- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: RANKL inhibition halts lesion progression and promotes bone remineralization in mice with fibrous dysplasia. (Pubmed Central) - Apr 19, 2022
Although a human monoclonal anti-RANKL antibody, denosumab, has been used in FD patients, the effects and mechanisms of RANKL inhibition for FD treatment require assessment...The potent RANKL inhibitory effect and easier route of delivery make AS2676293 a promising target therapy of FD. Results from our study suggested that RANKL inhibition is effective in halting FD progression and promoting bone remineralization, which could benefit the patients with early onset of FD.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal, HEOR: Cost-effectiveness analyses of denosumab for osteoporosis: a systematic review. (Pubmed Central) - Apr 19, 2022
Generally, denosumab was more cost-effective in patients with older age, prior fracture experience, lower BMD T-scores, and more risk factors. ESCEO-IOF guidelines were more applicable to improve the transparency, generalization, and quality of pharmacoeconomic studies in osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone Targeting Agents in Patients with Prostate Cancer: General Toxicities and Osteonecrosis of the Jaw. (Pubmed Central) - Apr 15, 2022
We aim at recollecting evidence on clinical benefit of BTAs, common and specific toxicities, and explore the pathophysiology and clinical aspects of osteonecrosis of the jaw. We present a review of the literature to report the role of the different types of bone targeting agents in the management of prostate cancer with bone metastases with a particular focus on common toxicities and ONJ to recollect current evidences on the activity of these compounds and the correct management of their adverse events.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, BRCA Biomarker: Risk-Reducing Options for High-Grade Serous Gynecologic Malignancy in BRCA1/2. (Pubmed Central) - Apr 15, 2022
Several pharmacologic and surgical options exist for risk-reduction of gynecologic malignancy in BRCA 1/2 mutation carriers. This review summarizes up-to-date research on pharmacologic risk-reducing interventions, including the oral contraceptive pill, acetylsalicylic acid/nonsteroidal anti inflammatory drugs (ASA/NSAID) therapy, and denosumab, and surgical risk-reducing interventions, including risk-reducing bilateral salpingo-oophorectomy, salpingectomy with delayed oophorectomy, and hysterectomy at the time of risk-reducing bilateral salpingo-oophorectomy.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: ProliaKTx: The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients (clinicaltrials.gov) - Apr 15, 2022
P2, N=15, Terminated,
This review summarizes up-to-date research on pharmacologic risk-reducing interventions, including the oral contraceptive pill, acetylsalicylic acid/nonsteroidal anti inflammatory drugs (ASA/NSAID) therapy, and denosumab, and surgical risk-reducing interventions, including risk-reducing bilateral salpingo-oophorectomy, salpingectomy with delayed oophorectomy, and hysterectomy at the time of risk-reducing bilateral salpingo-oophorectomy. N=60 --> 15 | Trial completion date: Jun 2022 --> Dec 2021 | Recruiting --> Terminated | Trial primary completion date: Jun 2022 --> Dec 2021; Study lost funding
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Roles of the RANKL-RANK Axis in Immunity-Implications for Pathogenesis and Treatment of Bone Metastasis. (Pubmed Central) - Apr 14, 2022
In this review, we highlight the role of RANKL and RANK in the immune microenvironment and bone metastases and review data on the role of the regulatory mechanism of immunity in bone metastases, which could be verified through clinical efficacy of RANKL inhibitors for cancer patients with bone metastases. With the discovery of the specific role of RANK signaling in osteoclastogenesis, the humanized monoclonal antibody against RANKL, such as denosumab, was available to prevent bone loss, SREs, and bone metastases, providing a unique opportunity to target RANKL/RANK as a future strategy to prevent bone metastases.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: New national osteoporosis guidance-implications for geriatricians. (Pubmed Central) - Apr 12, 2022
