- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: PROUD: Preventing Osteoporosis Using Denosumab (clinicaltrials.gov) - Mar 4, 2020
P4, N=212, Recruiting,
Trial completion date: Dec 2021 --> Sep 2023 | Trial primary completion date: Dec 2021 --> Sep 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Management of Osteogenesis Imperfecta. (Pubmed Central) - Mar 3, 2020
There have been huge advances in understanding the pathogenesis of OI but these have not been accompanied by advances in treatment. This signals need for well-designed clinical trials with fracture endpoints in OI, both with existing agents and with the newer therapeutic agents that are now starting to emerge.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Journal: Bone metastases from lung cancer: a paradigm for multidisciplinary onco-rheumatology management. (Pubmed Central) - Mar 2, 2020
Surgical strategies will be discussed elsewhere. Based on the last 2017-Lung Cancer South East French Guidelines, we present a practical decision tree to help the physicians for decision making in order to reach a personalized locomotor strategy for every patient.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: A Case of atypical Femoral Fracture after Dosing Denosumab (Pubmed Central) - Mar 2, 2020
He was diagnosed with AFF, and denosumab was discontinued. Ourcase suggests that we must considerthe possibility of AFF when pain around the thigh occurs after dosing denosumab.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Expression of H3.3 G34W mutant-specific antibody in giant cell tumors of bone and its diagnostic value (Pubmed Central) - Feb 28, 2020
All recurrent (9/9)/metastatic GCTB (2/2), post-denosumab GCTB (3/3), primary malignant GCTB (3/3) and secondary malignant GCTB (5/5) also expressed H3.3 G34W...The limitation of this antibody is that as a mall number of GCTB harbor G34 mutation other than G34W, and thus that cannot be detected. The incidental expression of H3.3 G34W mutant protein in osteosarcoma could be a potential diagnostic dilemma, and the results of H3.3 G34W IHC staining needs careful interpretation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: What's new in management of bone metastases? (Pubmed Central) - Feb 26, 2020
These include embolization, electrochemotherapy, magnetic resonance imaging-guided high-intensity focused ultrasound, and thermal ablation. Less invasive techniques combine the advantages of less invasive procedures including decreased blood loss, earlier functional recovery and initiation of adjuvant medical therapies and seem to be both effective in pain relief and local tumor control.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Vascularized Ulnar Transposition and Radioulnoscahpolunate Fusion With Volar Locking Plate in a Dorsal Position Following Resection of Giant Cell Tumor of the Distal Radius. (Pubmed Central) - Feb 26, 2020
We present a case of Campanacci Grade III giant cell tumor of the distal radius with pathologic fracture and cortical destruction which was treated with neoadjuvant denosumab...Reconstruction was accomplished using a vascularized ulnar transposition flap to facilitate radioulnoscapholunate fusion, which was fixated using a long-stem contralateral variable angle locking volar distal radius plate in a dorsal position. This case illustrates multidisciplinary management of a challenging reconstructive problem and demonstrates a novel strategy for fixation which repurposes familiar and readily available hardware to provide optimal osteosynthesis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Tamoxis (tamoxifen) / Bioprofarma
Clinical, Journal: Assessment and management of bone health in women with oestrogen receptor-positive breast cancer receiving endocrine therapy: position statement summary. (Pubmed Central) - Feb 24, 2020
Both bisphosphonates and denosumab prevent bone loss; additionally, denosumab has proven anti-fracture benefit in post-menopausal women receiving aromatase inhibitors for hormone receptor-positive breast cancer...Skeletal health should be considered in the decision-making process regarding choice and duration of endocrine therapy. Before and during endocrine therapy, skeletal health should be assessed regularly, optimised by non-pharmacological intervention and, where indicated, anti-resorptive treatment, in an individualised, multidisciplinary approach.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Clinical, Journal: A pragmatic, randomised, multicentre trial comparing 4-weekly vs. 12-weekly administration of bone-targeted agents (denosumab, zoledronate or pamidronate) in patients with bone metastases. (Pubmed Central) - Feb 23, 2020
