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110 Diseases |  |
151 Trials |
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151 Trials |  |
7120 News |  |
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- | Prolia (denosumab) / Amgen
Journal: Novel genetic mutation associated with hyperphosphatemic familial tumoral calcinosis/hyperostosis-hyperphosphatemia syndrome treated with denosumab: a case report. (Pubmed Central) - Jun 25, 2024
Increased levels of inorganic phosphorus (Pi) and C-reactive protein were observed. After treating the patient with conventional drugs, we tested denosumab, which reduced but did not normalize the Pi.
- ||| Prolia (denosumab) / Amgen
Journal, Adverse events, Adverse drug reaction: Analysis of adverse drug reactions of Denosumab (Prolia) in osteoporosis based on FDA adverse event reporting system (FAERS). (Pubmed Central) - Jun 25, 2024
Attention should also be paid to newly discovered ADRs, such as immobile, menopausal symptoms, etc., to avoid more serious consequences. Cohort studies, more detailed and comprehensive case information, and long-term clinical investigations are needed to confirm these results and to further understand the safety profile of Denosumab (Prolia).
- | Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
New P4 trial: Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study (clinicaltrials.gov) - Jun 23, 2024
P4, N=63, Not yet recruiting, Sponsor: Tuen Mun Hospital
- || Prolia (denosumab) / Amgen
Retrospective data, Review, Journal, Real-world evidence, Real-world: Denosumab, for osteoporosis, reduces the incidence of type 2 diabetes, risk of foot ulceration and all-cause mortality in adults, compared with bisphosphonates: An analysis of real-world, cohort data, with a systematic review and meta-analysis. (Pubmed Central) - Jun 20, 2024
Cohort studies, more detailed and comprehensive case information, and long-term clinical investigations are needed to confirm these results and to further understand the safety profile of Denosumab (Prolia). This is the largest cohort study to show that denosumab treatment is associated with a reduced RR of incident T2D, as well as an associated reduced RR of all-cause mortality and microvascular complications, findings that may influence guideline development in the treatment of osteoporosis, particularly in patients who are at a high risk of T2D.
- | Prolia (denosumab) / Amgen
Journal, Surgery: Thoracic giant cell tumor after two total en bloc spondylectomies including one emergency surgery: A case report. (Pubmed Central) - Jun 20, 2024
This patient with acute paraplegia underwent TES twice, including once in an emergency, and achieved good therapeutic results. TES in emergency surgery is feasible and safe when conditions permit; however, it may increase the risk of tumor recurrence.
- | Prolia (denosumab) / Amgen
Journal: Denosumab-induced bone changes in a child: a case report. (Pubmed Central) - Jun 17, 2024
TES in emergency surgery is feasible and safe when conditions permit; however, it may increase the risk of tumor recurrence. We present the case of a 9-year-old girl who developed striking bone changes following two years of denosumab therapy for giant cell lesions of the jaw.
- || Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone (clinicaltrials.gov) - Jun 17, 2024
P4, N=70, Recruiting, Sponsor: Hospital for Special Surgery, New York
We present the case of a 9-year-old girl who developed striking bone changes following two years of denosumab therapy for giant cell lesions of the jaw. Trial completion date: Jan 2023 --> Jun 2026 | Trial primary completion date: Jul 2022 --> Apr 2026
- | Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia (clinicaltrials.gov) - Jun 16, 2024
P2, N=15, Recruiting, Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Trial completion date: Jan 2023 --> Jun 2026 | Trial primary completion date: Jul 2022 --> Apr 2026 Trial completion date: Jun 2025 --> Jan 2026 | Trial primary completion date: Jun 2025 --> Jan 2026
- | Prolia (denosumab) / Amgen
Journal: Safety and Efficacy of Denosumab in Children With Osteogenesis Imperfecta-the First Prospective Comparative Study. (Pubmed Central) - Jun 16, 2024
However, denosumab should be used with caution in pediatric patients with OI because of its common and dangerous side effect of rebound hypercalcemia. The appropriate dosage and dosing interval of denosumab need to be further explored in children with OI.
- | Prolia (denosumab) / Amgen
Journal: Efficacy and safety of denosumab versus zoledronic acid in OI adults: A prospective, open-label, randomized study. (Pubmed Central) - Jun 16, 2024
Denosumab effectively increases aBMD in adults with OI, with similar efficacy to zoledronic acid. Long-term and large-sample studies are needed to confirm the antifracture efficacy and safety of denosumab in adult patients with OI.
