Romosozumab (DrugBank: Romosozumab)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 1 |
| 274 | 骨形成不全症 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT1041190127 | 10/03/2020 | 10/03/2020 | Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatoid arthritis despite bisphosphonate over a Year | Randomized controlled trial of romosozumab and denosumab for glucocorticoid-induced osteoporosis with inadequate response to bisphosphonate in rheumatoid arthritis patients | Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis | arm Romosozumab-denosumab: romosozumab 210mg s.c. once monthly for 12months, after that, denosumab 60mg s.c. once every 6months for 12months arm Denosumab: denosumab 60mg s.c. once every 6months for 12months after that romosozumab 210mg s.c. once monthly for 12months Arm denosumab, in case denosumab has enough response, based on physician's dicision, denosumab can be continued. all patients: eldecalcitol 0.75microg ram p.o. once a day (Dose reduced to 0.5microg ram once a d ay depending on symptoms) | KOJIMA TOSHIHISA | NULL | Pending | Not applicable | Not applicable | Female | 100 | N/A | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04545554 (ClinicalTrials.gov) | November 16, 2020 | 4/9/2020 | Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin D | Amgen | NULL | Not yet recruiting | 5 Years | 17 Years | All | 16 | Phase 1 | NULL |
| 2 | EUCTR2017-004972-74-HU (EUCTR) | 15/09/2020 | 10/07/2020 | An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis Imperfecta | An Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta | Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births. MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: Romosozumab Product Code: AMG 785 INN or Proposed INN: ROMOSOZUMAB Other descriptive name: AMG 785 | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy |