- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Biomarker, Clinical, Journal: Individualized treatment with denosumab in children with osteogenesis imperfecta - follow up of a trial cohort. (Pubmed Central) - Jul 2, 2020
P2
On average, it was possible to prolong the intervals between drug administrations and to reduce the total dose about by 25% without a decrease of mobility or change of vertebral shape despite a reduction of lumbar aBMD during 1 year of biomarker-directed Denosumab treatment. Further trials are necessary to balance side effects and highest efficacy in children.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, P2 data, Journal: Denosumab in patients with giant-cell tumour of bone: a multicentre, open-label, phase 2 study. (Pubmed Central) - Jul 2, 2020
P2
The types and frequencies of adverse events were consistent with the known safety profile of denosumab, which showed long-term disease control for patients with GCTB with unresectable and resectable tumours. Our results suggest that the overall risk to benefit ratio for denosumab treatment in patients with GCTB remains favourable.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evenity (romosozumab) / Astellas, Amgen, UCB
Biomarker, Journal: Osteoporosis Management in the Era of COVID-19. (Pubmed Central) - Jul 1, 2020
Particular emphasis is placed on the transition from parenteral osteoporosis therapies. It is hoped that these recommendations can be used to safely guide care for patients with osteoporosis until a return to routine clinical care standards is available.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab (clinicaltrials.gov) - Jun 28, 2020
P2, N=8, Terminated,
Discrepancies between guideline recommendations and common practice should be addressed with dedicated training. N=66 --> 8 | Trial completion date: Aug 2021 --> Jun 2020 | Recruiting --> Terminated | Trial primary completion date: Jun 2021 --> Jun 2020; Due to enrollment difficulties compounded by the COVID pandemic.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Clinical, P3 data, Journal: Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial. (Pubmed Central) - Jun 28, 2020
P3
N=66 --> 8 | Trial completion date: Aug 2021 --> Jun 2020 | Recruiting --> Terminated | Trial primary completion date: Jun 2021 --> Jun 2020; Due to enrollment difficulties compounded by the COVID pandemic. Despite preclinical evidence suggesting RANKL inhibition might delay bone metastasis or disease recurrence in patients with early-stage breast cancer, in this study, denosumab did not improve disease-related outcomes for women with high-risk early breast cancer.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., pamidronate disodium / Generic mfg.
Journal: Medication-related osteonecrosis (MRONJ) of the mandible and maxilla. (Pubmed Central) - Jun 28, 2020
In 2003, Marx reported the first case of osteonecrosis of the jaw in 36 cases related to zoledronic acid or pamidronate...We present the case of a 73-year-old woman with metastatic breast cancer and MRONJ of her mandible and maxilla following treatment with intravenous zoledronic acid and denosumab...Due to her metastatic breast cancer, the extent of her necrosis and poor performance status, free flap reconstruction of her mandible was ruled out. She was treated conservatively.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: The Effect of Denosumab on Bone Mass in Super Elderly Patients. (Pubmed Central) - Jun 28, 2020
Symptomatic hypocalcemia and serious adverse drug reactions that required drug discontinuation were not observed during treatment. Denosumab is thought to be an anti-osteoporotic medication that is sufficiently effective and safe even for the super-elderly.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Parathyroid carcinoma in a 13-year-old girl with a long-term survival. (Pubmed Central) - Jun 28, 2020
Positron emission tomography of C-methionine was useful for detecting local recurrence. This patient's long-term survival has been attributed to multimodality treatment including repeated surgery, medication, and radiation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Bone metastasis treatment modeling via optimal control. (Pubmed Central) - Jun 27, 2020
In particular, we focus on denosumab treatment, an anti-resorptive therapy, and radiotherapy treatment which has a cell killing action...Moreover, we present some numerical simulations to analyze the effectiveness of both treatments when different interactions between cancer and bone cells occur. A discussion of the obtained results is provided.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed: PROUD: Preventing Osteoporosis Using Denosumab (clinicaltrials.gov) - Jun 24, 2020
P4, N=201, Active, not recruiting,
N=50 --> 0 | Not yet recruiting --> Withdrawn Suspended --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Awareness among patient at risk of developing Medication Related Osteonecrosis of the Jaw (MRONJ) - A primary prevention strategy. (Pubmed Central) - Jun 23, 2020
The sample included 68 patients, who are currently taking or will be taking Bisphosphonate (BP), and/or Denosumab, and anti-Angiogenic agent...The results of the study will help to initiate the process of providing the education materials, about the side effects and importance of oral hygiene maintenance, giving priority to improve the quality of life in such patients. Awareness of patients regarding the complications must be an important part of health care practice guidelines.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: When primary hyperparathyroidism comes as good news. (Pubmed Central) - Jun 23, 2020
If primary hyperparathyroidism is confirmed, selective parathyroidectomy is the first-line treatment. In advanced bone disease, treatment with denosumab should be considered, ensuring a strict control of Ca levels.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion, Trial completion date, Trial primary completion date: Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study (clinicaltrials.gov) - Jun 23, 2020
P2, N=10, Completed,
In advanced bone disease, treatment with denosumab should be considered, ensuring a strict control of Ca levels. Active, not recruiting --> Completed | Trial completion date: Mar 2019 --> Feb 2020 | Trial primary completion date: Mar 2019 --> Feb 2020
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Sandostatin LAR Depot (octreotide acetate) / Novartis
[VIRTUAL] I’m Not Crazy! I Get a Headache When I Pee: A Case of Metastatic Bladder Paraganglioma () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_2434;
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
[VIRTUAL] Carcinoid Causing Catastrophic Calcemia () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_2432;
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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg.
