- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Efficacy of Romosozumab for Glucocorticoid-induced Osteoporosis in Patients with Rheumatic Diseases; A Prospective Study (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3969;
This is the first study to analyze the effect of ROMO on GIO, but further validation in a large number of cases is needed. Demographics and clinical data at baseline of the study population Percent change of BMD in lumbar spine and femoral neck Serum levels of BAP, P1NP, OC, NTX and TRACP-5b, and urine pentosidine M. Kawazoe: Asahi Kasei Pharma Corp, 6, AstraZeneca, 6, Ayumi Pharmaceutical Corporation, 6, GlaxoSmithKlein(GSK), 6; K. Kaneko: AbbVie/Abbott, 6, AstraZeneca, 6, Boehringer-Ingelheim, 6, Bristol-Myers Squibb(BMS), 6, Eli Lilly, 6, Gilead, 6, GlaxoSmithKlein(GSK), 6, Janssen, 6, Novartis, 6, Pfizer, 6, UCB, 6;
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
How to Tailor Osteoporosis Therapies in Patients with Advanced Liver Disease? Variations of Renal Function by Creatinine and Cystatin C (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3967;
In a setting of advanced liver disease eligible for transplantation, renal function estimates significantly varied depending on the GFR equation used, thus largely modifying the rates of patients with a contraindication for using bisphosphonates, despite the high fracture risk. Further studies are necessary to establish the best method to assess renal function in advanced liver disease patients to tailor anti-OP strategies.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Soluble Buffered Alendronate After Denosumab Discontinuation in Erosive Hand OA Patients (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3304;
Clinical implications of the increase of bone turnover markers in this non osteoporotic remain doubtful, since BMD values did not change over time, except at the lumbar spine in the 24 weeks alendronate group. Longer follow-up is warranted to evaluate clinical consequences on long term.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Comparative Effectiveness of Denosumab versus Zoledronic Acid Among Postmenopausal Women with Osteoporosis in the U.S. Medicare Program (Room 11A-B; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_2031;
J. Curtis: AbbVie, 2, 5, Amgen, 2, 5, BMS, 2, 5, Corrona, 2, 5, Crescendo, 2, 5, Genentech, 2, 5, Janssen, 2, 5, Pfizer, 2, 5, Roche, 2, 5, UCB Pharma, 2, 5; T. Arora: Amgen, 5;
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Cardiovascular Risk and Fracture Risk Among Women Initiating Treatment with Romosozumab or Denosumab (Room 33A-C; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1790;
In this cohort of older women with claims data linked to EHR data, patients with high CV risk were less likely to be given romo compared with dmab. These data suggest that the boxed warning regarding CV risk for romo appropriately influences clinical decision making of physicians when prescribing anabolic medications for osteoporosis patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Clinical, Review, Journal: Pharmacological agents for bone fracture healing: talking points from recent clinical trials. (Pubmed Central) - Sep 23, 2023
Concerning the effect of parathormone, current level I evidence is controversial, and additional studies are required. Level I, systematic review of RCTs.
- |||||||||| Strensiq (asfotase alfa) / AstraZeneca, Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Atypical Femoral Fracture in Hypophosphatasia: A Systematic Review. (Pubmed Central) - Sep 21, 2023
Nine patients (32.1%) received antiresorptive medication (bisphosphonate and/or denosumab), and two patients (7.1%) received teriparatide prior to the development of AFF...Four (14.3%) and seven (25.0%) patients received asfotase alfa and teriparatide after sustaining AFF...Based on the limited evidence, AFF occurred in up to 10% of patients with HPP. Based on the 28 case reports, about two-thirds did not receive antiresorptive treatment, suggesting that the HPP itself could potentially be a risk factor for AFF.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review: Are medication-induced salivary changes the culprit of osteonecrosis of the jaw? A systematic review. (Pubmed Central) - Sep 18, 2023
In addition, bisphosphonates, denosumab, and other bone-modifying agents showed a significantly higher risk of developing MRONJ owing to the changes in salivary microbiome profiles, cytokine profiles, interleukins, hypotaurine, and binding proteins...However, due to the availability of limited evidence, the findings of the review should be interpreted with caution. https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022327645.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Denosumab Use in Chronic Kidney Disease Associated Osteoporosis: A Narrative Review. (Pubmed Central) - Sep 18, 2023
The findings suggest that denosumab reduces the risk of fractures and improves bone mineral density in all stages of CKD. The results of this review support the use of denosumab as a promising option for managing bone disease in CKD and HD patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Influence of non-osteoporotic treatments in patients on active anti-osteoporotic therapy: evidence from the OSTEOMED registry. (Pubmed Central) - Sep 18, 2023
The potential beneficial or detrimental effects of the different drugs evaluated on fracture risk are masked by treatment with anabolic or antiresorptive drugs that have a more potent action on bone metabolism, with two exceptions: letrozole and oral corticosteroids. These findings may have important clinical implications, as patients receiving these treatments are not fully protected by bisphosphonates, which may imply the need for more potent anti-osteoporotic drugs such as denosumab or teriparatide.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Osteoporosis treatment with denosumab in routine clinical practice in Poland. (Pubmed Central) - Sep 15, 2023
The article presents detailed sociodemographic and disease-related characteristics of patients who routinely implemented denosumab therapy. Most of them continued denosumab for at least 12 months, with increased BMD T-scores.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
