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


臨床試験数 : 87 薬物数 : 103 - (DrugBank : 20) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 76

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
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agemax
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PhaseCountries
1NCT05231668
(ClinicalTrials.gov)
March 4, 202231/1/2022Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)A Phase 1b, Single Ascending Dose, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Activity of SAR439459 in Adults With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: SAR439459;Drug: PlaceboSanofiNULLNot yet recruiting18 Years65 YearsAll24Phase 1NULL
2NCT05125809
(ClinicalTrials.gov)
February 21, 20228/11/2021Study to Assess the Efficacy and Safety of Setrusumab in Participants With Osteogenesis ImperfectaA Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis ImperfectaOsteogenesis ImperfectaBiological: Setrusumab;Other: PlaceboUltragenyx Pharmaceutical IncMereo BioPharmaRecruiting5 Years25 YearsAll195Phase 2/Phase 3United States;Australia;Canada;Denmark;Italy;United Kingdom
3EUCTR2017-004972-74-DE
(EUCTR)
20/07/202122/07/2020An 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy
4EUCTR2017-004972-74-GR
(EUCTR)
19/02/202118/12/2020An 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy
5NCT04545554
(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 DAmgenNULLRecruiting5 Years17 YearsAll16Phase 1United States;Germany;Greece;Hungary;Italy;Spain;Turkey
6EUCTR2016-003228-22-NL
(EUCTR)
13/01/202127/11/2020Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study Osteogenesis imperfecta
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: Teriparatide
Product Name: Teriparatide
Trade Name: Zoledronic acid
Product Name: Zoledronic acid
Trade Name: Alendronic acid
Product Name: Alendronic acid
Trade Name: Risedronate sodium
Product Name: Risedronate sodium
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Disodium Pamidronate 15mg (15mg strength)
Product Name: Disodium Pamidronate 15mg (15mg strength)
Trade Name: Prolia
Product Name: Prolia
Trade Name: Bonefos
Product Name: Bonefos
University of EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Ireland;Netherlands;United Kingdom
7EUCTR2018-000550-21-BG
(EUCTR)
01/12/202011/09/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
8EUCTR2017-004972-74-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
9EUCTR2014-000184-40-PL
(EUCTR)
13/10/202015/01/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
10EUCTR2018-000550-21-DE
(EUCTR)
18/09/202020/02/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
11EUCTR2017-004972-74-HU
(EUCTR)
15/09/202010/07/2020An 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy
12EUCTR2018-000550-21-CZ
(EUCTR)
31/03/202014/02/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
13NCT04152551
(ClinicalTrials.gov)
November 2, 201918/10/2019Effects of Bisphosphonates on OI-Related Hearing LossEffects of Bisphosphonates on OI-Related Hearing Loss: A Pilot StudyOsteogenesis ImperfectaDrug: Risedronate Oral TabletHospital for Special Surgery, New YorkThe New York Community Trust;Weill Medical College of Cornell University;Northwell HealthRecruiting6 Years100 YearsAll100Phase 4United States
14NCT04009733
(ClinicalTrials.gov)
October 3, 201928/6/2019Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI StudyEpigenetic Regulation of Osteogenesis Imperfecta Severity : miROI StudyOsteogenesis ImperfectaBiological: Blood sampleHospices Civils de LyonNULLRecruiting18 YearsN/AAll100N/AFrance
15EUCTR2018-000550-21-ES
(EUCTR)
01/10/201905/07/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
16NCT03706482
(ClinicalTrials.gov)
August 12, 20195/10/2018Boost Brittle Bones Before BirthAn Exploratory, Open Label, Multiple Dose, Multicentre Phase I/II Trial Evaluating Safety and Efficacy of Postnatal or Prenatal and Postnatal Intravenous Administration of Allogeneic Expanded Fetal Mesenchymal Stem Cells for the Treatment of Severe Osteogenesis Imperfecta Compared With a Combination of Historical and Untreated Prospective ControlsOsteogenesis ImperfectaBiological: BOOST cellsKarolinska InstitutetKarolinska University Hospital;Great Ormond Street Hospital for Children NHS Foundation Trust;University College, London;Universitätsklinikum Köln;UMC Utrecht;Leiden University Medical Center;Lund UniversityRecruitingN/A18 MonthsAll30Phase 1/Phase 2Sweden
17EUCTR2018-000550-21-IT
(EUCTR)
21/06/201915/06/2021Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - NA Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: [AMG 162]
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany
18NCT04623606
