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. | 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 | NCT05231668 (ClinicalTrials.gov) | March 4, 2022 | 31/1/2022 | Single 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 Imperfecta | Osteogenesis Imperfecta | Drug: SAR439459;Drug: Placebo | Sanofi | NULL | Not yet recruiting | 18 Years | 65 Years | All | 24 | Phase 1 | NULL |
| 2 | NCT05125809 (ClinicalTrials.gov) | February 21, 2022 | 8/11/2021 | Study to Assess the Efficacy and Safety of Setrusumab in Participants With Osteogenesis Imperfecta | A Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Biological: Setrusumab;Other: Placebo | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Recruiting | 5 Years | 25 Years | All | 195 | Phase 2/Phase 3 | United States;Australia;Canada;Denmark;Italy;United Kingdom |
| 3 | EUCTR2017-004972-74-DE (EUCTR) | 20/07/2021 | 22/07/2020 | 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 | 24 | Phase 1 | France;Hungary;Greece;Spain;Turkey;Germany;Italy | ||
| 4 | EUCTR2017-004972-74-GR (EUCTR) | 19/02/2021 | 18/12/2020 | 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 | ||
| 5 | NCT04545554 (ClinicalTrials.gov) | January 21, 2021 | 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 | Recruiting | 5 Years | 17 Years | All | 16 | Phase 1 | United States;Germany;Greece;Hungary;Italy;Spain;Turkey |
| 6 | EUCTR2016-003228-22-NL (EUCTR) | 13/01/2021 | 27/11/2020 | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid | Treatment 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 Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 7 | EUCTR2018-000550-21-BG (EUCTR) | 01/12/2020 | 11/09/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 8 | 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 | ||
| 9 | EUCTR2014-000184-40-PL (EUCTR) | 13/10/2020 | 15/01/2015 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||
| 10 | EUCTR2018-000550-21-DE (EUCTR) | 18/09/2020 | 20/02/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 11 | 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 | ||
| 12 | EUCTR2018-000550-21-CZ (EUCTR) | 31/03/2020 | 14/02/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 13 | NCT04152551 (ClinicalTrials.gov) | November 2, 2019 | 18/10/2019 | Effects of Bisphosphonates on OI-Related Hearing Loss | Effects of Bisphosphonates on OI-Related Hearing Loss: A Pilot Study | Osteogenesis Imperfecta | Drug: Risedronate Oral Tablet | Hospital for Special Surgery, New York | The New York Community Trust;Weill Medical College of Cornell University;Northwell Health | Recruiting | 6 Years | 100 Years | All | 100 | Phase 4 | United States |
| 14 | NCT04009733 (ClinicalTrials.gov) | October 3, 2019 | 28/6/2019 | Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study | Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study | Osteogenesis Imperfecta | Biological: Blood sample | Hospices Civils de Lyon | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 15 | EUCTR2018-000550-21-ES (EUCTR) | 01/10/2019 | 05/07/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 16 | NCT03706482 (ClinicalTrials.gov) | August 12, 2019 | 5/10/2018 | Boost Brittle Bones Before 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 | Osteogenesis Imperfecta | Biological: BOOST cells | Karolinska Institutet | Karolinska University Hospital;Great Ormond Street Hospital for Children NHS Foundation Trust;University College, London;Universitätsklinikum Köln;UMC Utrecht;Leiden University Medical Center;Lund University | Recruiting | N/A | 18 Months | All | 30 | Phase 1/Phase 2 | Sweden |
| 17 | EUCTR2018-000550-21-IT (EUCTR) | 21/06/2019 | 15/06/2021 | Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfecta | Multicenter, 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany | ||
| 18 | NCT04623606 (ClinicalTrials.gov) | May 20, 2019 | 18/9/2020 | Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones | Exploratory, 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 Controls | Osteogenesis Imperfecta | Biological: BOOST cells | Christian Medical College, Vellore, India | Ministry of Science and Technology, India;Vinnova;Karolinska Institutet | Recruiting | 1 Year | 8 Years | All | 15 | Phase 1/Phase 2 | India |
| 19 | EUCTR2018-000550-21-GB (EUCTR) | 07/03/2019 | 17/06/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 20 | EUCTR2015-003699-60-SE (EUCTR) | 28/09/2018 | 23/07/2018 | Treatment 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 Institutet | NULL | Authorised-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): no | Sweden | ||
