- |||||||||| enzalutamide capsule / Generic mfg.
Journal, Metastases: Myocardial bridge in a patient with castration-resistant metastatic prostate cancer treated with enzalutamide. (Pubmed Central) - Jun 7, 2023 Due to the high prevalence of prostate cancer in elderly patients at high cardiovascular risk and the increasing use of androgen receptor-targeted agent, a multidisciplinary approach is highly recommended to weigh survival benefits on toxicities. This case report may support the use of androgen receptor-targeted agent in elderly patients with controlled cardiovascular diseases, a population that is often excluded from randomised trials.
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Journal: Refractory hypercalcemia of malignancy: a problem with many potential roots. (Pubmed Central) - Jun 6, 2023 Here we discuss drivers of hypercalcemia of malignancy and the physiologic mechanisms whereby they operate to increase serum calcium. Additionally, we discuss multiple available treatments targeted to a given contributory mechanism and also briefly discuss potential future treatments in need of further study.
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Enrollment open, Trial initiation date: Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2) (clinicaltrials.gov) - May 31, 2023 P4, N=200, Recruiting, Nevertheless, further studies with a wider patient population are required to understand the long-term impacts. Not yet recruiting --> Recruiting | Initiation date: Feb 2023 --> May 2023
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Trial completion date, Trial primary completion date: Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) - May 30, 2023 P=N/A, N=508215, Active, not recruiting, Not yet recruiting --> Recruiting | Initiation date: Feb 2023 --> May 2023 Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Apr 2023 --> Sep 2023
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Enrollment closed, Trial completion date, Trial primary completion date: Bisphosphonates for Prevention of Post-Denosumab Bone Loss (clinicaltrials.gov) - May 26, 2023 P2, N=27, Active, not recruiting, Inhibition of RANKL may be a feasible strategy for this subset of patients. Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Jan 2024
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Review, Journal: RANKL inhibition: a new target of treating diabetes mellitus? (Pubmed Central) - May 24, 2023 Denosumab (Dmab), a fully human monoclonal antibody that can bind to RANKL and prevent osteoclast formation, is a commonly used antiosteoporosis drug...Besides, some clinical data have also reported the glucometabolic effects of Dmab, however, with limited and inconsistent results. This review mainly describes the impact of the RANKL signaling pathway on glucose metabolism and summarizes clinical evidence that links Dmab and DM to seek a new therapeutic strategy for diabetes.
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Review, Journal: An overview of the management of osteoporosis in the aging female population. (Pubmed Central) - May 23, 2023 The importance of sequence in the use of osteoporotic medicine is also highlighted in the article. An understanding of the different treatment options will hopefully help in the management of this very common and debilitating condition.
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Trial completion date, Trial primary completion date: MITO: Muscle Impact of Treating Osteoporosis (clinicaltrials.gov) - May 23, 2023 P4, N=40, Recruiting, An understanding of the different treatment options will hopefully help in the management of this very common and debilitating condition. Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
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Retrospective data, Review, Journal: The Clinical Effectiveness of Denosumab (Prolia (Pubmed Central) - May 22, 2023 TRACP-5b, especially the baseline value, may predict the efficacy of sequential therapy from RMAb, as well as previous treatments. To assess the effectiveness and safety of denosumab (Prolia
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Review, Journal: Immune Dysfunction in Medication-Related Osteonecrosis of the Jaw. (Pubmed Central) - May 17, 2023 The pathogenesis of medication-related osteonecrosis of the jaw (MRONJ) is multifactorial and there is a substantial consensus on the role of antiresorptive drugs (ARDs), including bisphosphonates (BPs) and denosumab (Dmab), as one of the main determinants...Here, we summarized the main effects of ARDs on the different immune cell subsets, which consequently affect bone cells, particularly osteoclasts and osteoblasts. Data from animal models and MRONJ patients showed a deep interference of ARDs in modulating immune cells, even though a large part of the literature concerns the effects of BPs and there is a lack of data on Dmab, demonstrating the need to further studies.