(ClinicalTrials.gov)
May 20, 201918/9/2020Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle BonesExploratory, Open Label, Multiple Dose, Phase I/II Trial Evaluating Safety, Efficacy of Intravenous and Intraosseous Infusion of Allogeneic Fetal Mesenchymal Stem In Treatment of Severe Osteogenesis Imperfecta Compared With Historical and Untreated Prospective ControlsOsteogenesis ImperfectaBiological: BOOST cellsChristian Medical College, Vellore, IndiaMinistry of Science and Technology, India;Vinnova;Karolinska InstitutetRecruiting1 Year8 YearsAll15Phase 1/Phase 2India
19EUCTR2018-000550-21-GB
(EUCTR)
07/03/201917/06/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
20EUCTR2015-003699-60-SE
(EUCTR)
28/09/201823/07/2018Treatment of severe congenital Brittle bone disease after or before and after birth.An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls. Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Product Name: Expanded human first trimester fetal liver-derived mesenchymal stem cells
Product Code: BOOST cells
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
210 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
21NCT03638128
(ClinicalTrials.gov)
July 26, 201821/6/2018Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)Drug: Denosumab;Other: No treatment;Drug: Alternative osteoporosis medicationsAmgenNULLActive, not recruiting5 Years20 YearsAll75Phase 3United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom
22EUCTR2018-000550-21-HU
(EUCTR)
06/07/201810/05/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
23JPRN-UMIN000031290
2018/05/3001/04/2018Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study.Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study. - Efficacy of pamidronate for adult osteogenesis imperfecta Osteogenesis imperfectaPamidronate disodium intervenous for drip use; 15mg/day (available up to 30mg/day), 1 infection/day x 3 dats, every 4 months, total 16 months.Kobe University HospitalNULLRecruiting20years-oldNot applicableMale and Female10Not applicableJapan
24NCT03064074
(ClinicalTrials.gov)
November 15, 201713/10/2016Safety of Fresolimumab in the Treatment of Osteogenesis ImperfectaMulticenter Study to Evaluate Safety of Fresolimumab in Adults With Moderate-to-severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: FresolimumabBaylor College of MedicineGenzyme, a Sanofi Company;Oregon Health and Science UniversityRecruiting18 YearsN/AAll16Phase 1United States
25NCT03216486
(ClinicalTrials.gov)
October 31, 201712/7/2017An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaA Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: BPS804Mereo BioPharmaICON Clinical ResearchWithdrawn18 YearsN/AAll0Phase 2United States
26NCT03118570
(ClinicalTrials.gov)
September 11, 20173/4/2017A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804).Osteogenesis Imperfecta, Type I;Osteogenesis Imperfecta Type III;Osteogenesis Imperfecta Type IVDrug: BPS804Ultragenyx Pharmaceutical IncNULLCompleted18 Years75 YearsAll112Phase 2United States;Canada;Denmark;France;United Kingdom
27EUCTR2016-005096-27-GB
(EUCTR)
25/08/201719/02/2018A study of test product setrusumab in adults with brittle bone syndrome.A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). Osteogenesis imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: setrusumab
Product Code: BPS804
INN or Proposed INN: setrusumab
Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY
Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product
Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product.
INN or Proposed INN: ZOLEDRONIC ACID
Mereo Biopharma 3 Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Denmark;United Kingdom
28EUCTR2016-005096-27-FR
(EUCTR)
24/07/201707/02/2019A study of test product BPS804 compared to placebo in adults with brittle bone syndromeA Phase 2b, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with BPS804. Osteogenesis imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BPS804
INN or Proposed INN: Not established
Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY
Mereo Biopharma 3 Ltd.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;France;Canada;Denmark;United Kingdom
29EUCTR2016-005096-27-DK
(EUCTR)
23/06/201724/03/2017A study of test product setrusumab in adults with brittle bone syndrome.A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). Osteogenesis imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: setrusumab
Product Code: BPS804
INN or Proposed INN: setrusumab
Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY
Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion,generic medicinal product
Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product.