| 21 | NCT03638128 (ClinicalTrials.gov) | July 26, 2018 | 21/6/2018 | Multicenter, 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 | Multicenter, 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) | Drug: Denosumab;Other: No treatment;Drug: Alternative osteoporosis medications | Amgen | NULL | Active, not recruiting | 5 Years | 20 Years | All | 75 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom |
| 22 | EUCTR2018-000550-21-HU (EUCTR) | 06/07/2018 | 10/05/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 23 | JPRN-UMIN000031290 | 2018/05/30 | 01/04/2018 | Efficacy 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 imperfecta | Pamidronate 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 Hospital | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 24 | NCT03064074 (ClinicalTrials.gov) | November 15, 2017 | 13/10/2016 | Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta | Multicenter Study to Evaluate Safety of Fresolimumab in Adults With Moderate-to-severe Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Fresolimumab | Baylor College of Medicine | Genzyme, a Sanofi Company;Oregon Health and Science University | Recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 25 | NCT03216486 (ClinicalTrials.gov) | October 31, 2017 | 12/7/2017 | An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta | A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: BPS804 | Mereo BioPharma | ICON Clinical Research | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 26 | NCT03118570 (ClinicalTrials.gov) | September 11, 2017 | 3/4/2017 | A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 | Protocol 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 IV | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Canada;Denmark;France;United Kingdom |
| 27 | EUCTR2016-005096-27-GB (EUCTR) | 25/08/2017 | 19/02/2018 | A 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. | NULL | Authorised-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): no | France;United States;Canada;Denmark;United Kingdom | ||
| 28 | EUCTR2016-005096-27-FR (EUCTR) | 24/07/2017 | 07/02/2019 | A study of test product BPS804 compared to placebo in adults with brittle bone syndrome | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;France;Canada;Denmark;United Kingdom | ||
| 29 | EUCTR2016-005096-27-DK (EUCTR) | 23/06/2017 | 24/03/2017 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Canada;Denmark;United Kingdom | ||
| 30 | EUCTR2016-003228-22-IE (EUCTR) | 22/06/2017 | 03/11/2016 | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid | Treatment 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 Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;Netherlands;United Kingdom | ||
| 31 | NCT03169192 (ClinicalTrials.gov) | June 1, 2017 | 25/5/2017 | Diagnosis of Osteogenesis Imperfecta in Children | Molecular Genetic Study of Suspected Cases of Osteogenesis Imperfecta Attending Assiut University Children Hospital | Bone Disease, Metabolic | Drug: Zoledronic Acid | Assiut University | NULL | Not yet recruiting | 1 Month | 18 Years | All | 40 | N/A | Egypt |
| 32 | NCT03208582 (ClinicalTrials.gov) | April 1, 2017 | 23/5/2017 | Do 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 Imperfecta | Drug: Risedronate Sodium;Dietary Supplement: Calcichew tablets | Sheffield Children's NHS Foundation Trust | NULL | Completed | 4 Years | 16 Years | All | 13 | Phase 2 | United Kingdom |
| 33 | EUCTR2016-003606-14-GB (EUCTR) | 31/01/2017 | 17/10/2016 | Brittle 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | United Kingdom | ||
| 34 | EUCTR2016-003228-22-GB (EUCTR) | 14/12/2016 | 19/10/2016 | Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid | Treatment 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 Edinburgh | NHS Lothian | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Ireland;United Kingdom | ||
| 35 | NCT03735537 (ClinicalTrials.gov) | November 1, 2016 | 9/8/2018 | Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid | Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid | Osteogenesis Imperfecta | Drug: Teriparatide Pen Injector;Drug: Zoledronic Acid | University of Edinburgh | NHS Lothian | Recruiting | 18 Years | N/A | All | 380 | Phase 4 | Ireland;United Kingdom |
| 36 | EUCTR2015-002622-39-IT (EUCTR) | 18/11/2015 | 27/05/2021 | Experimental 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 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 VERONA | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Italy | ||
| 37 | NCT02352753 (ClinicalTrials.gov) | June 24, 2015 | 28/1/2015 | Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI | To 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 OI | Osteogenesis Imperfecta | Drug: Denosumab | Amgen | NULL | Active, not recruiting | 2 Years | 17 Years | All | 153 | Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic |
| 38 | EUCTR2014-000184-40-BE (EUCTR) | 22/05/2015 | 23/02/2015 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 39 | EUCTR2014-000184-40-GB (EUCTR) | 30/01/2015 | 26/08/2014 | Study 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom | ||
| 40 | EUCTR2014-000184-40-DE (EUCTR) | 29/12/2014 | 22/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | ||
| 41 | EUCTR2014-000184-40-ES (EUCTR) | 19/10/2014 | 01/09/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||
| 42 | EUCTR2014-000184-40-HU (EUCTR) | 18/10/2014 | 29/08/2014 | Study 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||
| 43 | EUCTR2014-000184-40-CZ (EUCTR) | 11/09/2014 | 12/08/2014 | Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta | Prospective, 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | ||
| 44 | NCT02172885 (ClinicalTrials.gov) | April 2014 | 12/6/2014 | Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis Imperfecta | Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis Imperfecta | Osteogenesis Imperfecta | Biological: Mesenchymal Stem Cells | Hospital de Cruces | Hospital Universitario Getafe;Hospital Infantil Universitario Niño Jesús, Madrid, Spain | Completed | 6 Months | 12 Years | All | 2 | Phase 1 | Spain |
| 45 | EUCTR2012-002553-38-ES (EUCTR) | 09/08/2013 | 09/04/2013 | Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta | Mesenchymal 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 Aguirre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 46 | NCT04115774 (ClinicalTrials.gov) | June 28, 2013 | 2/10/2019 | Registry of Osteogenesis Imperfecta | Registry of Osteogenesis Imperfecta That Collects Clinical, Functional, Genetic, Genealogical, Imaging, Surgical, Quality of Life Data. Data Are Linked to Patients Biological Sample | Osteogenesis Imperfecta | Drug: bisphosphonates | Luca Sangiorgi | NULL | Recruiting | N/A | N/A | All | 5000 | Italy | |
| 47 | JPRN-UMIN000010615 | 2013/04/30 | 30/04/2013 | Clinical 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 imperfecta | Eighteen 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 Pediatrics | NULL | Complete: follow-up continuing | Not applicable | 15years-old | Male and Female | 10 | Not applicable | Japan |
| 48 | EUCTR2012-002887-29-DE (EUCTR) | 13/02/2013 | 07/11/2012 | New therapeutic approach in OI with the antibody Denosumab | Translational 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 Cologne | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 49 | NCT01799798 (ClinicalTrials.gov) | February 2013 | 14/2/2013 | Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab | TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB | Osteogenesis Imperfecta | Drug: Denosumab | University of Cologne | NULL | Completed | 5 Years | 11 Years | Both | 10 | Phase 2 | Germany |
| 50 | EUCTR2011-000745-21-BE (EUCTR) | 10/12/2012 | 18/09/2012 | An international, multicenter, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta | An 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 Children | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United States;Canada;Belgium | |||
| 51 | NCT01679080 (ClinicalTrials.gov) | November 2012 | 16/8/2012 | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta | The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic acid;Drug: Teriparatide;Other: No active treatment | University of Aarhus | NULL | Terminated | 22 Years | 70 Years | All | 9 | Phase 2 | Denmark |
| 52 | NCT01713231 (ClinicalTrials.gov) | September 2012 | 21/10/2012 | Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta | Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta | Osteogenesis Imperfecta | Dietary Supplement: standard-dose vitamin D (400IU per day);Dietary Supplement: high-dose vitamin D (2000 IU per day) | Louis-Nicolas Veilleux Ph.D. | NULL | Completed | 6 Years | 19 Years | Both | 60 | Phase 4 | Canada |
| 53 | EUCTR2011-001465-41-DE (EUCTR) | 23/01/2012 | 09/08/2011 | Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Canada;Germany | |||
| 54 | EUCTR2011-002811-27-DK (EUCTR) | 07/11/2011 | 04/11/2011 | The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta | The 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, DMSc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Denmark | ||
| 55 | EUCTR2011-001465-41-BE (EUCTR) | 20/07/2011 | 23/05/2011 | Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 1;Phase 2 | Canada;Belgium;Germany | ||
| 56 | NCT01417091 (ClinicalTrials.gov) | June 2011 | 4/8/2011 | Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta | A 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 | Osteogenesis Imperfecta | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | United States;Belgium;Canada;Germany |
