- |||||||||| hydroxychloroquine / Generic Mfg., hydroxychloroquine / VG Lifesciences
Case Study: A Report on the Efficacy of Hydroxychloroquine in Treating Hypercalcemia (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_2823;
Antimalarial agents such as chloroquine and hydroxychloroquine are known to impair production of 1,25-OH Vitamin D by blocking 1-alpha--hydroxylase activity...Her calcium level remained elevated in spite of stopping daily Vitamin D3 supplementation and treatment with Denosumab injections...This case demonstrates the efficacy of hydroxychloroquine in the treatment of hypercalcemia, by directly inhibiting the 1-alpha-hydroxylase activity. Based on this mechanism of action it should be considered as a treatment strategy in any disease resulting in 1-alpha hydroxylase overproduction.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Hypophosphatemia and Fibroblast Growth Factor 23 Producing Metastatic Breast Cancer (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_2808;
Patient was initiated on monthly denosumab one year prior to current visit, with last dose one month ago, for metastatic bone involvement...Recognition of TIO is essential since patients that have solitary lesions may undergo resection which may be curative. In patients with several lesions or metastatic cancer, medical therapy can be attempted to improve the quality of life.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Retrospective data, Journal: Giant cell tumor of bone: Unusual features of a rare tumor. (Pubmed Central) - Oct 11, 2019
Denosumab can be used in the treatment of pulmonary metastasis, multicentric and recurrent giant cell tumor of bone. Due to late recurrence and malignant transformation, a prolonged follow-up is warranted.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: An Update on the Comprehensive Approach to Fragility Fractures. (Pubmed Central) - Oct 9, 2019
Antiresorptive agents such as bisphosphonates and denosumab are first-line treatments for osteoporosis and anabolic agents such as Teriparatide are effective in reducing bone density loss and have implications in fracture healing. In addition, new anabolic agents including anti-sclerostin antibodies and parathyroid hormone-related protein show promise as potential treatments to increase bone density.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J
Journal: A new osteoclastogenesis pathway induced by cancer cells targeting osteoclast precursor cells. (Pubmed Central) - Oct 8, 2019
Quantitative RT-PCR analysis showed that the expression of NFATc1 was decreased in this tumor-associated osteoclastogenesis, which was suggested to be independent of NFATc1. These results revealed a novel pathway for tumor-associated osteoclastogenesis, which may be a new therapeutic target for osteolysis induced by tumors infiltrating into the bone without affecting systemic bone metabolism.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Randomized Control Study in Glucocorticoid-Induced Osteoporosis Treated with Bisphosphonate or Denosumab (GOBID) (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_3211;
Medications, risedronate (17.5mg/W or 75mg/M, group B) or denosmab (60mg/6M, group P), were randomly assigned to the patients...The demographics of the group B and the group P were as follow, the number: 48/41 (B/P); female: 42/31; Age (mean): 66.0/70.6; prednisolone: 6.1/7.3mg/day; l-BMD; 0.959/0.928g/cm2; prevalent deformity at spine: 52/49%... These results suggest that denosmab is effective and safe for treatment of glucocorticoid-induced osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Effect of Discontinuation of Denosumab in Subjects with Rheumatoid Arthritis Treated with Glucocorticoids (B207-B208) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2911;
In this small subgroup of GC-treated subjects with RA, BMD gains achieved with denosumab were lost upon discontinuation, consistent with observations in postmenopausal women receiving denosumab for osteoporosis. In this analysis of short-term denosumab use in subjects with RA receiving GCs, bone turnover was reduced with denosumab and gradually returned to baseline upon discontinuation, without a clear increase to above-baseline levels in the off-treatment period.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Extensive Modeling-Based Bone Formation After 2 Months of Romosozumab Treatment: Results from the FRAME Clinical Trial (B207-B208) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2909;
P3
In FRAME, postmenopausal women aged ≥55 years with osteoporosis (BMD T-score ≤–2.5 and >–3.5 at the total hip or femoral neck) were randomized 1:1 to 210 mg Romo or Pbo SC QM for 12 months, followed by 60 mg denosumab SC Q6M for 12 months. These data show that stimulation of bone formation in the first 2 months of Romo treatment is predominately due to increased MBBF on the Ec and Cn surfaces.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Geisinger HiROC Performance 2017-2018: Continuing to Narrow the Post-Fracture Treatment Gap (B207-B208) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2908;
Prior performance analyses show HiROC treatment rates of 75-80 % (Table 2). Despite our program’s maturity, we face several ongoing barriers: patient activation/engagement and fear of FDA-approved medications; access to and/or cost of parenteral medications or anabolic agents; and inability to use database to capture care gaps in real time and correct/solve them.
