- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: New insights in the pathophysiology, epidemiology and response to treatment of osteoporotic vertebral fractures. (Pubmed Central) - Oct 22, 2023 Endocrinologists should be aware of the high likelihood of osteoporotic VFs in patients with endocrine diseases. Though licensed treatments are able to substantially reduce the occurrence of VFs in patients with osteoporosis, the vast majority of recent or ongoing randomized controlled trials in the VF area focus on advanced invasive therapy of the fracture itself.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New P4 trial: A Study of Romosozumab (EVENITY (clinicaltrials.gov) - Oct 12, 2023 P4, N=100, Not yet recruiting,
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Anabolic and Antiresorptive Osteoporosis Treatment: Trends, Costs, and Sequence in a Commercially Insured Population, 2003-2021. (Pubmed Central) - Oct 9, 2023 Though licensed treatments are able to substantially reduce the occurrence of VFs in patients with osteoporosis, the vast majority of recent or ongoing randomized controlled trials in the VF area focus on advanced invasive therapy of the fracture itself. New anabolic medications (abaloparatide and romosozumab) were recently approved for osteoporosis, and data suggest that prescribing antiresorptive medications after a course of anabolic medications offers better outcomes..
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: OPTIMIST: The Optimised Use of Romozosumab Study (clinicaltrials.gov) - Oct 5, 2023 P4, N=270, Recruiting, New anabolic medications (abaloparatide and romosozumab) were recently approved for osteoporosis, and data suggest that prescribing antiresorptive medications after a course of anabolic medications offers better outcomes.. Not yet recruiting --> Recruiting
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment closed, Trial completion date, Trial primary completion date: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Oct 3, 2023 P3, N=30, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Jan 2025 --> Sep 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: The antifracture efficacy of vitamin D in adults - are we assessing it reliably? A systematic review. (Pubmed Central) - Oct 2, 2023 The analysed studies did not conclusively assess the vitamin D antifracture efficacy in patients with prestudy low serum vitamin levels, due to the lack of assessment of whether sufficient doses of vitamin D were used. They informed about the relevant doses and preparations of vitamin D in particular groups (specific fracture risk, age, place of residence) only.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Observational data, Retrospective data, Journal: Efficacy of Three Teriparatide Preparations and Romosozumab, Osteogenesis Promoters, in the Treatment of Fresh Vertebral Fractures: A Retrospective Observational Study. (Pubmed Central) - Sep 28, 2023 They informed about the relevant doses and preparations of vitamin D in particular groups (specific fracture risk, age, place of residence) only. Daily, weekly, and twice-weekly administration of TPD may be superior to ROMO for promoting fresh vertebral fracture healing.
- |||||||||| Review, Journal: Effect of agents affecting bone homeostasis on short- and long-term implant failure. (Pubmed Central) - Sep 26, 2023
In addition, implant-related sequestration in patients who received anti-resorptive therapy, despite of successful osseointegration, is also noticeable. Although limited studies are available at present, clinicians should still carefully consider the potential hazards and take appropriate precautions to minimize the risks associated with the medications and implant therapy.
- |||||||||| 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;
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Compliance with Romosozumab and Fracture Risk Among Postmenopausal Women in the U.S (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3804; In this cohort of women with high fracture risk and using administrative claims data linked to EHR data, romo users who had baseline higher fracture risk had poorer treatment compliance. These data suggest that physician should focus more on improving treatment adherence when prescribing new therapy such as romo for vulnerable patients with higher fracture risk.
- |||||||||| 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.
- |||||||||| 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, 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.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Sclerostin: clinical insights in muscle-bone crosstalk. (Pubmed Central) - Aug 31, 2023 This narrative review provides an overview of the clinical implications of sclerostin modulation on skeletal muscle mass and function, and bone metabolism. Improving knowledge about muscle-bone crosstalk may represent a turning point in the development of therapeutic strategies for musculoskeletal disorders, particularly osteosarcopenia.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Retrospective data, Review, Journal: Efficacy of osteoporosis pharmacological treatments in men: a systematic review and meta-analysis. (Pubmed Central) - Aug 28, 2023 Medications used in the management of osteoporosis in women appear to provide similar benefits in men with osteoporosis. Therefore, the algorithm for the management of osteoporosis in men could be similar to the one previously recommended for the management of osteoporosis in women.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Sclerostin and Cardiovascular Disease. (Pubmed Central) - Jul 25, 2023 One study also suggested that sclerostin lowering increases coronary artery calcification. Triangulation of evidence from different sources provides some suggestion that sclerostin lowering increases MI risk, supporting the need for CVD risk assessment when considering treatment with romosozumab.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Diagnosis and management of osteoporosis in Saudi Arabia: 2023 key updates from the Saudi Osteoporosis Society. (Pubmed Central) - May 26, 2023 Further research is needed to develop medications for adults with OI that will lead to definite fracture rate reduction. This updated guideline is for all healthcare professionals involved in osteoporosis and post-fracture care and management in SA and harmonized the most up-to-date changes in the field based on evidence-based medicine for use in the local setting.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Bridging the Gap: Pregnancy-And Lactation-Associated Osteoporosis. (Pubmed Central) - May 13, 2023 The first case using romosozumab was reported in 2022. PAO/LAO remains a challenging condition which is a battle for the wellbeing of two individuals, on one hand, considering maternal-fetal outcomes and taking care of the offspring, but it is a battle for a multidisciplinary team, on the other hand, since a standardized approach is lacking.