12S103: Controversies and Updates in Osteoporosis Management (Room 6A-B; in person) - Sep 15, 2023 - Abstract #ACRConvergence2023ACR_Convergence_279;
Despite well-established methods for screening and diagnosing osteoporosis, as well as a number of FDA-approved therapies for treatment, there remains a number of unanswered questions. This session will focus on common dilemmas in day-to-day management of osteoporosis, including monitoring with markers, Learning Objectives: Identify strategies to safety transition a patient from denosumab to an alternative osteoporosis therapy safely Illustrate situations where the use of bone turnover markers can assist in the management of osteoporosis Address when to follow 25-hydroxyvitamin D levels and how to manage vitamin D status in light of the VITAL Study Results
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical, Journal, Real-world evidence, Real-world effectiveness, Real-world: Real-World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study. (Pubmed Central) - Sep 13, 2023
This session will focus on common dilemmas in day-to-day management of osteoporosis, including monitoring with markers, Learning Objectives: Identify strategies to safety transition a patient from denosumab to an alternative osteoporosis therapy safely Illustrate situations where the use of bone turnover markers can assist in the management of osteoporosis Address when to follow 25-hydroxyvitamin D levels and how to manage vitamin D status in light of the VITAL Study Results Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ?55?years after initiating treatment for ?6?months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014-2016.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Investigation of Giant Cell Tumor of Bone and Tissue Engineering Approaches for the Treatment of Giant Cell Tumor of Bone. (Pubmed Central) - Sep 12, 2023
The most often prescribed medication for GCTB is Denosumab, a RANKL (receptor activator of nuclear factor ?B ligand) inhibitor...This review summarizes and discusses GCTB, the disease, its cellular composition, various bone tumor models, and their properties and utilization in research. As a result, this study delves deep into in vitro testing, which is vital for scientists and physicians in various fields, including pharmacology, preclinical investigations, tissue engineering, and regenerative medicine.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Anti-sclerostin antibodies: a new frontier in fragility fractures treatment. (Pubmed Central) - Sep 11, 2023
Clinical studies and guidelines suggest romosozumab as an initial drug in an ideal sequential approach from osteoanabolic to antiresorptive drugs. Some aspects of cardiovascular safety remain to be fully investigated, therefore its use in osteoporotic patients at high cardiovascular risk should be avoided until further data become available.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Real-world evidence of bisphosphonates and denosumab for Multiple Myeloma (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_335;
Analyses have been performed after propensity scoring matching by age, sex, bone fractures in the 3 months prior to diagnosis, bone disease and previous treatment with corticosteroids, calcium and vitamin D. Patients treated with bisphosphonates included: Pamidronate and Zolendronic acid. This large-scale study based on real-world data confirms the bisphosphonates and denosumab prolong survival in MM, with no differences between them.
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment open: AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - Sep 5, 2023
P1, N=206, Recruiting,
This study provides significant information about the intellectual structure and global productivity of PHPT to clinicians and other researchers interested on PHPT. Not yet recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Osteoporosis management in primary care. (Pubmed Central) - Sep 2, 2023
Safe, efficacious, and economical medications are available, but osteoporosis remains underdiagnosed and undertreated. Bisphosphonates, selective estrogen receptor modulators (raloxifene), conjugated estrogens/bazedoxifene, estrogen therapy/hormone therapy, parathyroid hormone analogues, RANK ligand inhibitors (denosumab), sclerostin inhibitors (romosozumab), and calcitonin are all drugs or drug classes commonly used to treat osteoporosis that are discussed in this article.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Osteoporosis: treatment of high-risk patients (Pubmed Central) - Sep 1, 2023
Every bone anabolic treatment requires an antiresorptive follow-up treatment. Drug holidays are only possible in exceptional cases for high-risk patients.
- |||||||||| Prolia (denosumab) / Amgen
Trial completion: Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (clinicaltrials.gov) - Sep 1, 2023
P2, N=25, Completed,
Drug holidays are only possible in exceptional cases for high-risk patients. Active, not recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Basics of Denosumab-Therapy aftercare (Pubmed Central) - Aug 31, 2023
Active, not recruiting --> Completed No abstract available
- |||||||||| Prolia (denosumab) / Amgen
Enrollment open: Study of XGEVA (clinicaltrials.gov) - Aug 31, 2023
P4, N=35, Recruiting,
No abstract available Not yet recruiting --> Recruiting
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment open: AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - Aug 24, 2023
P=N/A, N=206, Recruiting,
Both ZOL and Dmab are suggested to be effective sequential treatments after TPT. Active, not recruiting --> Recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Sequential Therapy for the Long-Term Treatment of Postmenopausal Osteoporosis. (Pubmed Central) - Aug 23, 2023
This review will also examine the notion that long-term treatment with an antiresorptive drug may diminish the efficacy of subsequent treatment with a bone-forming/dual-acting drug. Finally, this review will explore the current evidence pertaining to the specific issue of how to best prevent the clinical ramifications of denosumab cessation.
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