- |||||||||| Who Prescribed Which Osteoporosis Medication to Whom (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1134;
Internal medicine and family doctors should remain updated regarding osteoporosis treatment-related research results. A study limitation is that prescriber information was not complete for IV medications.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Treatment of bone metastases: bisphosphonates and denosumab (Pubmed Central) - Oct 4, 2019
This usually incurable condition involves serious consequences, as fractures, pain, surgeries, irradiations, plegias, hypercalcemia, etc. (skeletal-related events, SREs), which destroy the quality of life. Targeting bone resorption with bisphosphonates or RANK ligand dependent mechanism could improve the rate of serious SREs and disease-free survival.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Denosumab in the treatment of glucocorticoid-induced osteoporosis. (Pubmed Central) - Oct 4, 2019
Denosumab contributes to increased bone mineral density and decreased bone-turnover marker levels among glucocorticoid users. It is an effective therapeutic option with a favourable safety profile in glucocorticoid-induced osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Review, Journal: Osteoporosis-frequent comorbidity in patients with rheumatism (Pubmed Central) - Oct 4, 2019
In the case of a T-score ≤-1.5 a specific drug treatment with bisphosphonates, teriparatide or denosumab should be started together with optimizing preventive measures, such as reduction of glucocorticoid dosage, calcium and vitamin D intake and life style modifications. The risk of osteonecrosis of the jaw (ONJ) in patients with osteoporosis is small; however, there appears to be a significant increase in multiple vertebral fractures after discontinuation of denosumab.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date: RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints (clinicaltrials.gov) - Oct 3, 2019
P2, N=100, Active, not recruiting,
The risk of osteonecrosis of the jaw (ONJ) in patients with osteoporosis is small; however, there appears to be a significant increase in multiple vertebral fractures after discontinuation of denosumab. Recruiting --> Active, not recruiting | Trial completion date: Jan 2020 --> Jun 2020 | Trial primary completion date: Sep 2018 --> Jun 2019
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Denosumab-related hypocalcaemia in chronic kidney disease. (Pubmed Central) - Oct 2, 2019
These observations call into question the concept that denosumab can be used as a stand-alone alternative to bisphosphonates to treat children with OI. No abstract available
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, imatinib / Generic Mfg., Nexavar (sorafenib) / Bayer, Amgen
Review, Journal: Is there a magic bullet for sarcomas? : Personalised treatment for maligant tumours of bone and soft tissue (Pubmed Central) - Sep 27, 2019
More in-depth knowledge is required for many sarcomas to link their genetic alterations to tumorigenesis in order to develop efficient personalised treatment strategies. Clinical trial designs need to be adapted to evaluate new therapeutic strategies in these ultra-rare tumours and their various sub-types more efficaciously.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Bone-Targeted Agents in Breast Cancer: Do We Now Have All the Answers? (Pubmed Central) - Sep 27, 2019
The bone-targeted agents (BTAs), bisphosphonates and denosumab, have an established role in the treatment of metastatic breast cancer bone disease and the prevention of cancer-treatment-induced bone loss...The reason for the lack of efficacy of BTAs in premenopausal/perimenopausal patients still remains unanswered and will need preclinical research to evaluate novel treatment combinations with BTAs in this patient group. This review covers the past, present, and future indications for BTAs in both metastatic and early breast cancer.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date: Denosumab and Male Infertility: a RCT (clinicaltrials.gov) - Sep 26, 2019
P2, N=95, Active, not recruiting,
Active, not recruiting --> Completed | N=24 --> 33 Trial completion date: Jan 2021 --> Jun 2020 | Trial primary completion date: Jan 2021 --> Jun 2020
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Presurgical Trial of Denosumab in Breast Cancer (clinicaltrials.gov) - Sep 26, 2019
P1, N=35, Recruiting,
Evidence on EBR and Sr89 is limited and less conclusive. Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2019 --> Jun 2020
- |||||||||| Veramyst (fluticasone furoate nasal spray) / GSK