INN or Proposed INN: ZOLEDRONIC ACID
Mereo BioPharma 3 Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;France;Canada;Denmark;United Kingdom
30EUCTR2016-003228-22-IE
(EUCTR)
22/06/201703/11/2016Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study Osteogenesis imperfecta
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: Teriparatide
Product Name: Teriparatide
Trade Name: Zoledronic acid
Product Name: Zoledronic acid
Trade Name: Alendronic acid
Product Name: Alendronic acid
Trade Name: Risedronate sodium
Product Name: Risedronate sodium
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Disodium Pamidronate 15mg (15mg strength)
Product Name: Disodium Pamidronate 15mg (15mg strength)
Trade Name: Prolia
Product Name: Prolia
Trade Name: Clasteon
Product Name: Clasteon
Trade Name: Calcichew D3
Product Name: Calcichew D3
Trade Name: Fultium-D3 800IU capsules
Product Name: Fultium-D3 800IU capsules
Trade Name: Prolia
Product Name: Prolia
University of EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Ireland;Netherlands;United Kingdom
31NCT03169192
(ClinicalTrials.gov)
June 1, 201725/5/2017Diagnosis of Osteogenesis Imperfecta in ChildrenMolecular Genetic Study of Suspected Cases of Osteogenesis Imperfecta Attending Assiut University Children HospitalBone Disease, MetabolicDrug: Zoledronic AcidAssiut UniversityNULLNot yet recruiting1 Month18 YearsAll40N/AEgypt
32NCT03208582
(ClinicalTrials.gov)
April 1, 201723/5/2017Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?Osteogenesis ImperfectaDrug: Risedronate Sodium;Dietary Supplement: Calcichew tabletsSheffield Children's NHS Foundation TrustNULLCompleted4 Years16 YearsAll13Phase 2United Kingdom
33EUCTR2016-003606-14-GB
(EUCTR)
31/01/201717/10/2016Brittle bones - do they react normally after treatment with bisphosphonates?Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta? - BAMES study Osteogenesis Imperfecta
MedDRA version: 19.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Actonel 5mg Film Coated Tablets
Product Name: Actonel 5mg Film Coated Tablets
INN or Proposed INN: Risedronate Sodium
Trade Name: Actonel Once a Week 35 mg film-coated tablets
Product Name: Actonel Once a Week 35 mg film-coated tablets
INN or Proposed INN: Risedronate Sodium
Sheffield Children's NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
15Phase 2United Kingdom
34EUCTR2016-003228-22-GB
(EUCTR)
14/12/201619/10/2016Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acidTreatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid - TOPaZ study Osteogenesis imperfecta
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: Teriparatide
Product Name: Teriparatide
Trade Name: Zoledronic acid
Product Name: Zoledronic acid
Trade Name: Alendronic acid
Product Name: Alendronic acid
Trade Name: Risedronate sodium
Product Name: Risedronate sodium
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Ibandronic acid
Product Name: Ibandronic acid
Trade Name: Disodium Pamidronate 15mg (15mg strength)
Product Name: Disodium Pamidronate 15mg (15mg strength)
Trade Name: Prolia
Product Name: Prolia
Trade Name: Bonefos
Product Name: Bonefos
University of EdinburghNHS LothianAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
380Phase 4Ireland;United Kingdom
35NCT03735537
(ClinicalTrials.gov)
November 1, 20169/8/2018Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidTreatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidOsteogenesis ImperfectaDrug: Teriparatide Pen Injector;Drug: Zoledronic AcidUniversity of EdinburghNHS LothianRecruiting18 YearsN/AAll380Phase 4Ireland;United Kingdom
36EUCTR2015-002622-39-IT
(EUCTR)
18/11/201527/05/2021Experimental Study Protocol on Treatment with plasma transfusions in Patients affected by type VI Osteogenesis ImperfectaExperimental Study Protocol on Treatment with plasma transfusions in Patients affected by type VI Osteogenesis Imperfecta - Experimental Study Protocol on Treatment with plasma transfusions in Patients affected by type VI Os type VI Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: PLASMASAFE - SOLUZIONE PER INFUSIONE 1 SACCA DA 200 ML
Product Name: PLASMASAFE
INN or Proposed INN: 00244301
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONANULLNot RecruitingFemale: yes
Male: yes
10Phase 2Italy
37NCT02352753
(ClinicalTrials.gov)
June 24, 201528/1/2015Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OITo Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OIOsteogenesis ImperfectaDrug: DenosumabAmgenNULLActive, not recruiting2 Years17 YearsAll153Phase 3United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic
38EUCTR2014-000184-40-BE
(EUCTR)
22/05/201523/02/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
39EUCTR2014-000184-40-GB
(EUCTR)
30/01/201526/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom
40EUCTR2014-000184-40-DE
(EUCTR)
29/12/201422/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
41EUCTR2014-000184-40-ES
(EUCTR)
19/10/201401/09/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
42EUCTR2014-000184-40-HU
(EUCTR)
18/10/201429/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 19.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
43EUCTR2014-000184-40-CZ
(EUCTR)
11/09/201412/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
44NCT02172885
(ClinicalTrials.gov)
April 201412/6/2014Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis ImperfectaMesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis ImperfectaOsteogenesis ImperfectaBiological: Mesenchymal Stem CellsHospital de CrucesHospital Universitario Getafe;Hospital Infantil Universitario Niño Jesús, Madrid, SpainCompleted6 Months12 YearsAll2Phase 1Spain
45EUCTR2012-002553-38-ES
(EUCTR)
09/08/201309/04/2013Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfectaMesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta - TERCELOI Osteogenesis imperfecta (OI) is a rare genetic disorder with increased bone fragility of varying severity. In the majority of patients the disease is caused by mutations in collagen type I. Severe OI is characterized by osteopenia, frequent fractures, progressive deformity, short stature, loss of mobility, chronic pain and can lead to premature death. At present a cure does not exist.;Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]Product Name: celulas madre mesenquimales troncales adultas alogenicas de médula ósea no expandida
Product Code: REF CRUZADA PEI Nº 12-088
INN or Proposed INN: células mesenquimales troncales adultas alogénicas de médula ósea no expandidas
Other descriptive name: células mesenquimales troncales adultas alogénicas de médula ósea no expandidas(ref cruzada PEI nº 12-088)
Itziar Astigarraga AguirreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
46NCT04115774
(ClinicalTrials.gov)
June 28, 20132/10/2019Registry of Osteogenesis ImperfectaRegistry of Osteogenesis Imperfecta That Collects Clinical, Functional, Genetic, Genealogical, Imaging, Surgical, Quality of Life Data. Data Are Linked to Patients Biological SampleOsteogenesis ImperfectaDrug: bisphosphonatesLuca SangiorgiNULLRecruitingN/AN/AAll5000Italy
47JPRN-UMIN000010615
2013/04/3030/04/2013Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) - Alendronate infusion for osteogenesis imperfecta osteogenesis imperfectaEighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient's BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient's BMD does not reach to the normal range for age, alendronate will be continued for another 6 months.Tohoku University School of Medicine, Department of PediatricsNULLComplete: follow-up continuingNot applicable15years-oldMale and Female10Not applicableJapan
48EUCTR2012-002887-29-DE
(EUCTR)
13/02/201307/11/2012New therapeutic approach in OI with the antibody DenosumabTranslational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK In this study we will evaluate the efficacy of Denosumab in children with Osteogenesis imperfecta. Subjects will be treated every 12 weeks over 36 weeks with Denosumab 1mg/kg body weight s.c.. Efficacy will be evaluated by DXA measurements of the spine for bone mineral density.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Prolia
Product Name: Denusomab
INN or Proposed INN: DENOSUMAB
Other descriptive name: DENOSUMAB
University of CologneNULLNot RecruitingFemale: yes
Male: yes
Germany
49NCT01799798
(ClinicalTrials.gov)
February 201314/2/2013Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody DenosumabTRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMABOsteogenesis ImperfectaDrug: DenosumabUniversity of CologneNULLCompleted5 Years11 YearsBoth10Phase 2Germany
50EUCTR2011-000745-21-BE
(EUCTR)
10/12/201218/09/2012An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfectaAn international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta - SHC - INFOI Children suffering from severe Osteogenesis Imperfecta
MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ACLASTA
Product Name: zoledronic acid
INN or Proposed INN: RITUXIMAB
Schriners Hospitals for ChildrenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15United States;Canada;Belgium
51NCT01679080
(ClinicalTrials.gov)
November 201216/8/2012The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaThe Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic acid;Drug: Teriparatide;Other: No active treatmentUniversity of AarhusNULLTerminated22 Years70 YearsAll9Phase 2Denmark
52NCT01713231
(ClinicalTrials.gov)
September 201221/10/2012Effect of High-Dose Vitamin D on Bone Density in Osteogenesis ImperfectaEffect of High-Dose Vitamin D on Bone Density in Osteogenesis ImperfectaOsteogenesis ImperfectaDietary Supplement: standard-dose vitamin D (400IU per day);Dietary Supplement: high-dose vitamin D (2000 IU per day)Louis-Nicolas Veilleux Ph.D.NULLCompleted6 Years19 YearsBoth60Phase 4Canada
53EUCTR2011-001465-41-DE
(EUCTR)
23/01/201209/08/2011Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfectaA randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NA Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen.
MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: NA
Product Code: BPS804
INN or Proposed INN: NA
Other descriptive name: Anti-sclerostin monoclonal antibody
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15Canada;Germany
54EUCTR2011-002811-27-DK
(EUCTR)
07/11/201104/11/2011The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis ImperfectaThe Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatment Osteogenesis imperfecta;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Forsteo
Product Code: H05AA02
Trade Name: Aclasta
Bente Langdahl, consultant, ass. professor, PhD, DMScNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Denmark
55EUCTR2011-001465-41-BE
(EUCTR)
20/07/201123/05/2011Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfectaA randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NA Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen.
MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: NA
Product Code: BPS804
INN or Proposed INN: NA
Other descriptive name: Anti-sclerostin monoclonal antibody
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15Phase 1;Phase 2Canada;Belgium;Germany
56NCT01417091
(ClinicalTrials.gov)
June 20114/8/2011Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis ImperfectaA Randomized, Open Label Intra-patient Dose Escalation Study With an Untreated Reference Group to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Infusions of BPS804 in Adults With Moderate Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: BPS804Ultragenyx Pharmaceutical IncNULLCompleted18 Years75 YearsAll10Phase 2United States;Belgium;Canada;Germany
57NCT01061099
(ClinicalTrials.gov)
February 20101/2/2010Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis ImperfectaA Pilot Study to Assess the Safety and Feasibility of Repeated Infusions of Mesenchymal Stromal Cells (MSC) in Children With Osteogenesis ImperfectaOsteogenesis Imperfecta Type II;Osteogenesis Imperfecta Type IIIBiological: Mesenchymal Stromal CellsNationwide Children's HospitalNULLCompletedN/A19 YearsBoth5Phase 1United States
58NCT00982124
(ClinicalTrials.gov)
October 200721/9/2009An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaAn International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidShriners Hospitals for ChildrenNovartisCompletedN/A12 MonthsBoth14Phase 3Canada
59NCT00655681
(ClinicalTrials.gov)
September 20074/4/2008Prevention of Post Operative Bone Loss in ChildrenPrevention of Post Operative Bone Loss in ChildrenOsteoporosis;Cerebral Palsy;Spina Bifida;Osteopenia;Osteogenesis ImperfectaDrug: pamidronate;Other: salineUniversity of New MexicoThrasher Research FundCompleted4 Years18 YearsBoth24N/AUnited States
60NCT02303873
(ClinicalTrials.gov)
March 200719/11/2014Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis ImperfectaEfficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective StudyOsteogenesis ImperfectaDrug: AlendronatePeking Union Medical College HospitalNational Natural Science Foundation of ChinaCompletedN/A18 YearsBoth99Phase 4NULL
61EUCTR2004-000485-13-DK
(EUCTR)