- || Prolia (denosumab) / Amgen
Review, Journal: Bone health in patients with inflammatory bowel disease. (Pubmed Central) - Jun 14, 2024
From a therapeutic perspective, besides good disease control, vitamin D supplementation and glucocorticoid sparing, several specific osteological options are available: bisphosphonates, receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors (denosumab), parathyroid hormone (PTH) analogues and selective estrogen receptor modulators. This review provides an overview of the pathophysiology, diagnosis, prevention and treatment of IBD-associated bone loss.
- | Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Study of Denosumab for Prevention of Skeletal Disease Progression in Children With Fibrous Dysplasia (clinicaltrials.gov) - Jun 14, 2024
P2, N=15, Recruiting, Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
This review provides an overview of the pathophysiology, diagnosis, prevention and treatment of IBD-associated bone loss. Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
- | Prolia (denosumab) / Amgen
Journal: Reshrinkage of Giant-Cell Tumor of the Bone in the Thoracic Vertebrae after Resumption of Denosumab Treatment: A Case Report. (Pubmed Central) - Jun 13, 2024
Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025 No abstract available
- | Prolia (denosumab) / Amgen
Journal: Pathogenesis of Medication-Related Osteonecrosis of the Jaw: Odontogenic Infection-Preceding Type and Osteonecrosis-Preceding Type. (Pubmed Central) - Jun 13, 2024
In multivariate analysis, non-odontogenic MRONJ was significantly more common in patients with no osteolysis and with periosteal reaction. Conclusion Non-odontogenic MRONJ tends to occur more frequently in patients treated with high-dose DMB, and there were significantly more cases of non-osteolytic MRONJ without radiographic evidence of osteolysis or with periosteal reactions.
- || Prolia (denosumab) / Amgen
Review, Journal: Is denosumab an efficient and safe drug for osteoporosis in dialysis patients? Considerations and state of the art about its use in this setting. (Pubmed Central) - Jun 10, 2024
Conclusion Non-odontogenic MRONJ tends to occur more frequently in patients treated with high-dose DMB, and there were significantly more cases of non-osteolytic MRONJ without radiographic evidence of osteolysis or with periosteal reactions. Denosumab emerges as a potentially safe and effective option for enhancing bone health in CKD patients.
- | Prolia (denosumab) / Amgen
Journal: Denosumab and metatarsal fracture healing: potential benefits with delayed remodeling: a case report. (Pubmed Central) - Jun 7, 2024
Denosumab may positively influence fracture healing in older adults with metatarsal fractures, potentially leading to delayed remodeling. However, further studies are needed to confirm these observations.
- ||| Prolia (denosumab) / Amgen
Enrollment open: Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia (clinicaltrials.gov) - Jun 6, 2024
P1, N=225, Recruiting, Sponsor: Xentria, Inc.
However, further studies are needed to confirm these observations. Not yet recruiting --> Recruiting
- | Prolia (denosumab) / Amgen
Journal: Atypical metatarsal fracture in a Chinese postmenopausal woman with osteoporosis on long-term denosumab: a case report. (Pubmed Central) - Jun 6, 2024
Not yet recruiting --> Recruiting No abstract available
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: Long-Term Bone Mineral Density Changes in Kidney Transplant Recipients Treated with Denosumab: A Retrospective Study with Nonequivalent Control Group. (Pubmed Central) - Jun 5, 2024
No significant differences in serum creatinine, hypocalcaemic events or acute graft rejection rates were observed. Four years of denosumab therapy were associated with increased BMD in KTRs, while untreated KTRs showed significant BMD losses at all sites.
- | Prolia (denosumab) / Amgen
Journal: Case report: Recurrent severe hypocalcemia secondary to denosumab in a patient with chronic kidney disease. (Pubmed Central) - Jun 4, 2024
Four years of denosumab therapy were associated with increased BMD in KTRs, while untreated KTRs showed significant BMD losses at all sites. No abstract available
- | Prolia (denosumab) / Amgen
Journal: Denosumab discontinuation: COVID-19 pandemic and beyond. (Pubmed Central) - Jun 3, 2024
However, independent of the "emergency" that occurred during the COVID-19 pandemic, there are other situations in which denosumab is discontinued. In such situations, it is important to have a programmed strategy to optimize care while limiting the risk for unwanted outcomes.