Before and during endocrine therapy, skeletal health should be assessed regularly, optimised by non-pharmacological intervention and, where indicated, anti-resorptive treatment, in an individualised, multidisciplinary approach. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Denosumab - where does it stand in the GIOP armamentarium? (Pubmed Central) - Feb 22, 2020
Denosumab is a welcome addition in the armamentarium of this disease due to its once-in-six months dosing, which is associated with better adherence than bisphosphonates[2] and its renal safety [3]. However, certain clarifications may further help the readers to understand its applicability and choosing it as an alternative therapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Pseudomyogenic hemangioendothelioma of bone treated with denosumab: a case report. (Pubmed Central) - Feb 21, 2020
However, certain clarifications may further help the readers to understand its applicability and choosing it as an alternative therapy. Denosumab plays a certain role in prevention of bone destruction by PMHE through suppression of osteoclast-like giant cells and would be an excellent treatment for bone absorption by PMHE of bone.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Rebound-Associated Vertebral Fractures After Stopping Denosumab: Report Of Four Cases (HALL 8 HIPPOCRATES) - Feb 20, 2020 - Abstract #ISGE2020ISGE_521;
Moreover, vertebroplasty seems an unsuccessful approach for RAVFs and should be avoided in these patients. There is an urgent need to identify patient groups at risk of RAVFs and to design optimal management protocols for denosumab discontinuation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment open, Surgery, Bariatric surgery: Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery (clinicaltrials.gov) - Feb 20, 2020
P4, N=36, Recruiting,
There is an urgent need to identify patient groups at risk of RAVFs and to design optimal management protocols for denosumab discontinuation. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Actonel (risedronate) / Sanofi, zoledronic acid / Generic mfg., Asahi Kasei
Prior Adherence to HMG Co-A Reductase Inhibitors is a Predictor of Subsequent Adherence and Persistence to Oral, but Not Parenteral, Osteoporosis Medications () - Feb 19, 2020 - Abstract #CRAAHPA2020CRA-AHPA_403;
We included adults over the age of 20 who were new users of an oral bisphosphonate (alendronate and risedronate) and/or parenteral osteoporosis therapies (zoledronic acid, denosumab and teriparatide) from April 1, 2009-March 31, 2018 and had filled at least one statin prescription in the prior 12 months before the start date of the osteoporosis treatment. Prior adherence to HMG Co-A reductase inhibitors is a predictor of subsequent adherence and persistence with oral bisphosphonates but not parenteral therapies used to treat Osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei, Bonrise (ibandronate sodium) / Elder Pharma
Persistence and Adherence to Parenteral Osteoporosis Therapies: A Systematic Review () - Feb 19, 2020 - Abstract #CRAAHPA2020CRA-AHPA_269;
While the data are heterogeneous, included studies suggest superior persistence and adherence with parenteral osteoporosis therapies compared to data for oral bisphosphonates. To maximize adherence and persistence to parenteral therapies, it’s important to consider patient specific determinants
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, cyclophosphamide intravenous / Generic mfg., Rituxan (rituximab) / Roche, Biogen
Atypical Denosumab-Induced Metatarsal Fractures () - Feb 19, 2020 - Abstract #CRAAHPA2020CRA-AHPA_200;
She has been managed with prednisone 5mg po daily for 7 years, hydroxychloroquine, vitamin D, pantoprazole, warfarin, ramipril, and rosuvastatin...Her risk factors for osteoporosis include early menopause at the age of 39, chronic prednisone use, and use of a proton-pump inhibitor, rituximab, cyclophosphamide, and warfarin...Previous case reports had documented atypical metatarsal fractures with bisphosphonates and atypical femoral fractures with denosumab. Thus, clinicians should consider asking patients for symptoms and consider assessing for insufficiency stress fractures, as well as consider discontinuing denosumab if metatarsal fractures are found.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Zytiga (abiraterone acetate) / J&J
Review, Journal: Immune system and bone microenvironment: rationale for targeted cancer therapies. (Pubmed Central) - Feb 19, 2020