29/01/200729/11/2006A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISEA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE Osteogenesis Imperfecta
MedDRA version: 8.1;Level: LLT;Classification code 10031243;Term: Osteogenesis imperfecta
Product Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Trade Name: Optinate 5 mg filmcoated tablets
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
62EUCTR2004-000485-13-CZ
(EUCTR)
04/10/200625/08/2006A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISEA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE Osteogenesis ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
63EUCTR2004-000485-13-ES
(EUCTR)
27/08/200627/06/2006Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico y de grupos paralelos de un año de duración, seguido de 2 años de tratamiento abierto para determinar la seguridad y eficacia de Risedronato diario 2,5 mg o 5,0 mg administrado oralmente en niños ³ 4 a < 16 años con osteogénesis imperfecta. - POISEEstudio aleatorizado, doble ciego, controlado con placebo, multicéntrico y de grupos paralelos de un año de duración, seguido de 2 años de tratamiento abierto para determinar la seguridad y eficacia de Risedronato diario 2,5 mg o 5,0 mg administrado oralmente en niños ³ 4 a < 16 años con osteogénesis imperfecta. - POISE Osteogenesis ImperfectaProduct Name: risedronato sódico 2.5mg
INN or Proposed INN: ácido risedrónico
Product Name: Risedronato sódico 5mg
INN or Proposed INN: ácido risedrónico
Procter & Gamble LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
64EUCTR2004-000485-13-HU
(EUCTR)
25/08/200614/07/2006A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISEA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE Osteogenesis ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Finland;Hungary;Czech Republic;Denmark;Spain
65EUCTR2004-000485-13-BE
(EUCTR)
22/08/200630/05/2006A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISEA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE Osteogenesis ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Czech Republic;Hungary;Finland;Spain;Belgium;Denmark
66EUCTR2004-000485-13-FI
(EUCTR)
28/03/200610/02/2006A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISEA Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE Osteogenesis ImperfectaProduct Name: risedronate sodium 2.5mg
INN or Proposed INN: risedronic acid
Trade Name: Actonel/Optinate 5mg film-coated tablets
Product Name: Risedronate sodium 5mg
INN or Proposed INN: risedronic acid
Procter & Gamble LtdNULLNot RecruitingFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
67EUCTR2004-001666-40-GB
(EUCTR)
14/06/200513/05/2005An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202EAn international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E Osteogenesis ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Hungary;United Kingdom
68NCT00131469
(ClinicalTrials.gov)
June 200516/8/2005Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis ImperfectaA Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)Osteogenesis ImperfectaDrug: Teriparatide (FORTEO);Drug: PlacebosOregon Health and Science UniversityEli Lilly and Company;Osteogenesis Imperfecta Foundation;National Institutes of Health (NIH);National Center for Research Resources (NCRR)Completed18 Years85 YearsAll79Phase 4United States
69EUCTR2004-005275-42-IT
(EUCTR)
21/03/200523/01/2008Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis ImperfectaStudy on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 6.1;Level: SOC;Classification code 10010331
Trade Name: GENOTROPIN*1TBF 5,3MG (16UI)
INN or Proposed INN: Somatropin
Trade Name: NERIXIA*INFUS IV CONC 2F 100MG
INN or Proposed INN: VARI
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONANULLNot RecruitingFemale: yes
Male: yes
Italy
70EUCTR2004-001666-40-HU
(EUCTR)
01/02/200525/11/2004An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202EAn international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E Osteogenesis ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Hungary;United Kingdom
71NCT00106028
(ClinicalTrials.gov)
November 200418/3/2005Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenSafety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenOsteogenesis ImperfectaDrug: risedronate sodium (Actonel);Drug: PlaceboWarner ChilcottNULLCompleted4 Years15 YearsAll143Phase 3United States;Australia;Belgium;Chile;Czech Republic;Finland;Germany;Hungary;Italy;Poland;South Africa;Spain;United Kingdom