- ||| Prolia (denosumab) / Amgen
Journal, Adverse events: Drug-related hypophosphatemia: Descriptive study and case/non-case analysis of the French national pharmacovigilance database. (Pubmed Central) - Jun 2, 2024
For hydrochlorothiazide, hyphosphatemia was often moderate, associated with other electrolytic disturbances and occurred during a long-term treatment. Awareness of healthcare professionals is essential to detect as soon as possible hypophosphatemia and its complications related to these drugs.
- Prolia (denosumab) / Amgen
SECONDARY PREVENTION OF OSTEOPOROSIS: CLINICAL AND FUNCTIONAL PROFILE OF ELDERLY PATIENTS WITH HIP FRACTURE () - May 29, 2024 - Abstract #EULAR2024EULAR_4447;
Previous fractures often go untreated, which leads to new fractures that compromise the patients' quality of life, independence and survival. Hip fractures show high rates of morbidity and mortality.
- Prolia (denosumab) / Amgen, Edirol (eldecalcitol) / Roche, Taisho
MEASUREMENT OF 25(OH)VITAMIN D AND THE EFFECTIVENESS OF NUTRITIONAL GUIDANCE IN PATIENTS WITH RHEUMATIC DISEASES () - May 29, 2024 - Abstract #EULAR2024EULAR_4439;
Patients were able to increase their 25(OH) D levels without medication with nutritional guidance. The effectiveness of denosumab and Ca/VD should be clarified in follow-up studies.
- Prolia (denosumab) / Amgen
FRACTURE RISK FOLLOWING DENOSUMAB DISCONTINUATION IN THE ONCOLOGIC POPULATION: INCIDENCE AND RISK FACTORS () - May 29, 2024 - Abstract #EULAR2024EULAR_4428;
OF occurred in 13% of patients after discontinuing DENO, a rate comparable to that observed in common osteoporosis. This OF rebound supports the ESMO recommendation to consider bisphosphonate therapy after discontinuing DENO.
- Prolia (denosumab) / Amgen
FACTORS AFFECTING PERSISTENCE OF DENOSUMAB TREATMENT IN PATIENTS WITH OSTEOPOROSIS: A RETROSPECTIVE COHORT STUDY () - May 29, 2024 - Abstract #EULAR2024EULAR_4426;
Denosumab treatment persistence is significantly influenced by patient's cognitive status, use of more than 5 drugs, and having received previous osteoporosis treatments. These factors should be considered when initiating long-term treatments, reevaluating the type of treatment, and reinforcing follow-up for these patients.
- Prolia (denosumab) / Amgen
EVALUATING OSTEOPOROSIS AND RELEVANT FACTORS IN RHEUMATOLOGICAL PATIENTS RECEIVING GLUCOCORTICOID THERAPY () - May 29, 2024 - Abstract #EULAR2024EULAR_4423;
GIOP was significantly associated with age, disease duration, and steroid dose and duration. To avoid the development of GIOP, it is advised that GC be used in clinical practice at the lowest effective dose and for the shortest time feasible.
- Prolia (denosumab) / Amgen
EFFECTS OF LONGTERM ORAL BISPHOSPHONATE THERAPY IN PATIENTS WITH OSTEOPOROSIS: WHAT DO WE DO NEXT? () - May 29, 2024 - Abstract #EULAR2024EULAR_4422;
A third of patients sustained further fractures whilst on treatment. There is no consensus on course of treatment after 10 years of bisphosphonates and study looks at clinical decision making for treatment continuation.
- Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
COMPARATIVE EFFECTIVENESS OF OSTEOPOROSIS MEDICATIONS ON DISEASE ACTIVITY IN RHEUMATIC MUSCULOSKELETAL DISORDERS () - May 29, 2024 - Abstract #EULAR2024EULAR_3970;
Fracture risk might mediate the effect of osteoporosis medications and disease activity control. Larger pragmatic trials are warranted.
- Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
CLINICLAL EFFICACY OF SEQUENTIAL TREATMENT AFTER ROMOSOZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS COMPARISON WITH PRIMARY OSTEOPOROSIS FOR 24 MONTHS () - May 29, 2024 - Abstract #EULAR2024EULAR_3446;
Objectives: To evaluate the clinical efficacy of ROMO for 12 months and denosumab (DMB) for 12 months in patients with RA-OP comparison with primary osteoporosis (P-OP) for 24 months. Clinical efficacy of treatment with ROMO for 12months and DMB for 12months was extremely effective for RA-OP as well as for P-OP and has the high potential to be an important option in the treatment of RA-OP.
