274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details


臨床試験数 : 91 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48

  
2 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
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PhaseCountries
1NCT04545554
(ClinicalTrials.gov)
January 21, 20214/9/2020Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis ImperfectaAn Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin DAmgenNULLActive, not recruiting5 Years17 YearsAll25Phase 1United States;Austria;Germany;Greece;Hungary;Italy;Spain;Turkey
2EUCTR2017-004972-74-IT
(EUCTR)
21/10/202021/01/2021An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis ImperfectaAn Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta - NA Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass, and increased bone turnover contributing to osteoporosis, fractures, and other conditions. OI is the most common form of primary osteoporosis in children 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]
Trade Name: Evenity 105mg
Product Name: Romosozumab
Product Code: [AMG 785]
INN or Proposed INN: ROMOSOZUMAB
Trade Name: CALCIUM D3 SANDOZ - 1000 MG + 880 U.I. COMPRESSE EFFERVESCENTI 30 COMPRESSE DIVISIBILI
Product Name: Calcium D3
Product Code: [vitamina D e calcio]
INN or Proposed INN: CALCIO CARBONATO/COLECALCIFEROLO
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy