Evenity 105mg ( DrugBank: - )

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1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
274	骨形成不全症	1

274. 骨形成不全症

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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

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	EUCTR2017-004972-74-IT (EUCTR)	21/10/2020	21/01/2021	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 - 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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 1	France;Hungary;Greece;Spain;Turkey;Germany;Italy