMTR2020TCT_830;
We provide an example of a systematic multidisciplinary approach to assess, prevent and manage bone loss in allogeneic HCT recipients. Study of patient tolerance and prevention of bone density loss in this high risk patient population with this algorithm compared to past practices is ongoing.
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Well done @ANZUPtrials and @DrCraigGedye for advancing this important study in denosumab. Look forward to seeing the study completed. #Cancer (Twitter) - Dec 17, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
this is one situation where prior auth is justified for Denosumab in myeloma pt without CKD (Twitter) - Dec 17, 2019
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
But what about a PFS benefit? #MRCIX showed PFS benefit, but only for the first 4 mos. with Zometa vs Clodronate. In #AMG162 Denosumab improved PFS vs Zometa only in a subgroup and only assessed locally. #MultipleTesting @kaufman_MMdoc #mmsm (Twitter) - Dec 17, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Karma, for liking @EagleMyeloma post about, Zometa vs denosumab, clearly could have used a bone stabilizer, one hand typing for a while (Twitter) - Dec 14, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Real-World Evidence: Of note not many folks are aware of what happens upon rapid discontinuation of xgeva (which likely happens often in real world) (Twitter) - Dec 14, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
This is an urgent question; rebound activation of osteoclast after stopping Xgeva? Already we know stoping Xgeva causes more hypercalcemia. How FDA will address that? It seems we should have follow up data from Xgeva vs. Zometa trial! @VincentRK @FDAOncology @IMFjimMYELOMA (Twitter) - Dec 14, 2019
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Thankfully, I sat next to @MorieGertz during session so I did not falsely believe that #denosumab was superior to #zoledronic acid. https://t.co/E2hDB6Gz0D (Twitter) - Dec 14, 2019
- Faculty (Room 11) - Dec 14, 2019 - Abstract #ENDO2020ENDO_738;
Zoledronate: Zoledronate is usually given at intervals of 1-2 years...Anabolics (teriparatide, abaloparatide, romosozumab): BMD gains during treatment are lost in the months following cessation...In patients having had treatment for >5 years, prevention of rebound bone loss appears to be more difficult, so more intensive bisphosphonate therapy may be required with close monitoring of bone resorption markers and BMD. Patients starting denosumab should be told of this phenomenon so they know that they must not delay injections or discontinue them without transition to a bisphosphonate.
- Faculty (Room 10) - Dec 14, 2019 - Abstract #ENDO2020ENDO_719;
Zoledronate: Zoledronate is usually given at intervals of 1-2 years...Anabolics (teriparatide, abaloparatide, romosozumab): BMD gains during treatment are lost in the months following cessation...In patients having had treatment for >5 years, prevention of rebound bone loss appears to be more difficult, so more intensive bisphosphonate therapy may be required with close monitoring of bone resorption markers and BMD. Patients starting denosumab should be told of this phenomenon so they know that they must not delay injections or discontinue them without transition to a bisphosphonate.
- Tymlos (abaloparatide) / Radius, Teijin, Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
Pharmacological Management of Fracture Risk in the Elderly (Room 207) - Dec 14, 2019 - Abstract #ENDO2020ENDO_384;
Bone density is also improved with zoledronic acid in very frail women and fractures are reduced by zoledronic acid in those with osteopenia. In summary, there are data to support treatment of healthy seniors and more data are being collected to determine if fractures are reduced in frail older adults.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Decadron (dexamethasone) / Merck (MSD)
Journal: Denosumab-induced hypocalcaemia in metastatic castrate-resistant prostate cancer. (Pubmed Central) - Dec 13, 2019
Serum calcium and vitamin D concentrations must be replete prior to administration of denosumab to reduce the risk of hypocalcaemia. Denosumab has been proven to be more effective than zoledronic acid in preventing skeletal-related adverse effects in patients with metastatic castrate-resistant prostate cancer.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Zometa still comes to the rescue post Xgeva...why switch? Stick with what works. (Twitter) - Dec 13, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical: I guess lot of clinicians attend dinners and meetings where other clinicians speaking for drug company are telling them to prescribe denosumab .who is to blame ? Clinicians or the companies ? (Twitter) - Dec 13, 2019
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Zolendronate to Xgeva price ratio for us here is 1:60 (Twitter) - Dec 13, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
HEOR: Other issue worth noting is no renal monitoring for denosumab. Not saying it's necessarily better from a cost-effectiveness perspective - just pointing to possible explanations for current preferences. (Twitter) - Dec 13, 2019
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Doctors in India ordinarily prefer Zoledronic Acid over Denosumab (Twitter) - Dec 13, 2019
- ||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
HEOR, Head-to-Head: ...This study was non-inferiority study. Both positive studies have HR of 0.80, offering about a 20%reduction and a few months delay in SRE. But at what cost to the system? Denosumab has been shown not to be cost-effective relative to ZA. (Twitter) - Dec 13, 2019
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Retrospective data: The study you cited mostly had solid tumor patients. The meta-analysis was from 3 trials, 1 trail each in breast cancer and castrate resistant prostate cancer where (denosumab was superior), the third trial was in a bunch of solid tumors most of whom were lung cancer... (Twitter) - Dec 13, 2019
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Pricing: Use of Denosumab (Xgeva) in myeloma patients from 2017-2019 is now 40% of the bone modifying agent market in #myeloma. WTF! Cost is invisible to most clinicians -- wouldn't you pay attention if dinner cost $1,700 versus $17? #mmsm https://t.co/eHshEaax5g (Twitter) - Dec 13, 2019
- ||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical: See how even in patients without renal impairment, denosumab has captured ~20% share of market. @JAMAOnc (Twitter) - Dec 13, 2019
- |||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Denosumab is >20 times more expensive that zoledronic acid— but not superior. Our system encourages use of 𝙢𝙤𝙧𝙚 expensive drug: Within 15 months ~40% market share. Study led by @guptaarjun90 @MartyMakary @HopkinsMedicine @oncology_bg @JAMAOnc https://t.co/uDDLrIxeM9 #CostVR (Twitter) - Dec 13, 2019
- || Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
I haven’t been able to read the full article yet, but I would expect at least some of the uptake is driven by the RCT investigators’ message that denosumab improves PFS over zoledronate. This was a hypothesis-generating finding and should not be used to base treatment decisions. (Twitter) - Dec 13, 2019