| 57 | NCT01061099 (ClinicalTrials.gov) | February 2010 | 1/2/2010 | Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta | A Pilot Study to Assess the Safety and Feasibility of Repeated Infusions of Mesenchymal Stromal Cells (MSC) in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta Type II;Osteogenesis Imperfecta Type III | Biological: Mesenchymal Stromal Cells | Nationwide Children's Hospital | NULL | Completed | N/A | 19 Years | Both | 5 | Phase 1 | United States |
| 58 | NCT00982124 (ClinicalTrials.gov) | October 2007 | 21/9/2009 | An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta | An International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Shriners Hospitals for Children | Novartis | Completed | N/A | 12 Months | Both | 14 | Phase 3 | Canada |
| 59 | NCT00655681 (ClinicalTrials.gov) | September 2007 | 4/4/2008 | Prevention of Post Operative Bone Loss in Children | Prevention of Post Operative Bone Loss in Children | Osteoporosis;Cerebral Palsy;Spina Bifida;Osteopenia;Osteogenesis Imperfecta | Drug: pamidronate;Other: saline | University of New Mexico | Thrasher Research Fund | Completed | 4 Years | 18 Years | Both | 24 | N/A | United States |
| 60 | NCT02303873 (ClinicalTrials.gov) | March 2007 | 19/11/2014 | Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta | Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective Study | Osteogenesis Imperfecta | Drug: Alendronate | Peking Union Medical College Hospital | National Natural Science Foundation of China | Completed | N/A | 18 Years | Both | 99 | Phase 4 | NULL |
| 61 | EUCTR2004-000485-13-DK (EUCTR) | 29/01/2007 | 29/11/2006 | A 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 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 62 | EUCTR2004-000485-13-CZ (EUCTR) | 04/10/2006 | 25/08/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 63 | EUCTR2004-000485-13-ES (EUCTR) | 27/08/2006 | 27/06/2006 | Estudio 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 | Estudio 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 Imperfecta | Product Name: risedronato sódico 2.5mg INN or Proposed INN: ácido risedrónico Product Name: Risedronato sódico 5mg INN or Proposed INN: ácido risedrónico | Procter & Gamble Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 64 | EUCTR2004-000485-13-HU (EUCTR) | 25/08/2006 | 14/07/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Finland;Hungary;Czech Republic;Denmark;Spain | |||
| 65 | EUCTR2004-000485-13-BE (EUCTR) | 22/08/2006 | 30/05/2006 | A 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 | A 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 | Product Name: risedronate sodium 2.5mg INN or Proposed INN: risedronic acid Product Name: Risedronate sodium 5mg INN or Proposed INN: risedronic acid | Procter & Gamble Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Czech Republic;Hungary;Finland;Spain;Belgium;Denmark | |||
| 66 | EUCTR2004-000485-13-FI (EUCTR) | 28/03/2006 | 10/02/2006 | A 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 | A 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 | Product 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | |||
| 67 | EUCTR2004-001666-40-GB (EUCTR) | 14/06/2005 | 13/05/2005 | An 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 | An 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 Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Hungary;United Kingdom | |||
| 68 | NCT00131469 (ClinicalTrials.gov) | June 2005 | 16/8/2005 | Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta | A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI) | Osteogenesis Imperfecta | Drug: Teriparatide (FORTEO);Drug: Placebos | Oregon Health and Science University | Eli Lilly and Company;Osteogenesis Imperfecta Foundation;National Institutes of Health (NIH);National Center for Research Resources (NCRR) | Completed | 18 Years | 85 Years | All | 79 | Phase 4 | United States |
| 69 | EUCTR2004-005275-42-IT (EUCTR) | 21/03/2005 | 23/01/2008 | Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis Imperfecta | Study 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 VERONA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 70 | EUCTR2004-001666-40-HU (EUCTR) | 01/02/2005 | 25/11/2004 | An 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 | An 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 Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Hungary;United Kingdom | |||
| 71 | NCT00106028 (ClinicalTrials.gov) | November 2004 | 18/3/2005 | Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children | Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children | Osteogenesis Imperfecta | Drug: risedronate sodium (Actonel);Drug: Placebo | Warner Chilcott | NULL | Completed | 4 Years | 15 Years | All | 143 | Phase 3 | United States;Australia;Belgium;Chile;Czech Republic;Finland;Germany;Hungary;Italy;Poland;South Africa;Spain;United Kingdom |
| 72 | NCT00131118 (ClinicalTrials.gov) | July 2004 | 15/8/2005 | Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta | Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Novartis Pharmaceuticals | NULL | Completed | 1 Year | 17 Years | All | 127 | Phase 2 | United States |
| 73 | NCT00187018 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study | Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study | Osteogenesis Imperfecta | Biological: Bone marrow transplant | St. Jude Children's Research Hospital | NULL | Completed | N/A | N/A | Both | 9 | N/A | United States |
| 74 | NCT00063479 (ClinicalTrials.gov) | June 2003 | 27/6/2003 | Bisphosphonate Treatment of Osteogenesis Imperfecta | Bisphosphonate Treatment of Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Novartis Pharmaceuticals | NULL | Completed | 3 Months | 17 Years | All | 158 | Phase 2 | United States;Germany |
| 75 | NCT00005901 (ClinicalTrials.gov) | June 2000 | 6/6/2000 | Pamidronate to Treat Osteogenesis Imperfecta in Children | A Trial of Pamidronate in Children With Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Pamidronate (Aredia) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | National Institutes of Health Clinical Center (CC) | Completed | N/A | 16 Years | All | 34 | Phase 3 | United States;Canada |
| 76 | NCT00159419 (ClinicalTrials.gov) | August 1999 | 7/9/2005 | Bisphosphonate Therapy for Osteogenesis Imperfecta | Bisphosphonate Therapy for Osteogenesis Imperfecta | Osteogenesis Imperfecta;Osteoporosis;Paget Disease of Bone | Drug: Alendronate;Drug: Pamidronate | Indiana University School of Medicine | NULL | Completed | 3 Years | 21 Years | All | 18 | Phase 4 | United States |
| 77 | NCT00705120 (ClinicalTrials.gov) | November 1995 | 23/6/2008 | Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation | Treatment of Severe (Types II and III) Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation | Osteogenesis Imperfecta | Other: Bone Marrow Cell Transplantation;Radiation: Irradiation, Total Body;Drug: Cyclophosphamide;Drug: Cyclosporin;Procedure: Mesenchymal Stem Cell Transplantation;Drug: Busulfan | St. Jude Children's Research Hospital | NULL | Completed | 3 Years | N/A | Both | 9 | Phase 1 | United States |
| 78 | NCT00001305 (ClinicalTrials.gov) | November 5, 1991 | 3/11/1999 | Growth Hormone Therapy in Osteogenesis Imperfecta | Studies of Growth Deficiency and Growth Hormone Treatment in Children With Osteogenesis Imperfecta Types III and IV | Osteogenesis Imperfecta | Drug: Humatrope | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 3 Years | 16 Years | All | 42 | Phase 3 | United States |
| 79 | EUCTR2014-000184-40-IT (EUCTR) | 15/06/2021 | Study 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 - 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 80 | EUCTR2014-000184-40-FR (EUCTR) | 18/06/2015 | Study 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. | NULL | NA | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 81 | EUCTR2018-000550-21-FR (EUCTR) | 27/07/2020 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 82 | EUCTR2018-000550-21-PL (EUCTR) | 16/10/2018 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 83 | EUCTR2015-003539-37-Outside-EU/EEA (EUCTR) | 07/03/2016 | Bisphosphonate Treatment of Osteogenesis Imperfecta | An 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: Zometa | Novartis | NULL | NA | Female: yes Male: yes | 158 | United States | ||||
| 84 | EUCTR2014-000184-40-BG (EUCTR) | 05/12/2014 | Study 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany | |||
| 85 | EUCTR2014-000184-40-Outside-EU/EEA (EUCTR) | 26/11/2014 | Study 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: 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. | NULL | NA | Female: yes Male: yes | 150 | United States;Australia;Canada | ||||
| 86 | EUCTR2018-000550-21-BE (EUCTR) | 14/01/2019 | Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta | Multicenter, 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 Inc | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 87 | EUCTR2004-001666-40-BE (EUCTR) | 05/09/2005 | An 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 | An 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 Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | Hungary;Belgium;United Kingdom |