[VIRTUAL] Humoral Hypercalcemia of Malignancy Caused by Squamous Cell Carcinoma of the Penis () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_2305;
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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, raloxifene hydrochloride / Generic mfg.
[VIRTUAL] Implementation of a High-Risk Fracture Program in an Integrated Healthcare Delivery System () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_725;
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.
- |||||||||| [VIRTUAL] Management of 1,25-dihydroxyvitamin D (1,25-OHD) Mediated Hypercalcemia of Unknown Etiology () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_685;
Hypercalcemia was initially managed with hyperhydration, furosemide and calcitonin...At that point, a trial of zoledronic acid was done with subsequent resolution of hypercalcemia...Various other treatment options were considered including a repeat dose of bisphosphonate, denosumab, ketoconazole and hydroxychloroquine, but since hypercalcemia was only mild, supportive measures were continued...Infectious workup and bone marrow biopsy were negative. Although non-specific, an elevated angiotensin converting enzyme (ACE) level (359 units/L;
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
[VIRTUAL] Atypical Femur Fracture with Denosumab () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_669;
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.
[VIRTUAL] Hypercalcemia After Placement of Antibiotic-Loaded Calcium Sulfate Beads () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_659;
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. 1-3
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
[VIRTUAL] Denosumab Preserves Bone Mineral Density at the Knee in Persons with Subacute Spinal Cord Injury () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_643;
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
[VIRTUAL] Addressing the Burden of Hip Fracture in Older Men () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_624;
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
[VIRTUAL] Circulating Micrornas Linked to Bone Metabolism Are Affected by Sequential Anti Osteoporotic Treatment in Postmenopausal Osteoporosis () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_613;
The expression of circulatings miRs linked to bone metabolism during Dmab treatment is depended on previous treatment status. Patients previously on teriparatide treatment present alterations of the relative expression of miRs related to the expression of key osteoblastic genes such as RUNX-2 (miR-23), collagen type 1 (miR-29a) and HDAC5 gene (miR-2861) during subsequent treatment with Dmab Our data suggest that teriparatide may influence the subsequent anti-resorptive effect of Dmab on bone metabolism at post-transcriptional level.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, zoledronic acid / Generic mfg., Bonrise (ibandronate sodium) / Elder Pharma
[VIRTUAL] Teriparatide and Its Bone Healing Power () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_556;
There are a limited number of cases reported in regards to teriparatide induced healing of non-osteoporotic fractures (3). Our case is one of the very few reported to have shown complete radiographic and clinical healing of a traumatic, non-osteoporotic fracture after use of teriparatide for 12 weeks.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
[VIRTUAL] Severe, Symptomatic Hypocalcemia Due to Denosumab and Vitamin D Deficiency in an Osteopenic Post-Menopausal Female () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_534;
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
Journal: Denosumab Therapy Obscures Histological Features of Giant Cell Tumor of Bone. (Pubmed Central) - Jun 19, 2020
Although this effect of the drug is increasingly being recognized by soft tissue pathologists, the current case illustrates the potentially confusing histology of postdenosumab-treated GCT for neuropathologists. The absence of giant cells leads the posttherapy primary or metastatic lesion to show histologic similarity to a multitude of benign and malignant fibro-osseous lesions or spindle cell sarcoma and highlights the importance of eliciting appropriate clinical history.
- |||||||||| Prolia (denosumab) / Amgen, GSK, Daiichi Sankyo
Journal: Denosumab for giant cell tumour of bone: success and limitations. (Pubmed Central) - Jun 19, 2020
The absence of giant cells leads the posttherapy primary or metastatic lesion to show histologic similarity to a multitude of benign and malignant fibro-osseous lesions or spindle cell sarcoma and highlights the importance of eliciting appropriate clinical history. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Osteoporosis in the age of COVID-19. (Pubmed Central) - Jun 19, 2020
How can we balance urgent resourcing of our acute crisis while not abandoning the real need of patients with osteoporosis? This article offers a few practical solutions.
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