- Prolia (denosumab) / Amgen
IMPACT OF GLUCOCORTICOIDS ON THE THERAPEUTIC EFFICACY OF DENOSUMAB IN OSTEOPOROSIS OF RHEUMATOID ARTHRITIS PATIENTS (Poster Tour 3) - May 29, 2024 - Abstract #EULAR2024EULAR_2841;
Clinical efficacy of treatment with ROMO for 12months and DMB for 12months was extremely effective for RA-OP as well as for P-OP and has the high potential to be an important option in the treatment of RA-OP. Our results suggest that GIOP dose of GC attenuates the therapeutic efficacy of denosumab in increasing BMD in RA, particularly in the subgroup of patients negative for anti-CCP antibodies.
- ||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Trial completion: AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - May 28, 2024
P1, N=208, Completed, Sponsor: Alvotech Swiss AG
Our results suggest that GIOP dose of GC attenuates the therapeutic efficacy of denosumab in increasing BMD in RA, particularly in the subgroup of patients negative for anti-CCP antibodies. Active, not recruiting --> Completed
- | Prolia (denosumab) / Amgen
Observational data, Journal: The Effect of Denosumab on Rotator Cuff Repair in Women Aged 60 and over with Osteoporosis: A Prospective Observational Study. (Pubmed Central) - May 25, 2024
This result suggests that denosumab administration might be beneficial for rotator cuff healing, particularly in the context of osteoporosis, a known risk factor for increased retear rates. Therefore, comprehensive osteoporosis screening and treatment should be considered in conjunction with rotator cuff repair surgery in middle-aged women.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: Radiographical Diagnostic Evaluation of Mandibular Cortical Index Classification and Mandibular Cortical Width in Female Patients Prescribed Antiosteoporosis Medication: A Retrospective Cohort Study. (Pubmed Central) - May 24, 2024
Forty-nine patients were using AOM (13 nonbisphosphonate/denosumab and 36 bisphosphonate/denosumab)...In the MCI classification, DPR imaging among the AOM group was more sensitive (0.95) than that of the control group. This method of estimating osteoporosis based on MCI classification using DPR images has high sensitivity, especially in patients using AOM, suggesting that this method is useful as a screening test.
- | Prolia (denosumab) / Amgen
Journal: Too Much of a Good Thing: Severe Hypercalcemia Presenting with Lethargy and Kidney Failure. (Pubmed Central) - May 23, 2024
Milk alkali syndrome was diagnosed given the history of high-dose calcium / vitamin D supplementation after ruling out other causes of hypercalcemia. After initial treatment with normal saline, furosemide and denosumab, the patient developed severe symptomatic hypocalcemia as a rare adverse effect of denosumab.
- | Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Major Pancreatic Resection Increases Bone Mineral Density Loss, Osteoporosis, and Fractures. (Pubmed Central) - May 22, 2024
After pancreatic resection, patients are at higher risk for BMD loss and subsequent fractures. As the cohort of pancreatic resection survivorship grows, attention will need to be paid to focused prevention efforts to reduce BMD loss, osteoporosis, and fractures in these vulnerable patients, with specific attention to the pancreatic cancer population.
- | Prolia (denosumab) / Amgen
Journal: A Case of Giant Cell Tumor of the Fibula. (Pubmed Central) - May 22, 2024
As the cohort of pancreatic resection survivorship grows, attention will need to be paid to focused prevention efforts to reduce BMD loss, osteoporosis, and fractures in these vulnerable patients, with specific attention to the pancreatic cancer population. No abstract available
- | Prolia (denosumab) / Amgen, Avastin (bevacizumab) / Roche
Journal: Hydrogel formats to model potential drug interactions occurring at the subcutaneous injection site. (Pubmed Central) - May 19, 2024
No abstract available HA
- || Prolia (denosumab) / Amgen
Retrospective data, Review, Journal: The Risk of Neurological Deterioration While Using Neoadjuvant Denosumab on Patients with Giant Cell Tumor of the Spine Presenting with Epidural Disease: A Meta-Analysis of The Literature. (Pubmed Central) - May 16, 2024
The most appropriate dosage and duration of denosumab therapy is yet to be determined. We recommend future well-designed studies to further evaluate the use of neoadjuvant denosumab for patients with spinal GCT.