This commentary discusses the major changes to the new, National Institute for Health and Care Excellence accredited, UK National Osteoporosis Guideline Group (NOGG) guidance (published March 2022) most relevant to the management of older people's bone health. Changes include intervention thresholds; using fracture probabilities from FRAX; for patients too frail to undergo DXA; greater emphasis on vertebral fracture detection and the use of intravenous zoledronate as a first-line anti-osteoporosis therapy; the new concept of 'very high fracture risk' which should prompt consideration of use of parenteral anti-osteoporosis therapy; new guidance regarding anabolic treatment options; concerns regarding denosumab cessation; and the urgent need to get patients with a fragility fracture onto treatment to reduce re-fracture risk with follow-up to check tolerance and ensure adherence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Pathogenesis and Treatment of Myeloma-Related Bone Disease. (Pubmed Central) - Apr 9, 2022
As the molecular mechanisms of MBD become increasingly well understood, novel agents are being thoroughly explored in both preclinical and clinical settings. Herein, we will provide an updated overview of the pathogenesis of MBD, summarize the clinical management and guidelines, and discuss novel bone-modifying therapies for further management of MBD.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab in the management of Aneurysmal bone cyst: a literature review. (Pubmed Central) - Apr 7, 2022
However, regarding the potential clinical benefits, its use might be discussed in the most advanced cases. Further research and clinical trials are mandatory to precise its belonging in the therapeutic arsenal.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Treatment of fibrous dysplasia: focus on denosumab. (Pubmed Central) - Apr 7, 2022
Denosumab is a potential therapeutic agent against FD. A combined synergic approach involving theranostics might increase its therapeutic potential.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Drug therapy for osteoporosis in older adults. (Pubmed Central) - Apr 7, 2022
Denosumab is administered by subcutaneous injection every 6 months...Romosozumab is an anti-sclerostin monoclonal antibody that stimulates bone formation and inhibits resorption...The effects of anabolic agents are transient, so transition to anti-resorptive drugs is required. The optimal strategy for cycling anabolics, anti-resorptives, and off-treatment periods remains to be determined.
- |||||||||| Prolia (denosumab) / Amgen, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Checkpoint inhibition: CHARLI: Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Apr 7, 2022
P1/2, N=72, Active, not recruiting,
The optimal strategy for cycling anabolics, anti-resorptives, and off-treatment periods remains to be determined. Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Pharmacologic Management of Metastatic Bone Disease. (Pubmed Central) - Apr 6, 2022
Bisphosphonates as well as denosumab act on the bone microenvironment and reduce the rate of skeletal related events by approximately 25%-40%...Despite the established efficacy and recommendations for their use in many international guidelines, these bone modifying agents are underutilized. This review examines the currently available guidelines on bone modifying agents in metastatic bone disease and summarizes their efficacy, risk and comparative benefits.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal, Adverse events: Adverse events associated with bone-directed therapies in patients with cancer. (Pubmed Central) - Apr 6, 2022
The purpose of this review is to familiarize clinicians with the literature regarding adverse events associated with bone-directed therapies in patients with cancer. It is important to be aware of these possible adverse events and to educate patients about the predisposing factors associated with side effects from bone-directed therapies and the preventive measures necessary to decrease the risk of occurrence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Observational data, Journal: Knowledge and attitudes of French dentists on bone resorption inhibitors (bisphosphonates and denosumab): a cross-sectional study. (Pubmed Central) - Apr 6, 2022
It is important to be aware of these possible adverse events and to educate patients about the predisposing factors associated with side effects from bone-directed therapies and the preventive measures necessary to decrease the risk of occurrence. According to our results, it is evident that there is a lack of knowledge about BRI, the risk of MRONJ, and the methods and means of preventing this complication.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, HEOR, Monotherapy: Cost-Effectiveness of Sequential Denosumab/Zoledronic Acid Compared With Zoledronic Acid Monotherapy for Postmenopausal Osteoporotic Women in China. (Pubmed Central) - Apr 5, 2022
In probabilistic sensitivity analyses, the probabilities of sequential denosumab/zoledronic being cost-effective compared to zoledronic acid monotherapy were approximately 29.3%, 68.7%, 86.1%, and 99.4% for ages 65, 70, 75, and 80 years, respectively, at the WTP threshold of $31,512/QALY. Among Chinese postmenopausal osteoporosis women over 70 years old, sequential denosumab/zoledronic acid was cost-effective compared with zoledronic acid monotherapy at the pre-determined WTP threshold.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date, Surgery, Bariatric surgery: Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery (clinicaltrials.gov) - Apr 5, 2022
P4, N=36, Recruiting,
Among Chinese postmenopausal osteoporosis women over 70 years old, sequential denosumab/zoledronic acid was cost-effective compared with zoledronic acid monotherapy at the pre-determined WTP threshold. Trial completion date: Jan 2023 --> Aug 2023 | Trial primary completion date: Jan 2023 --> Aug 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal: Treatment of Chondroblastoma with Denosumab: A Case Report with a Correlative Analysis of Effect on the RANK Signaling Pathway. (Pubmed Central) - Apr 2, 2022
Inhibition of the receptor activator of NF-κB (RANK)/RANK ligand (RANK-L) pathway with denosumab has been used neoadjuvantly for the treatment of giant cell tumor of bone, but its role in the treatment of chondroblastoma is less understood. This patient's clinical response and effect on cellular RANK/RANK-L activity support the consideration of denosumab in the treatment algorithm for other osteolytic bone tumors such as chondroblastoma.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Drug-induced osteopathy in rheumatology (Pubmed Central) - Apr 2, 2022
The treatment is the discontinuation of methotrexate and in most cases the fractures will heal within 3-4 months. Leflunomide has been associated with cases of persisting pseudarthrosis that only disappeared after a wash-out of the active metabolite.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Bone health and therapeutic agents in advanced prostate cancer. (Pubmed Central) - Apr 2, 2022
Bisphosphonates and other bone targeted agents such as denosumab have shown an improvement in bone mineral density and are suited for patients with treatment-related osteoporosis and/or bone metastases with an increased risk of skeletal-related events (SREs). In this context, the aim of this review is to analyse key aspects of bone health and therapies that can prevent the occurrence of SREs throughout the clinical course of prostate cancer, and how to combine them with new available treatments in this setting.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Review, Journal: Denosumab Discontinuation in Patients Treated for Low Bone Density and Osteoporosis. (Pubmed Central) - Apr 1, 2022
In postmenopausal women with osteoporosis, DMAB treatment for 10 years has been studied, with results showing continued gains in BMD, sustained fracture risk reduction, and low risk of adverse events. However, upon discontinuation of DMAB, there is a rapid reversal of effect, with increase in bone turnover, loss of BMD, and in a subset of patients, a greater risk for multiple vertebral fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Hypercalcemia of Malignancy. (Pubmed Central) - Apr 1, 2022
Although long-term control of HCM depends on effective management of the underlying cancer, temporizing management strategies for acute and/or symptomatic HCM include hydration and antiresorptive bone-modifying agents. Although most patients respond well to the antiresorptive therapies available, further investigation into other agents for those who are refractory to both bisphosphonates and denosumab is needed.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Drug-Related Hypercalcemia. (Pubmed Central) - Apr 1, 2022
Thiazide-induced hypercalcemia is mainly explained by enhanced renal proximal calcium reabsorption, changing preexistent asymptomatic normocalcemic or intermittently hypercalcemic hyperparathyroidism into the classic hypercalcemic hyperparathyroidism. Lithium causes hypercalcemia mainly by drug-induced hyperparathyroidism.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Treatment of Hypercalcemia of Malignancy. (Pubmed Central) - Apr 1, 2022
There is no evidence that bisphosphonates prevent the occurrence of HCM. Conversely, denosumab, compared with zoledronic acid, is associated with a lower risk of HCM, both first episode and recurrence, in patients with breast cancer and multiple myeloma.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Anabolic Therapy in Postmenopausal Osteoporosis (clinicaltrials.gov) - Apr 1, 2022
P4, N=46, Recruiting,
These findings indicate that the two treatment strategies are equally effective in preventing osteoporotic fractures in subjects with diabetes. Not yet recruiting --> Recruiting
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