- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Spontaneous Vertebral Fractures in The Setting of Prolonged CRRT (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1819;
He had received pulse dose prednisone for presumed post-viral myocarditis...A dose of Denosumab was given for treatment with improvement of calcium clearance during CRRT.DiscussionAcute fractures and infrequently, prolonged immobilization cause hypercalcemia with suppression of PTH...Only the declining requirements for calcium replacement during CRRT prompted workup for hypercalcemia that lead to identification of significant vertebral fractures and treatment. Declining need for calcium replacement during CRRT should prompt investigation and treatment of disorders of hypercalcemia and metabolic bone disorders in this patient population.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Longitudinal Changes in Bone Turnover Following Withdrawal of RANKL Inhibition (W-179B) - May 11, 2023 - Abstract #ENDO2023ENDO_1337;
Our findings show that rebound decline in BMD has already occurred by the time bone turnover markers used in clinical practice (P1NP and CTX) rise above vehicle levels. A significant overshoot in serum TRAP occurs earlier and prior to bone loss and may better inform sequential therapy following denosumab discontinuation.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
A Tale of Two Calcium Disorders: Hypercalcemia in Pregnancy (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_781;
Cinacalcet is used in primary hyperparathyroidism. Cinacalcet has been safely used in pregnancy in animal studies.In conclusion, hypercalcemia in pregnancy requires prompt diagnosis and treatment with the mainstay acceptable therapies for non PTH mediated hypercalcemia being intravenous fluids and calcitonin.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Ectopic (Penile) Calcification in 1, 25 Vitamin D Induced Hypercalcemia (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_776;
Sarcoidosis of the penis is also very rare and cases in the literature cite either a cutaneous or intraurethral lesion. This case appears unique in the findings of penile calcification palpable on exam and visible on imaging, without any cutaneous manifestations, in the setting of previous though recovered acute renal failure and 1, 25 Vitamin D-mediated hypercalcemia in sarcoidosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Recurrent Hypercalcemia due to 1,25 Dihydroxy Vitamin D elevation of unclear etiology (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_770;
In patients with recurrent hypercalcemia and elevated 1,25 dihydroxy vitamin D levels, a complete work-up for underlying malignancy, granulomatous or other unusual diseases is indicated. Glucocorticoid therapy is the most effective way to control the hypercalcemia related to increased 1,25 dihydroxy vitamin D even in the long-term phase, especially until the main cause of the problem is identified and treated appropriately.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Parathyroid Carcinoma: A Case Report (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_748;
He was started on denosumab 60 mg subcutaneously every 6 months, which was increased to 60mg every month and then 120mg every month to maintain normal calcium levels...Some studies have shown that long term survival is favorable, but recurrences are frequent and patients tend to live a life filled with long-term follow up, multiple laboratory exams and imaging, hospitalizations and frequent reoperations. Mortality is usually due to uncontrollable hypercalcemia, leading to renal failure and cardiac arrhythmias.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Beyond Guidelines: Treatment of Concurrent Osteogenesis Imperfecta and Metastatic Bone Disease (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_211;
She was treated with denosumab 120mg s.c. every 3 months for six total doses and palliative radiation to the pubic ramus...Data for newer agents PTH analogs and romosuzumab are lacking. We present this case to highlight the need for an individualized treatment approach in these patients.
- |||||||||| 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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Rydapt (midostaurin) / Novartis
Journal: Skin and bones: systemic mastocytosis and bone. (Pubmed Central) - May 11, 2023
Treatment of osteoporosis in systemic mastocytosis involves antiresorptive therapy with bisphosphonates and more recently, denosumab. There are limited data on the role of osteoanabolic agents.