- | Prolia (denosumab) / Amgen
Journal, HEOR: Comparative effectiveness of Denosumab vs alendronate among postmenopausal women with osteoporosis. (Pubmed Central) - May 16, 2024
In this cohort of almost half-a-million treatment-naive women with PMO, we observed clinically significant reductions in the risk of MOP, hip, NV, NHNV, and HV fractures for patients on denosumab compared with alendronate. Patients who remained on denosumab for longer periods of time experienced greater reductions in fracture risk.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: The Effectiveness of Denosumab in Middle Eastern Patients With Giant Cell Tumor of the Bone: A Single-Center, Retrospective Study. (Pubmed Central) - May 16, 2024
Denosumab does not seem to provide superior long-term outcomes compared to surgery alone. Although our findings are generally consistent with other studies in the literature, larger long-term studies are needed to confirm our findings.
- | Prolia (denosumab) / Amgen
Journal: Osteoporosis management in Australian aged care facilities: a mixed method study. (Pubmed Central) - May 15, 2024
A need to raise awareness of aged care-specific consensus recommendations concerning vitamin D and calcium is evident. Facility protocols and procedures must be developed and implemented to ensure safe and effective use of denosumab.
- | Prolia (denosumab) / Amgen
Enrollment closed: Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation (clinicaltrials.gov) - May 13, 2024
P=N/A, N=20, Active, not recruiting, Sponsor: University of Calgary
Facility protocols and procedures must be developed and implemented to ensure safe and effective use of denosumab. Recruiting --> Active, not recruiting
- | Prolia (denosumab) / Amgen
Journal: Local radiographic risk factors for MRONJ in osteoporotic patients undergoing tooth extraction. (Pubmed Central) - May 13, 2024
Recruiting --> Active, not recruiting Tooth extraction sites showing radiographic signs of chronic dental infection are prone to MRONJ.
- || Prolia (denosumab) / Amgen
Review, Journal: Links among Obesity, Type 2 Diabetes Mellitus, and Osteoporosis: Bone as a Target. (Pubmed Central) - May 11, 2024
Bisphosphonates and denosumab significantly reduced the risk of vertebral fractures in patients with both obesity and T2DM...It is important to recognize elevated fracture risk and osteoporosis in obese and T2DM patients, as they are currently considered low risk and tend to be underdiagnosed and undertreated. The implementation of better diagnostic tools, including trabecular bone score, lumbar spine BMD/body mass index (BMI) ratio, and microRNAs to predict bone fragility, could improve fracture prevention in this patient group.
- || Prolia (denosumab) / Amgen
Review, Journal: Modern treatment of unicameral and aneurysmatic bone cysts. (Pubmed Central) - May 10, 2024
The historical treatment with intraosseous injection of methylprednisolone acetate into the bone cysts nowadays is reduced due to the morbidity of multiple injections and the risk of multiple pathologic fractures until the healing...Further studies are needed to confirm the effectiveness of denosumab and its side effects on skeletally immature patients...For simple bone cysts, the combination of curettage, bone graft, and ESIN showed the best results. Sclerotherapy for ABC also shows promising results.
- | Prolia (denosumab) / Amgen
Journal: Denosumab-related osteonecrosis of the external auditory canal-benefit of the early surgical management. (Pubmed Central) - May 9, 2024
The authors highlight several similarities with medication-related osteonecrosis of the jaw. Therefore, an analogous disease staging and treatment rationale is suggested.
- Prolia (denosumab) / Amgen
Observational data, Retrospective data, Journal: Secondary fracture prevention in Spanish primary care: results of the PREFRAOS Study. (Pubmed Central) - May 9, 2024
Across Spanish PC, we observed a large gap in the treatment and follow-up of elderly subjects experiencing a fragility fracture. Our data highlights the urgent need to improve secondary fracture prevention in PC.
- | Prolia (denosumab) / Amgen
Retrospective data, Journal: Preventing Loss of Femoral Periprosthetic Bone Mineral Density in Cementless Total Hip Arthroplasty Using a Tapered Wedge Stem: A Retrospective, Cohort Study in Osteoporotic Patients Treated with Denosumab. (Pubmed Central) - May 9, 2024
Denosumab significantly increased proximal femoral periprosthetic BMD in zone 1 and prevented loss of BMD in zone 7 in patients with osteoporosis after cementless THA using a tapered wedge stem at both seven and 12 months. Future studies of denosumab treatment following THA in patients with osteoporosis should focus on clinical outcomes such as the risk of periprosthetic fracture and revision THA.
- | Prolia (denosumab) / Amgen
Journal: Denosumab-Associated Severe Hypocalcemia in Dialysis-Dependent Patients-Reply. (Pubmed Central) - May 8, 2024
Future studies of denosumab treatment following THA in patients with osteoporosis should focus on clinical outcomes such as the risk of periprosthetic fracture and revision THA. No abstract available