Conversely, initial data evidenced a possible anti-bone resorption effect of systemic anticancer drugs through and immunomodulation activity, i.e. new generation antiandrogens (Abiraterone) in prostate cancer. All data could open a future rationale of combined bone, immunologic and targeted therapies in cancer treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Nursing experience in the treatment of a lung adenocarcinoma with distal clavicular metastasis patient (Henry B. Gonzalez Convention Center - Tower View Registration) - Feb 17, 2020 - Abstract #ONS2020ONS_427;
Systemic chemotherapy; palliative radiation therapy (total dose of 30Gy in 10 fractions) was administered with denosumab for bone metastasis...【Conclusions】 This case presents with an extremely rare occurrence of clavicular metastasis from primary lung adenocarcinoma foretelling an unfortune short-term median-survival. However, under multidisciplinary management, the pain can be effectively alleviated and quality of life can be significantly improved with a favorable prognosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Denosumab(XGEVA), an alternative to hemipelvectomy in the treatment of massive bone metastasis (Henry B. Gonzalez Convention Center - Tower View Registration) - Feb 17, 2020 - Abstract #ONS2020ONS_343;
【Conclusions】 Denosumab could be an alternative treatment option for patients with inoperable massive and destructive bone metastasis. Appropriate nursing plan focusing on diet education, caring plan for specific joints, and prevention of adverse events would help achieve a better clinical outcome.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Comparison of Risk of Osteoporotic Fracture in Denosumab vs Alendronate Treatment Within 3 Years of Initiation. (Pubmed Central) - Feb 16, 2020
The aHR for any fracture for denosumab vs alendronate was 0.84 (95% CI, 0.71-0.98) among patients with a history of any fracture and 0.77 (95% CI, 0.64-0.93) among patients with no history of fracture. Treatment with denosumab and alendronate was associated with similar risks of hip or any fracture over a 3-year period, regardless of fracture history.
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Histone deacetylases: Expression and function in liver fibrosis and hepatic stellate cells () - Feb 15, 2020 - Abstract #PLCECNT2020PLC_ECNT_51;
Viability and proliferation of activated HSC is reduced by the treat- ment with different HDACi. Our findings indicate the potential of HDAC inhibition as anti- fibrogenic therapeutic strategy in chronic liver disease.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Fracture risk following intermission of osteoporosis therapy. (Pubmed Central) - Feb 14, 2020
Different pharmacokinetic properties for different therapies require different strategies to manage drug intermission. In contrast, long-term treatment with anti-resorptives is not associated with increased risk of fragility fractures and skeletal adverse events remain rare.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Use of anti-osteoporosis medication dispensing by patients with hip fracture: could we do better? (Pubmed Central) - Feb 14, 2020
Less than one-third of hip fracture patients had dispensing of anti-osteoporosis medication up to 1 year after hip fracture. We observed only a slight increase in dispensing after hip fracture over the study period, irrespective of patient sex, age, and comorbidity at the time of hip fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Review, Journal: From Osteoclast Differentiation to Osteonecrosis of the Jaw: Molecular and Clinical Insights. (Pubmed Central) - Feb 14, 2020
In this review we will address the involvement of osteoclasts and osteoclast-related factors in the pathogenesis of ONJ. It is to be hoped that a better understanding of the biological mechanisms underlying bone remodelling will help in the design a medical therapeutic approach for ONJ as an alternative to surgical procedures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion, Enrollment change: Denosumab Versus Bisphosphonates (Alendronate) in GIOP (clinicaltrials.gov) - Feb 12, 2020
P4, N=140, Completed,
It is to be hoped that a better understanding of the biological mechanisms underlying bone remodelling will help in the design a medical therapeutic approach for ONJ as an alternative to surgical procedures. Active, not recruiting --> Completed | N=220 --> 140
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion date, Trial initiation date, Trial primary completion date: Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) - Feb 12, 2020
P4, N=72, Not yet recruiting,
Active, not recruiting --> Completed | N=220 --> 140 Trial completion date: Dec 2023 --> Apr 2024 | Initiation date: Apr 2020 --> Jul 2020 | Trial primary completion date: Apr 2023 --> Jul 2023
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