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Trial initiation date, Trial primary completion date: Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva (clinicaltrials.gov) - May 17, 2023 P1, N=252, Not yet recruiting, Data from animal models and MRONJ patients showed a deep interference of ARDs in modulating immune cells, even though a large part of the literature concerns the effects of BPs and there is a lack of data on Dmab, demonstrating the need to further studies. Initiation date: Apr 2023 --> Jul 2023 | Trial primary completion date: Feb 2024 --> May 2024
- |||||||||| Nerixia (nerindronic acid) / Abiogen, Grunenthal, Takeda, Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Treatment for osteoporosis in people with beta-thalassaemia. (Pubmed Central) - May 13, 2023 Denosumab may make little or no difference to BMD, and we are uncertain about the effect of strontium on BMD. We recommend further long-term RCTs on different bisphosphonates and zinc supplementation therapies in people with beta-thalassaemia-associated osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed: Anabolic Therapy in Postmenopausal Osteoporosis (clinicaltrials.gov) - May 12, 2023 P4, N=50, Active, not recruiting, We recommend further long-term RCTs on different bisphosphonates and zinc supplementation therapies in people with beta-thalassaemia-associated osteoporosis. Recruiting --> Active, not recruiting
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Denosumab Associated Severe Hypocalcemia Due To Vitamin D Deficiency In a Patient With Undiagnosed Primary Hyperparathyroidism (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2436; This explains the severe and prolonged hypocalcemia caused by Denosumab owing to its mechanism of action and long elimination half life, in our patient with Vitamin D deficiency on the background of malabsorption, despite a combination of primary and secondary elevation of PTH. Careful baseline assessment of calcium and Vitamin D levels, along with adequate supplementation and regular monitoring should be undertaken in all patients treated with Denosumab to avoid this.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Darzalex (daratumumab) / J&J
A Case of Severe Hypocalcemia After Treatment of Plasma Cell Leukemia (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2429; In our case, the cause of hypocalcemia was thought to be multifactorial; low magnesium and Vitamin D may be implicated, but a rapid uptake of calcium and magnesium into bone, with a profound release of ineffective PTH seems a likely reason for the dramatic protracted and severe course of hypocalcemia. This case offers insights into an extremely rare presentation of hypocalcemia with a mechanism not too dissimilar to hungry bone syndrome.
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Hungry Bone Syndrome Secondary to Denosumab Use in a Patient With Sleeve Gastrectomy (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1833; Another take away for physicians is to pay special attention to medication reconciliation on admission as medications like Prolia could easily be missed given the infrequent administration. Careful risk stratification & prophylactic supplementation is required in such patients to prevent hypocalcemia.
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Complicated Course and Management after Denosumab Discontinuation: A Case Report (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1831; Past bone health history was notable for treatment with alendronate for approximately 11 years as a premenopausal woman...Labs were only notable for hypercalciuria for which hydrochlorothiazide (HCTZ) was initiated...Thus in 1/2022, she started romosozumab (ROMO) in an attempt to prevent new VFx...In 5/2022, she received a dose of zoledronic acid (ZOL)...In addition, this report does not support transitioning from long-term DMAb to ROMO in order to prevent a rapid increase in the bone resorption marker, CTX. Rather, treatment with ZOL every 12 weeks based on frequent CTX monitoring successfully maintained BMD stable following long-term DMAb discontinuation.
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Teriparatide as treatment for severe osteoporosis in lung transplant recipients (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1827; Given that severe osteoporosis is highly prevalent in LTx patients and that fractures often continue to occur after treatment with anti-resorptive medication, teriparatide should be further studied as an alternative treatment in this clinical setting. Our experience in four patients suggest it is safe and effective.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Atypical Femur Fractures in Antiresorptive- Therapy-Na (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1821; In lieu of a 2nd dose of denosumab, romosozumab was started and she was promptly scheduled for prophylactic, orthopedic femoral nailing. This bisphosphonate-na
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