- |||||||||| 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, PAO/LAO remains a challenging condition which is a battle for the wellbeing of two individuals, on one hand, considering maternal-fetal outcomes and taking care of the offspring, but it is a battle for a multidisciplinary team, on the other hand, since a standardized approach is lacking. Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
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.
- |||||||||| 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
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Sclerostin Inhibitor Use in the Medical Management of Osteogenesis Imperfecta Type III (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_210; Sclerostin inhibitors are an option for the medical treatment of OI. Further investigation is needed to determine long-term safety, optimal duration, and use of sclerostin inhibitors in combination with antiresorptive agents in OI.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Repairing Skeletal Deterioration in Diabetes with Bone Anabolic Therapies (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_173; Further investigation is needed to determine long-term safety, optimal duration, and use of sclerostin inhibitors in combination with antiresorptive agents in OI. Herein, we demonstrate bone restoration in a preclinical model of established diabetes by two bone anabolic pathways: activation of the PTH1 receptor, with equimolar doses of either PTH (1-34) or Abaloparatide/ABL (100/95
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Retrospective data, Review, Journal: Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials. (Pubmed Central) - May 7, 2023 Bone anabolic treatments were more effective than bisphosphonates in the prevention of clinical and vertebral fractures, irrespective of baseline risk indicators. Hence this analysis provided no clinical evidence for restricting the use of anabolic treatment to patients with a very high risk of fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
DESIGN AND OPTIMIZATION OF DRUG COMBINATION THERAPIES FOR OSTEOPOROSIS VIA SIMULATIONS OF BONE TURNOVER (Focussed Oral Room 1) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1286; Therefore, there is a large potential to improve pharmacologic therapies of osteoporosis using physiological simulations. For renal patients beyond CKD stage 3, a restricted set of drug types may be considered to account for contraindications related to impaired renal clearance.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Preclinical, Review, Journal: Pharmaceutical treatment of bone loss: From animal models and drug development to future treatment strategies. (Pubmed Central) - Apr 10, 2023 Despite the considerable progress in drug development, there is still a clear need to improve treatment strategies and develop new pharmaceuticals against various types of osteoporosis. The review also highlights that new treatment indications should be explored using multiple animal models of bone loss in order to ensure a broad representation of different types of skeletal deterioration instead of mainly focusing on primary osteoporosis from post-menopausal estrogen deficiency.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Trial completion: Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta (clinicaltrials.gov) - Apr 6, 2023 P1, N=25, Completed, The review also highlights that new treatment indications should be explored using multiple animal models of bone loss in order to ensure a broad representation of different types of skeletal deterioration instead of mainly focusing on primary osteoporosis from post-menopausal estrogen deficiency. Active, not recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: A systematic review of cost?effectiveness analyses of sequential treatment for osteoporosis. (Pubmed Central) - Mar 30, 2023 Generally, the sequential treatments involving abaloparatide, romosozumab, denosumab, and bisphosphonates may be considered as the preferred option for osteoporosis with high fracture risk, while the sequential treatment with teriparatide was not a cost-effectiveness strategy. The ESCEO-IOF and CHEER (2022) increase the transparency, comparability, extrapolation, and quality of research, engage patients and the general public in research on health services and policies, and help improve the quality of health technology assessment.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Osteoporosis: Common Questions and Answers. (Pubmed Central) - Mar 20, 2023 Patients at high risk of fracture should consider treatment with antiresorptive therapy, including bisphosphonates and denosumab. Anabolic agents such as teriparatide, abaloparatide, and romosozumab should be considered for patients at very high risk or with previous vertebral fractures.
- |||||||||| Evenity (romosozumab) / Astellas, Amgen, UCB
Journal: Romosozumab Use and Cardiovascular Events. (Pubmed Central) - Mar 20, 2023 Anabolic agents such as teriparatide, abaloparatide, and romosozumab should be considered for patients at very high risk or with previous vertebral fractures. No abstract available
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Osteoporosis Treatment Ranking in Postmenopausal Women at High Risk of Fracture in Brazil: MCDA Approach () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_2300; Risk-based treatment decisions may allow for more appropriate medication selection. Even though treatment preferences vary between groups, our results showed that romosozumab had the highest score (relative proximity) for all stakeholder groups, considering preferences and the performance matrix evidence for both treatments.
|