DDrare: Database of Drug Development for Rare Diseases

Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ACLASTA; AMG 162; AMG 785; ANTI-SCLEROSTIN MONOCLONAL ANTIBODY; Aclasta; Actonel 5mg Film Coated Tablets; Actonel Once a Week 35 mg film-coated tablets; Actonel/Optinate 5mg film-coated tablets; Alendronate; Alendronic acid; Anti-sclerostin monoclonal antibody; BOOST cells; BPS804; Bisphosphonates; Blood sample; Bone marrow transplant; Bonefos; Busulfan; Calcichew tablets; Calcium; Celulas madre mesenquimales troncales adultas alogenicas de médula ósea no expandida; Cyclophosphamide; Cyclosporin; Células mesenquimales troncales adultas alogénicas de médula ósea no expandidas; Células mesenquimales troncales adultas alogénicas de médula ósea no expandidas(ref cruzada PEI nº 12-088); DENOSUMAB; Denosumab; Denosumab - - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand; Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand; Denusomab; Disodium Pamidronate 15mg (15mg strength); Expanded human first trimester fetal liver-derived mesenchymal stem cells; Forsteo; Fresolimumab; GENOTROPIN*1TBF 5,3MG (16UI); H05AA02; High-dose vitamin D (2000 IU per day); Humatrope; Ibandronic acid; Ibandronic acid solution; Mesenchymal Stem Cells; Mesenchymal Stromal Cells; NERIXIA*INFUS IV CONC 2F 100MG; Optinate 5 mg filmcoated tablets; Other: Bone Marrow Cell Transplantation; Other: No active treatment; Other: saline; Pamidronate; Pamidronate (Aredia); Pamidronate sodium; Procedure: Mesenchymal Stem Cell Transplantation; Prolia; REF CRUZADA PEI Nº 12-088; RITUXIMAB; ROMOSOZUMAB; Radiation: Irradiation, Total Body; Risedronate; Risedronate Oral Tablet; Risedronate Sodium; Risedronate sodium; Risedronate sodium (Actonel); Risedronate sodium 2.5mg; Risedronate sodium 5mg; Risedronato sódico 2.5mg; Risedronato sódico 5mg; Risedronic acid; Rituximab; Romosozumab; Setrusumab; Somatropin; Standard-dose vitamin D (400IU per day); Teriparatide; Teriparatide (FORTEO); Teriparatide Pen Injector; VARI; Vitamin D; XGEVA; Xgeva; ZOL446; ZOLEDRONIC ACID; Zoledronic Acid; Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product; Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product.; Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion,generic medicinal product; Zoledronic acid; Zometa; Ácido risedrónico

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

No.

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Intervention

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agemin

Inclusion_
agemax

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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

Phase 1

NULL

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

Phase 1

France;Hungary;Greece;Spain;Turkey;Germany;Italy