- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo, zoledronic acid / Generic mfg.
Clinical, Journal: Bone-targeted agent treatment patterns and the impact of bone metastases on patients with advanced breast cancer in the United States. (Pubmed Central) - Feb 7, 2020
Safety and efficacy were the main factors considered by physicians when selecting BTAs. Past Presentations: Data previously presented at the ISPOR 18th Annual European Congress, Milan, Italy; November 7-11, 2015 and at the Breast Cancer Symposium, San Francisco, CA, USA; September 25-27, 2015.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Asahi Kasei
Journal: Bone-targeted therapy in castration-resistant prostate cancer: where do we stand? (Pubmed Central) - Feb 7, 2020
New data about dosing schedules and combinations of different treatments will continue to refine the optimal strategy for incorporating BTAs into the new treatment paradigms for PCa. Novel molecules such as PSMA-targeted small molecules promise theranostic agents in the management of PCa patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Evaluation of the Timeliness of Serial Denosumab Administrations at the University of Colorado Hospital (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_3170;
We reviewed the charts of 98 individuals who received 111 instances of late doses between 7/6/16-8/11/18. The most prevalent reasons for delays were: delays in follow-up by the patient (27.9%), delays in the provider placing an order for the drug and OIC referral simultaneously (27.9%), and delays in OIC scheduling (18%).
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Sandostatin LAR Depot (octreotide acetate) / Novartis
I'm Not Crazy! I Get a Headache When I Pee: A Case of Metastatic Bladder Paraganglioma (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_3102;
Because they are likely to recur and to metastasize, annual follow up with a measurement of plasma and urinary catecholamine levels and cystoscopy are essential. A functional imaging study (Ga-DOTATE scan) should be done to locate recurrence if symptoms reappear or catecholamine resurgence occurs.
- |||||||||| leucovorin calcium / Generic mfg., fluorouracil / Generic mfg., Afinitor (everolimus) / Novartis
Carcinoid Causing Catastrophic Calcemia (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_3098;
He was switched to Everolimus but did not respond to that and was readmitted mere weeks later for symptomatic hypercalcemia and a combination of Folinic acid, Fluorouracil, and Oxaliplatin (Folfox) was started...This patient had a rare tumor, producing an uncommon hormone, and required extensive treatment. This case shows the importance of a multidisciplinary approach in patients with hypercalcemia secondary to carcinoid tumors but refractory to traditional therapy.
- |||||||||| Management of 1,25-dihydroxyvitamin D (1,25-OHD) Mediated Hypercalcemia of Unknown Etiology (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2946;
Granulomatous form of CVID is a rare entity but should be considered in a patient presenting with 1,25-OHD mediated hypercalcemia and hypogammaglobulinemia. Treatment of this entity during an ongoing diagnostic workup can be challenging, particularly if the use of steroids is contraindicated due to potential interference with diagnostic investigations.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Decadron (dexamethasone) / Merck (MSD)
Bisphosphonate and Denosumab Refractory Hypercalcemia of Malignancy: What Else Is at Play? (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2944;
This case highlights the importance of ancillary work up of hypercalcemia when a patient's calcium is refractory to standard anti-resorptive therapy. Moreover, it shows the need for a systematic approach when treating hypercalcemia.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Atypical Femur Fracture with Denosumab (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2938;
Not many cases of AFF have been reported with the use of DM and most of the reported cases are associated with prolonged BP therapy. Our case is unusual in that AFF occurred in the absence of prolonged BP therapy and raises concern that a couple of ZA infusions in the past can also increase the risk of AFF.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., furosemide / Generic mfg.
Hypercalcemia After Placement of Antibiotic-Loaded Calcium Sulfate Beads (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2925;
Higher bead volume may be associated with more significant hypercalcemia. 1 Although previous cases have reported milder hypercalcemia, our cases demonstrate that hypercalcemia can be more severe and prolonged, necessitating dialysis in addition to traditional therapies.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Risk Factors of Denosumab Induced Hypocalcemia in Korean Patients with Osteoporosis (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2436;
In linear mixed model, decrease in the corrected calcium level in 3 months was more prominent in hypocalcemia group compared to and non-hypocalcemia group (P for interaction <0.001), with the restoration of calcium level at 6 months. Conclusion : Although moderate hypocalcemia was rare with denosumab treated patients for osteoporosis, patients with low serum calcium, renal dysfunction, or on loop diuretics should require clinical attention for hypocalcemia during denosumab treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Addressing the Burden of Hip Fracture in Older Men (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2428;
Implementing targeted post-hip fracture intervention in men dramatically increased osteoporosis treatment following fracture, with the largest intervention seen 2-4 months after fracture. The high burden of prevalent fractures, smoking, and diabetes highlights the need for post-fracture intervention and counseling for modifiable risk factors.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Denosumab Preserves Bone Mineral Density at the Knee in Persons with Subacute Spinal Cord Injury (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_2413;
P4
At 18 months, pQCT at the 4% tibial region confirmed the DXA findings at proximal tibial; at the 38% tibial region, a trend toward loss of total volumetric BMD (vBMD) was observed (-0.7% ± 4.5 vs. -16.9% ± 20.0, p<0.09), but cortical vBMD was similar between the denosumab and placebo groups, suggesting trabecular loss at the tibial shaft. In summary, the findings suggest that denosumab, if treatment is initiated within 3 months of acute SCI, appears to be an efficacious approach to maintain BMD at the knee and hip regions.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evomate (raloxifene hydrochloride) / Shreya Life Sciences
Implementation of a High-Risk Fracture Program in an Integrated Healthcare Delivery System (Room 207) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1991;
However, treatment of fractures in women already targeted by HEDIS-based intervention did not increase. Future studies should address potential barriers to treatment and assess the impact of added high-risk fracture outreach on adherence to therapy.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
Treatment with Zoledronic Acid Subsequent to Denosumab Cannot Fully Prevent Bone Loss (Room 207) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1987;
These data will help to foster treatment decisions in postmenopausal women at high risk for VFx. Treatment with ZOL irrespective of the timing did not fully prevent loss of BMD in patients with osteopenia.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
Humoral Hypercalcemia of Malignancy Caused by Squamous Cell Carcinoma of the Penis (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1897;
Denosumab may be a more effective treatment option than a bisphosphonate based on the therapeutic experience in this case and others. PTHrP-related hypercalcemia appears to be a strong indicator of limited life expectancy for penile carcinoma as for other malignancies.
- |||||||||| hydroxychloroquine / Generic mfg.
Hypercalcemia Secondary to Calcitriol and PTHrP Cosecretion Only Responsive to Hydroxychloroquine (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1400;
Control of both calcitriol and calcium levels did not occur until initiation of hydroxychloroquine despite preceding use of high-dose glucocorticoids and anti-resorptive therapy. Our case suggests that hydroxychloroquine should be considered in cases of calcitriol-mediated hypercalcemia resistant to glucocorticoids, particularly as it has less drug interactions and a more favorable side effect profile when compared to ketoconazole.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Severe, Symptomatic Hypocalcemia Due to Denosumab and Vitamin D Deficiency in an Osteopenic Post-Menopausal Female (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1388;
The first is to ensure a patient receiving denosumab is also taking supplemental Vitamin D and calcium to prevent hypocalcemia and to periodically measure serum levels to rule out deficiency. The second is the emphasis on having a provider-patient discussion on alternative therapies when the patient may no longer be a candidate for denosumab while considering the patient's risk for fracture.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Calcium Level in a Patient with Rhabdomyolysis. A Tale of Two Phases. (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1384;
He received Calcitonin 500 IU BID for three days and Denosumab 120 mg SC in order to control the hypercalcemia along with, cautious intravenous hydration...Conclusion : hypercalcemia can complicate the recovery phase of rhabdomyolysis. Careful monitoring of calcium levels and management are warranted.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Denosumab as an add-on Neoadjuvant Treatment (GeparX) (clinicaltrials.gov) - Feb 7, 2020
P2, N=780, Active, not recruiting,
Careful monitoring of calcium levels and management are warranted. Trial completion date: Dec 2019 --> Oct 2020 | Trial primary completion date: Oct 2019 --> Dec 2019
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Evaluating the impact of regulatory action on denosumab-induced hypocalcaemia in Japan. (Pubmed Central) - Jan 30, 2020
That there was no apparent increase in the prevalence of denosumab-induced hypocalcaemia, suggests that the regulatory action had an impact in the clinical setting studied. Such regulatory actions may play an important role in the promotion of drug safety.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Multiple vertebral fractures after denosumab discontinuation (Pubmed Central) - Jan 29, 2020
One of the women also had symptomatic hypoparathyroid hypercalcaemia, six months after denosumab was discontinued. We recommend, that denosumab treatment should not be stopped without considering an alternative treatment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB, zoledronic acid / Generic mfg., Asahi Kasei
Journal: Osteoporosis (Pubmed Central) - Jan 28, 2020
There is no benefit of vitamin D supplementation on musculoskeletal health in the general population, but vitamin D remains indicated in patients with vitamin D deficiency or receiving osteoporosis treatment. A sequential treatment with romosozumab during one year, a bone anabolic anti-sclerostin antibody, followed by two years of denosumab, decreases vertebral and non-vertebral fractures with rapid and substantial BMD gains after 3 years.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Excess of second tumors in denosumab-treated patients: a metabolic hypothesis. (Pubmed Central) - Jan 27, 2020
A sequential treatment with romosozumab during one year, a bone anabolic anti-sclerostin antibody, followed by two years of denosumab, decreases vertebral and non-vertebral fractures with rapid and substantial BMD gains after 3 years. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Osteoporosis-specific treatment when and how? (Pubmed Central) - Jan 26, 2020
Based on the current guidelines of the governing body for osteology (DVO) the indications for specific medicinal treatment can be determined. Furthermore, the selection of the suitable osteoporosis medication can be carried out by considering several factors, including individual ones.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Interrogating the cell-of-origin of BRCA1 mutant ovarian cancer to inform targeted strategies for cancer prevention (Trade Area Level 2&3) - Jan 24, 2020 - Abstract #LCC2020LCC_101;
Recent studies have identified a RANK-positive luminal progenitor population of cells that are a putative cell-of-origin of BRCA1mut/+ breast cancer; this population has proven targetable with the RANK ligand inhibitor denosumab and an international randomised phase III prevention study to assess the efficacy of denosumab treatment in preventative therapy for BRCA1 mutation carriers commenced in 2019...Single cell RNA-sequencing of murine fallopian tube cells has further resolved a previously unidentified population of fallopian tube epithelial cells. Using a Pax8 promoter-driven mouse model of BRCA1-mutant HGSOC which recapitulates the human disease, we are investigating Pax8+ subsets in ovarian cancer to identify putative targets for ovarian cancer prevention in BRCA1 mutation carriers.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: A Case of Non-Treated Prostate Cancer with Disseminated Intravascular Coagulopathy (Pubmed Central) - Jan 24, 2020
After successful treatment with CAB, denosumab, and thrombomodulin alpha, the DIC levels improved (DIC score=3 points), and the PSA levels decreased to 51.5 ng/ml on the 47th day. DIC has been known to occur during treatment for prostate cancer ; however, cases of DIC with prostate cancer without any treatment are rare.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Giant Cell Tumor of Extracraniofacial Bone - Clinicopathological Analysis of 263 Cases (LACC West Exhibit Hall A, Poster Board Number: 70) - Jan 24, 2020 - Abstract #USCAP2020USCAP_1963;
Only mitotic count was significant among pathological findings, which has not been reported previously. We have done neither radiological analysis nor analysis of metastatic disease, yet.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Observational data, Journal: Patterns of care for patients with metastatic bone disease in solid tumors: A cross-sectional study from Switzerland (SAKK 95/16). (Pubmed Central) - Jan 24, 2020
The majority of physicians (70.9%) reported prescribing BTAs in line with international guidelines; denosumab was the treatment of choice in 78.5% of patients...This cross-sectional, non-interventional study found high implementation of guideline-recommended BTA prescribing, good pain control and low incidence of skeletal-related events. Long-term BTA randomized controlled trials have the potential to further optimize routine care outcomes for patients.
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