DIFFUSE PULMONARY OSSIFICATION (DPO): AN INFREQUENT FORM OF INTERSTITIAL LUNG DISEASE (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 4) - Sep 25, 2019 - Abstract #CHEST2019CHEST_2486;
Disease course appears variable with some displaying no symptoms, while others see either clinical or radiographic progression. The latter occurred in this patient.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Impact of RANKL inhibition on tumor microenvironment of early-stage breast cancer, a pre-surgical trial (Hall 1 - Poster Session 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1023;
With 10 subjects with tumors with high RANK/RANKL expression at baseline, a change from baseline of a single gene of >|1.7| standard deviations between subjects with and without RANK/RANKL expression is detectable based on a 2-sided two sample t-test with power of 80% and false discovery rate of 10%. Differential gene expression analysis will be performed comparing denosumab treated patients with RANK/RANKL+ vs. RANK/RANKL- BC, and between treated patients and untreated controls.PRESENT ACCRUAL: 29 of the planned 35 patients have been enrolled to date.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, cyclophosphamide intravenous / Generic mfg., Abraxane (albumin-bound paclitaxel) / Otsuka, BMS
Moved to GS3-01 Investigating denosumab as an add-on treatment to neoadjuvant chemotherapy and two different nab-paclitaxel schedules in a 2x2 design in primary breast cancer - First results of the GeparX study (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_661;
Methods GeparX, a phase II study, was planned to randomize 778 patients to NACT+/-denosumab (120mg s.c. q4w for 6 cycles), stratified by lymphocyte predominant BC (?50% vs >50% stromal tumor infiltrating lymphocytes [sTILs]), subtype (HER2-/HR+ vs triple negative (TNBC) vs HER2+), and epirubicin/cyclophosphamide (EC, q2w vs q3w)...Carboplatin was given in TNBC and ABP 980 + pertuzumab (biosimilar substudy) in HER2+ BC...Conclusions The results of the primary endpoints and selected secondary endpoints will be presented at the meeting. Funding: The trial was financially supported by Amgen and Celgene
- |||||||||| Prolia (denosumab) / Amgen
Trial initiation date: Markers of Osteoporosis in Cystic Fibrosis (clinicaltrials.gov) - Sep 24, 2019
P4, N=100, Not yet recruiting,
Funding: The trial was financially supported by Amgen and Celgene Initiation date: Jul 2019 --> Dec 2019
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Abraxane (albumin-bound paclitaxel) / Otsuka, BMS
Investigating denosumab as an add-on treatment to neoadjuvant chemotherapy and two different nab-paclitaxel schedules in a 2x2 design in primary breast cancer - First results of the GeparX study (Hall 3) - Sep 23, 2019 - Abstract #SABCS2019SABCS_212;
Methods GeparX, a phase II study, was planned to randomize 778 patients to NACT+/-denosumab (120mg s.c. q4w for 6 cycles), stratified by lymphocyte predominant BC (≤50% vs >50% stromal tumor infiltrating lymphocytes [sTILs]), subtype (HER2-/HR+ vs triple negative (TNBC) vs HER2+), and epirubicin/cyclophosphamide (EC, q2w vs q3w)...Carboplatin was given in TNBC and ABP 980 + pertuzumab (biosimilar substudy) in HER2+ BC...Conclusions The results of the primary endpoints and selected secondary endpoints will be presented at the meeting. Funding: The trial was financially supported by Amgen and Celgene.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Actonel (risedronate) / Sanofi
Review, Journal: Update on osteoporosis treatment. (Pubmed Central) - Sep 22, 2019
Zoledronate or denosumab will be indicated in cases of digestive intolerance, poor adherence or an increased risk of hip fracture. Teriparatide will be indicated to patients with 2or more previous vertebral fractures or very low bone density.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Influence of specific osteoporosis drugs on fracture healing (Pubmed Central) - Sep 22, 2019
Following a fragility fracture, osteoporosis should be diagnosed according to the guidelines and, if necessary, treated with specific osteoporosis drugs, since in principle they do not impair fracture healing but significantly reduce the risk of subsequent fractures. Approval to improve fracture healing requires further investigations.
- |||||||||| CMAB807 (denosumab biosimilar) / 3SBio
Enrollment closed: Phase 1 Study to Compare CMAB807 Injection to Prolia (clinicaltrials.gov) - Sep 19, 2019
P1, N=132, Active, not recruiting,
Approval to improve fracture healing requires further investigations. Not yet recruiting --> Active, not recruiting
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