Denosumab has been approved for the treatment of bone metastases from solid tumors. QL1206 is the first denosumab biosimilar and needs to be compared with denosumab in a phase III trial....
This phase III trial aims to compare the efficacy, safety, and pharmacokinetics between QL1206 and denosumab in patients with bone metastases from solid tumors....
This randomized, double-blind, phase III trial was conducted in 51 centers in China. Patients aged 18-80 years, with solid tumors and bone metastases, and an Eastern Cooperative Oncology Group perform...
From September 2019 to January 2021, in the full analysis set, 717 patients were randomly assigned to receive QL1206 (n = 357) or denosumab (n = 360). Median percentage changes in uNTX/uCr at Week 13 ...
Denosumab biosimilar QL1206 had promising efficacy, tolerable safety, and pharmacokinetics equivalent to denosumab and could benefit patients with bone metastases from solid tumors....
ClinicalTrials.gov Identifier: NCT04550949, retrospectively registered on 16 September, 2020....
Little is known about treatment of osteoporosis with denosumab (Prolia®) in patients with decreased kidney function. The aim of this retrospective case report study was to investigate effects and side...
Since 2012, 75 patients with osteoporosis and decreased kidney function had been treated with denosumab (Prolia®) in the osteoporosis outpatient clinic of the department of endocrinology, Bispebjerg H...
At baseline, the mean estimated glomerular filtration rate (eGFR) was 34 mL/min (range 9-50) and the median age was 85 years (range 45-103). 95% of the patients had had low-energy fractures, and the b...
Treatment with denosumab of osteoporosis in patients with decreased kidney function (eGFR 9-50 mL/min), with normal/high PTH, seems in general to be well tolerated, with improvement of bone and decrea...
The effect of long-term denosumab therapy and of denosumab discontinuation on the cortical bone of the hip regions in dialysis patients has not been studied....
This retrospective study investigated the cortical and trabecular compartments and estimated strength indices of the hip region, obtained using 3D-SHAPER software, after a maximum of 5 years of denosu...
Integral and trabecular volumetric bone mineral densities (BMD) were significantly lower at the start of denosumab therapy than those in 1 year before denosumab initiation. After starting denosumab, a...
The BMD of both cortical and trabecular components in the hip region was significantly higher after starting denosumab therapy. However, these measurements exhibited a trend of declining substantially...
The most appropriate surgical procedure for tertiary hyperparathyroidism is still controversial. Medical management may be considered in those patients with failed previous surgical intervention. Ther...
Erythema nodosum (EN) is the most common clinical presentation of panniculitis, an inflammatory process that affects subcutaneous cellular tissue, characterized by the acute appearance of painful eryt...
Zoledronic acid and denosumab are bone-modifying agents that are clinically important in multiple aspects of bone management for breast cancer patients. These aspects include the prevention of osteopo...
A post-menopausal Caucasian woman sustained an atypical femoral fracture (AFF) after 5-years continuous denosumab for osteoporosis without prior bisphosphonate exposure. This is only the fifth case re...
Denosumab has demonstrated overwhelmingly favourable skeletal benefit/risk profile in managing post-menopausal osteoporosis with up to 10-year exposure in the extension of the pivotal FREEDOM randomis...
We present an 85-year-old Caucasian post-menopausal woman without prior fragility fracture who sustained unilateral atypical femoral fracture after 5-years continuous subcutaneous denosumab for osteop...
X-ray scan demonstrated complete, non-comminuted left proximal femoral shaft fracture meeting radiographic criteria for an atypical femoral fracture. Computed tomography (CT) scan lower limbs revealed...
The patient underwent intramedullary nailing of the femur and denosumab was ceased. This is only the fifth case reported of atypical femoral fracture in a bisphosphonate-naïve patient receiving denosu...
This study evaluated the financial impact of increasing denosumab usage for managing postmenopausal osteoporosis over a 5-year period from the Malaysian healthcare provider's perspective. A gradual mo...
The study aimed to evaluate the budget impact of increasing the uptake of denosumab for the management of postmenopausal osteoporosis in Malaysia....
A Markov budget impact model was developed to estimate the financial impact of osteoporosis treatment. We modelled a scenario in which the uptake of denosumab would increase each year compared with a ...
An increase in denosumab uptake of 8% per year over a 5-year time horizon would result in an additional budget impact, from MYR 0.26 million (USD 0.06 million) in the first year to MYR 3.25 million (U...
From the perspective of a Malaysian MOH healthcare provider, moderately increasing uptake of denosumab would have a minimal additional budget impact, partially offset by savings in fracture treatment ...
Hepatotoxicity is observed due to cyclin-dependent kinase (CDK4/6) inhibitors used to treat hormone receptor-positive metastatic breast cancer. However, it should not be ignored that denosumab may be ...
A 73-year-old female patient with breast cancer with axillary lymph node, adrenal gland and bone metastases was started on ribociclib letrozole and denosumab treatment. Ribociclib treatment was discon...
Despite the discontinuation of ribociclib treatment, other causes of liver toxicity were investigated due to persistence of hepatic transaminases and elevation. Autoimmune hepatitis markers were negat...
Although cases with improvement in liver enzymes have been reported after discontinuation of ribociclib, no improvement in hepatotoxicity was observed in our case. Since the liver biopsy was toxic hep...
We aimed to assess the efficacy and safety of denosumab in postmenopausal women with primary hyperparathyroidism (PHPT)-related osteoporosis and chronic kidney disease (CKD)....
Women over 50 years of age with PHPT or postmenopausal osteoporosis (PMO) were retrospectively recruited into this longitudinal study. These PHPT and PMO groups were further categorized into subgroups...
145 postmenopausal women median age 69 [63;77] were recruited and assigned to one of the subgroups: PHPT patients with CKD (n = 22), PHPT patients without CKD (n = 38), PMO patients with CKD (n = 17) ...
Denosumab treatment was similarly effective at increasing BMD in patients with PHPT and PMO with and without renal insufficiency. The calcium lowering effects of denosumab were most significant in pat...