- |||||||||| Bmab 1000 (denosumab biosimilar) / Biocon, Yoshindo
Enrollment closed: DEVOTE: Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia (clinicaltrials.gov) - May 10, 2023
P3, N=480, Active, not recruiting,
No abstract available Recruiting --> Active, not recruiting
- |||||||||| Bmab 1000 (denosumab biosimilar) / Biocon, Yoshindo
Enrollment closed: Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia (clinicaltrials.gov) - May 10, 2023
P1, N=190, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Adverse events: Side effects of osteoporosis treatments: how to explain them to patients? (Pubmed Central) - May 7, 2023
Only vertebral fractures after stopping denosumab make this treatment a matter for experienced practitioners. Therefore, knowing the side effects of prescribed treatments and explaining them to patients is essential to promote adherence.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Reimbursement, US reimbursement, Journal, Medicare: Comparability of Osteoporosis Treatment Groups Among Female Medicare Beneficiaries in the United States. (Pubmed Central) - May 7, 2023
Therefore, knowing the side effects of prescribed treatments and explaining them to patients is essential to promote adherence. This retrospective study assessed the comparability of postmenopausal women, treated with osteoporosis medications with various mechanisms of action such as denosumab (receptor activator of nuclear factor ?B ligand [RANKL] inhibitor), zoledronic acid (bisphosphonate derivative), or oral bisphosphonates including alendronate.
- |||||||||| 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.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Prevention of Skeletal-Related Events With Extended-Interval Denosumab: A Review of the Literature. (Pubmed Central) - May 3, 2023
If efficacy is maintained, extending the dosing interval could potentially reduce toxicity, drug cost, and clinic visits compared to every 4-week dosing. At this time, data demonstrating efficacy and safety of extended-interval denosumab remain limited, and the results of the REDUSE trial are eagerly anticipated to help answer remaining questions.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Association between Hyperglycemia and Medication-Related Osteonecrosis of the Jaw (MRONJ). (Pubmed Central) - Apr 28, 2023
Ischemia is a complication of abnormal glucose levels, a possible risk factor for necrosis development. Hence, uncontrolled or poorly regulated plasma glucose levels can significantly increase the risk of jawbone necrosis after invasive dental or oral surgical interventions.
- |||||||||| CMAB807 (denosumab biosimilar) / 3SBio
Trial completion date, Trial primary completion date: Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia (clinicaltrials.gov) - Apr 28, 2023
P3, N=278, Recruiting,
Hence, uncontrolled or poorly regulated plasma glucose levels can significantly increase the risk of jawbone necrosis after invasive dental or oral surgical interventions. Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Jan 2023 --> Oct 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Bone health practices in metastatic prostate cancer (mPCA). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_5511;
Pts with mPCA had high rates of vitamin D and calcium supplementation for OP/P prevention. Denosumab was the most used bone agent in concordance with guidelines for mPCA.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Oncologists (On Demand | Hall A; Poster Bd # 131) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2738;
These findings raise quality-of-care concerns regarding physician-industry financial relationships. Additional work is needed to further explore the causal relationship between payments and non-recommended treatments, and between payments and patient outcomes.
- |||||||||| ATI-2231 / Aclaris
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) - Apr 26, 2023
P1, N=36, Not yet recruiting,
Clinical trial information: NCT02521844. Phase classification: P1/2 --> P1 | N=174 --> 36 | Trial completion date: Oct 2030 --> Feb 2025 | Trial primary completion date: Oct 2030 --> Feb 2025
- |||||||||| Prolia (denosumab) / Amgen
Trial completion date, Trial primary completion date: Study of XGEVA (clinicaltrials.gov) - Apr 25, 2023
P4, N=35, Not yet recruiting,
Phase classification: P1/2 --> P1 | N=174 --> 36 | Trial completion date: Oct 2030 --> Feb 2025 | Trial primary completion date: Oct 2030 --> Feb 2025 Trial completion date: Jul 2027 --> Oct 2027 | Trial primary completion date: Jun 2027 --> Oct 2027
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment closed, Trial completion date: Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND (clinicaltrials.gov) - Apr 21, 2023
P3, N=476, Active, not recruiting,
Therefore, studies investigating disease activity and treatment response should include lesional imaging and patient-reported outcome measures. Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Apr 2025
- |||||||||| AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy's
Enrollment closed: AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - Apr 21, 2023
P=N/A, N=206, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Nov 2024 --> Apr 2025 Recruiting --> Active, not recruiting
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Current Updates in Diagnosis and Treatment of CKD-MBD (Room 1+2) - Apr 15, 2023 - Abstract #KSN2023KSN_81;
While there is now more and better information available to understand CKD-MBD and better drugs to treat CKD patients, it has been observed that focusing solely on correcting phosphate, calcium, vitamin D, and PTH levels is not sufficient to reduce the complications associated with CKD-MBD. Therefore, the development of alternative therapeutic approaches is imperative.
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