72NCT00131118
(ClinicalTrials.gov)
July 200415/8/2005Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaEfficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNULLCompleted1 Year17 YearsAll127Phase 2United States
73NCT00187018
(ClinicalTrials.gov)
March 200412/9/2005Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot StudyMarrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot StudyOsteogenesis ImperfectaBiological: Bone marrow transplantSt. Jude Children's Research HospitalNULLCompletedN/AN/ABoth9N/AUnited States
74NCT00063479
(ClinicalTrials.gov)
June 200327/6/2003Bisphosphonate Treatment of Osteogenesis ImperfectaBisphosphonate Treatment of Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNULLCompleted3 Months17 YearsAll158Phase 2United States;Germany
75NCT00005901
(ClinicalTrials.gov)
June 20006/6/2000Pamidronate to Treat Osteogenesis Imperfecta in ChildrenA Trial of Pamidronate in Children With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Pamidronate (Aredia)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institutes of Health Clinical Center (CC)CompletedN/A16 YearsAll34Phase 3United States;Canada
76NCT00159419
(ClinicalTrials.gov)
August 19997/9/2005Bisphosphonate Therapy for Osteogenesis ImperfectaBisphosphonate Therapy for Osteogenesis ImperfectaOsteogenesis Imperfecta;Osteoporosis;Paget Disease of BoneDrug: Alendronate;Drug: PamidronateIndiana University School of MedicineNULLCompleted3 Years21 YearsAll18Phase 4United States
77NCT00705120
(ClinicalTrials.gov)
November 199523/6/2008Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationTreatment of Severe (Types II and III) Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationOsteogenesis ImperfectaOther: Bone Marrow Cell Transplantation;Radiation: Irradiation, Total Body;Drug: Cyclophosphamide;Drug: Cyclosporin;Procedure: Mesenchymal Stem Cell Transplantation;Drug: BusulfanSt. Jude Children's Research HospitalNULLCompleted3 YearsN/ABoth9Phase 1United States
78NCT00001305
(ClinicalTrials.gov)
November 5, 19913/11/1999Growth Hormone Therapy in Osteogenesis ImperfectaStudies of Growth Deficiency and Growth Hormone Treatment in Children With Osteogenesis Imperfecta Types III and IVOsteogenesis ImperfectaDrug: HumatropeEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted3 Years16 YearsAll42Phase 3United States
79EUCTR2014-000184-40-FR
(EUCTR)
18/06/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNA Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
80EUCTR2018-000550-21-PL
(EUCTR)
16/10/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
81EUCTR2004-001666-40-BE
(EUCTR)
05/09/2005An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202EAn international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E Osteogenesis ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2Hungary;Belgium;United Kingdom
82EUCTR2014-000184-40-IT
(EUCTR)
15/06/2021Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta - Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in OSTEOGENESIS IMPERFECTA
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA - 120 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 1.7 ML 4 FLACONCINI
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: DENOSUMAB
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
83EUCTR2015-003539-37-Outside-EU/EEA
(EUCTR)
07/03/2016Bisphosphonate Treatment of Osteogenesis ImperfectaAn international, multicenter, randomized, open-label, parallel efficacy, and safety trial of intravenous zoledronic acid compared to intravenous pamidronate in children with severe osteogenesis imperfect. Osteogenesis Imperfecta;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: ZometaNovartisNULLNAFemale: yes
Male: yes
158United States
84EUCTR2014-000184-40-Outside-EU/EEA
(EUCTR)
26/11/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: denosumab - - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNAFemale: yes
Male: yes
150United States;Australia;Canada
85EUCTR2014-000184-40-BG
(EUCTR)
05/12/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
86EUCTR2018-000550-21-FR
(EUCTR)
27/07/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNAFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
87EUCTR2018-000550-21-BE
(EUCTR)
14/01/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNAFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany