主要目的：评估生产场地变更前后的注射用重组人甲状旁腺素（1-84）[rhPTH（1-84），规格：100μg/瓶]在中国健康受试者中单次空腹皮下注射给药100μg的药代动力学相似性。次要目的： 1. 观察生产场地变更前后的注射用重组人甲状旁腺素（1-84）在中国健康受试者中的安全性； 2. 观察生产场地变更前后的注射用重组人甲状旁腺素（1-84）在中国健康受试者中的免疫原性； 3. 观察生产场地变更前后的注射用重组人甲状旁腺素（1-84）在中国健康受试者中单次皮下注射100μg后，血清总钙（白蛋白校正）浓度的变化。

开始日期2023-07-11

申办/合作机构

四川泸州步长生物制药有限公司

CTR20231538 / CompletedN/A

注射用重组人甲状旁腺素（1-84）与Natpar®在中国健康受试者中进行的单中心、随机、开放、单次空腹皮下给药、两制剂、两序列、两周期、交叉的药代动力学和安全性比对研究

主要目的：观察中国健康受试者单次皮下注射试验药注射用重组人甲状旁腺素（1-84）（规格：100μg/瓶；生产厂家：四川泸州步长生物制药有限公司）和参照药重组人甲状旁腺素（1-84）（商品名：Natpar®，规格：50μg/剂；生产厂家：Shire Pharmaceuticals Ireland Limited）后的药代动力学特征，评价两种制剂的药代动力学相似性。次要目的： 1.观察试验药重组人甲状旁腺素（1-84）和参照药Natpar®在中国健康受试者中的安全性； 2.观察试验药重组人甲状旁腺素（1-84）和参照药Natpar®在中国健康受试者中的免疫原性； 3.观察试验药重组人甲状旁腺素（1-84）和参照药Natpar®在中国健康受试者中单次皮下注射50μg后，血清总钙（白蛋白校正）浓度的变化。

开始日期2023-07-04

申办/合作机构

四川泸州步长生物制药有限公司

100 项与重组人甲状旁腺素（1-84）(四川泸州步长生物) 相关的临床结果

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100 项与重组人甲状旁腺素（1-84）(四川泸州步长生物) 相关的转化医学

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100 项与重组人甲状旁腺素（1-84）(四川泸州步长生物) 相关的专利（医药）

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项与重组人甲状旁腺素（1-84）(四川泸州步长生物) 相关的文献（医药）

2019-05-01·The Journal of Clinical Endocrinology & Metabolism2区 · 医学

Efficacy of Pharmacological Therapies for the Prevention of Fractures in Postmenopausal Women: A Network Meta-Analysis

2区 · 医学

Article

作者: Asi, Noor ; Haydour, Qusay ; Benkhadra, Khalid ; Sarigianni, Maria ; Alahdab, Fares ; Wang, Zhen ; Almasri, Jehad ; Mohammed, Khaled ; Barrionuevo, Patricia ; Kapoor, Ekta ; Muthusamy, Kalpana ; Farah, Wigdan ; Murad, Mohammad Hassan ; Al Nofal, Alaa

AbstractBackgroundOsteoporosis and osteopenia are associated with increased fracture incidence in postmenopausal women. We aimed to determine the comparative effectiveness of various available pharmacological therapies.MethodsWe searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ISI Web of Science, and Scopus for randomized controlled trials that enrolled postmenopausal women with primary osteoporosis and evaluated the risk of hip, vertebral, or nonvertebral fractures. A network meta-analysis was conducted using the multivariate random effects method.ResultsWe included 107 trials (193,987 postmenopausal women; mean age, 66 years; 55% white; median follow-up, 28 months). A significant reduction in hip fractures was observed with romosozumab, alendronate, zoledronate, risedronate, denosumab, estrogen with progesterone, and calcium in combination with vitamin D. A significant reduction in nonvertebral fractures was observed with abaloparatide, romosozumab, denosumab, teriparatide, alendronate, risedronate, zoledronate, lasofoxifene, tibolone, estrogen with progesterone, and vitamin D. A significant reduction in vertebral fractures was observed with abaloparatide, teriparatide, parathyroid hormone 1-84, romosozumab, strontium ranelate, denosumab, zoledronate, risedronate, alendronate, ibandronate, raloxifene, bazedoxifene, lasofoxifene, estrogen with progesterone, tibolone, and calcitonin. Teriparatide, abaloparatide, denosumab, and romosozumab were associated with the highest relative risk reductions, whereas ibandronate and selective estrogen receptor modulators had lower efficacy. The evidence for the treatment of fractures with vitamin D and calcium remains limited despite numerous large trials.ConclusionsThis network meta-analysis provides comparative effective estimates for the various available treatments to reduce the risk of fragility fractures in postmenopausal women.

2017-06-01·Journal of Endocrinological Investigation2区 · 医学

The effect of parathyroid hormone (1–84) treatment on serum bone morphogenetic protein 4 and vascular endothelial growth factor in postmenopausal women with established osteoporosis

2区 · 医学

Article

作者: Fabbri, A ; Minisola, S ; Pola, E ; Biamonte, F ; Pepe, J ; Cantatore, F P ; Cipriani, C ; Ferrara, C ; Pascone, R ; Vinicola, V ; Raimo, O

PURPOSETo investigate the effect of 18 months' parathyroid hormone 1-84 (PTH 1-84) treatment on serum levels of bone morphogenetic protein 4 (BMP4) and vascular endothelial growth factor (VEGF), in postmenopausal women with established osteoporosis.METHODSThirty-seven postmenopausal women with osteoporosis (mean age 72.9 ± 8.1 years old) and 23 healthy controls (mean age 68.9 ± 9.9 years old) were enrolled. Patients were treated with daily subcutaneous injections of PTH (1-84) 100 mcg for 18 months, plus calcium 1 gr and vitamin D 800 IU per os daily. Blood samples were taken every 6 months during the study.RESULTSAt baseline, there were no differences considering anthropometric parameters, co-morbidities, current medications used between patients and controls. Mean serum VEGF levels were significantly higher in osteoporotic patients compared to controls (436.7 ± 259.7 vs. 260.3 ± 184.3 pg/ml, p = 0.006), while there were no differences in mean serum values of BMP4 (5.3 ± 1.7 vs. 5.7 ± 1.6 pg/ml, p = 0.40). Serum VEGF levels increased by approximately 20% after 12 months of PTH (1-84) treatment compared to baseline (p = 0.03) and by 22% after 18 months (p = 0.01). A significant increase of 10% in mean serum BMP4 levels was observed after 18 months of PTH (1-84) treatment compared to baseline (p = 0.02). In the control group we found no differences after 18 months compared to baseline in BMP4 (5.7 ± 1.6 vs. 6.0 ± 1.5 pg/ml, p = 0.53) and VEGF (260.3 ± 184.3 vs. 257.4 ± 107.1 pg/ml, p = 0.94).CONCLUSIONSPTH (1-84) treatment increased serum levels of VEGF and BMP4 in postmenopausal women with severe osteoporosis.

2015-12-01·Injury3区 · 医学

Comparative study of the effect of PTH (1–84) and strontium ranelate in an experimental model of atrophic nonunion

3区 · 医学

Article

作者: Garcés Zarzalejo, C ; Alfonso Fernández, A ; Pascual Carra, A ; Mayorga Fernández, M ; Ferreño Blanco, D ; Rodriguez López, T ; Diego Cavia, S ; Pérez Núñez, M I ; Ruiz Martínez, E ; De la Red Gallego, M ; Riancho Moral, J A ; Carrascal Vaquero, I ; Casado de Prado, J A ; Sánchez Crespo, M

This study aimed to set up an experimental model of long bone atrophic nonunion and to explore the potential role of PTH-1-84 (PTH 1-84) and strontium ranelate (SrR). A model of atrophic nonunion was created in Sprague-Dawley rats at the femoral midshaft level. The animals were randomised into four groups. Group A1: control rodents, fracture without bone gap; Group A2: rodents with subtraction osteotomy (non-union model control) treated with saline; Group B: rodents with subtraction osteotomy treated with human-PTH (PTH 1-84); and Group C: rodents with subtraction osteotomy treated with strontium ranelate (SrR). The groups were followed for 12 weeks. X-rays were be obtained at weeks 1, 6 and 12. After sacrificing the animals, we proceeded to the biomechanical study and four point bending tests to evaluate the resistance of the callus and histological study. In second phase, the expression of genes related to osteoblast function was analysed by reverse transcription-quantitative PCR in rats subjected to substraction osteotomy and treated for 2 weeks. The animals were randomised into three groups: Group A2: rodents treated with saline; Group B: rodents treated with PTH 1-84 and Group C: rodents treated with SrR.RESULTSNo significant histological differences were found between animals subjected to subtraction osteotomy and treated with either saline or PTH (p=0.628), but significant difference existed between animals receiving saline or SrR (p=0.005). There were no significant differences in X-ray score between the saline and PTH groups at either 6 or 12 weeks (p=0.33 and 0.36, respectively). On the other hand, better X-ray scores were found in the SrR group (p=0.047 and 0.006 in comparison with saline, at 6 and 12 weeks, respectively). In line with this, biomechanical tests revealed improved results in the SrR group. Gene expression analysis revealed a slightly decreased levels of DKK1, a Wnt pathway inhibitor, in rats treated with SrR.CONCLUSIONSSrR increases has a beneficial effect in this atrophic non-union model in rats. This suggests that it might have a role may have important implications for the potential clinical role in the treatment of fracture nonunion.

100 项与重组人甲状旁腺素（1-84）(四川泸州步长生物) 相关的药物交易

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