274. 骨形成不全症 ［臨床試験数：42，薬物数：55（DrugBank：13），標的遺伝子数：12，標的パスウェイ数：70］
Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04152551 | November 2019 | 11 November 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 Cornell Medicine;Northwell Health | Not recruiting | 6 Years | 100 Years | All | 100 | Phase 4 | |
| 2 | NCT04009733 | October 3, 2019 | 4 November 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 | Recruiting | 18 Years | N/A | All | 100 | N/A | France | |
| 3 | NCT03706482 | August 12, 2019 | 26 August 2019 | 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 | Cecilia Götherström | 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 | 12 Months | All | 210 | Phase 1/Phase 2 | Sweden |
| 4 | EUCTR2015-003699-60-SE | 28/09/2018 | 15 October 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 Pharmaceutical Form: Infusion | Karolinska Institutet | Authorised | Female: yes Male: yes | 210 | Phase 1;Phase 2 | Sweden | |||
| 5 | NCT03638128 | July 26, 2018 | 28 October 2019 | Open-label Extension Denosumab Study in Children and Young Adults With Osteogenesis Imperfecta | Multicenter, Single-arm Open-label Extensión 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 | Amgen | Recruiting | 5 Years | 20 Years | All | 150 | Phase 3 | United States;Belgium;Canada;Germany;Hungary;Italy;Poland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2018-000550-21-HU | 06/07/2018 | 23 July 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: AMG 162 Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- | Amgen Inc | Authorised | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany | |||
| 7 | JPRN-UMIN000031290 | 2018/04/01 | 2 April 2019 | Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study. | 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 | Not Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan | ||
| 8 | NCT03064074 | November 15, 2017 | 28 January 2019 | 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;Shriners Hospitals for Children;Hugo W. Moser Research Institute at Kennedy Krieger, Inc.;Hospital for Special Surgery, New York;University of California, Los Angeles;University of Nebraska;Oregon Health and Science University;University of South Florida | Recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 9 | NCT03216486 | October 31, 2017 | 8 January 2018 | 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 | Not recruiting | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 10 | NCT03118570 | September 11, 2017 | 25 March 2019 | 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 | Mereo BioPharma | ICON Clinical Research | Not recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | United States;Canada;Denmark;France;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2016-005096-27-DK | 23/06/2017 | 23 July 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 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Mereo Biopharma 3 Ltd. | Authorised | Female: yes Male: yes | 100 | Phase 2 | France;United States;Canada;Denmark;United Kingdom | |||
| 12 | NCT03169192 | June 1, 2017 | 16 December 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 | Not recruiting | 1 Month | 18 Years | All | 40 | N/A | Egypt | |
| 13 | NCT03208582 | April 1, 2017 | 17 September 2018 | 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 | Not recruiting | 4 Years | 16 Years | All | 13 | Phase 2 | United Kingdom | |
| 14 | EUCTR2016-003606-14-GB | 31/01/2017 | 3 April 2017 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Risedronate Sodium CAS Number: 115436-72-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Actonel Once a Week 35 mg film-coated tablets Product Name: Actonel Once a Week 35 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Risedronate Sodium CAS Number: 115436-72-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- | Sheffield Children's NHS Foundation Trust | Authorised | Female: yes Male: yes | Phase 2 | United Kingdom | ||||
| 15 | NCT03735537 | November 1, 2016 | 19 November 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 |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2014-000184-40-CZ | 11/09/2014 | 23 October 2017 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: AMG 162 Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- | Amgen, Inc. | 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 | |||
| 17 | NCT02172885 | April 2014 | 8 April 2019 | 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 | Not recruiting | 6 Months | 12 Years | All | 2 | Phase 1 | Spain |
| 18 | EUCTR2012-002553-38-ES | 09/08/2013 | 9 September 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 Pharmaceutical Form: Living tissue equivalent INN or Proposed INN: células mesenquimales troncales adultas alogénicas de médula ósea no expandidas Current Sponsor code: células mesenquimales troncales adultas alogénicas de médula ósea no expa (ref cruzada PEI Nº 12-088 Other descriptive name: células mesenquimales troncales adultas alogénicas de médula ósea no expandidas(ref cruzada PEI nº 12-088) Concentration unit: Other Concentration type: equal Concentration number: 1- | Itziar Astigarraga Aguirre | Authorised | Female: yes Male: yes | Spain | |||||
| 19 | NCT04115774 | June 28, 2013 | 22 October 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 | Recruiting | N/A | N/A | All | 5000 | N/A | Italy | |
| 20 | JPRN-UMIN000010615 | 2013/04/30 | 2 April 2019 | Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) | 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 | Recruiting | Not applicable | 15years-old | Male and Female | 10 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2012-002887-29-DE | 13/02/2013 | 16 November 2015 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: DENOSUMAB CAS Number: 615258-40-7 Other descriptive name: DENOSUMAB Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 60- | University of Cologne | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 22 | NCT01799798 | February 2013 | 19 February 2015 | 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 | Not recruiting | 5 Years | 11 Years | Both | 10 | Phase 2 | Germany | |
| 23 | NCT01679080 | November 2012 | 7 October 2019 | 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 | Not recruiting | 22 Years | 70 Years | All | 80 | Phase 2 | Denmark | |
| 24 | NCT01713231 | September 2012 | 19 February 2015 | 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. | Not recruiting | 6 Years | 19 Years | Both | 60 | Phase 4 | Canada | |
| 25 | EUCTR2011-002811-27-DK | 07/11/2011 | 1 February 2016 | 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 Pharmaceutical Form: Solution for injection in pre-filled pen Pharmaceutical form of the placebo: Solution for injection in pre-filled pen Route of administration of the placebo: Subcutaneous use Trade Name: Aclasta Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use | Bente Langdahl, consultant, ass. professor, PhD, DMSc | Authorised | Female: yes Male: yes | Denmark | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2011-001465-41-BE | 20/07/2011 | 21 August 2017 | 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 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: NA CAS Number: NA Current Sponsor code: BPS804 Other descriptive name: Anti-sclerostin monoclonal antibody Concentration unit: mg milligram(s) Concentration type: equal | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 15 | Phase 1;Phase 2 | Canada;Belgium;Germany | |||
| 27 | NCT01061099 | February 2010 | 4 May 2015 | 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 | Not recruiting | N/A | 19 Years | Both | 5 | Phase 1 | United States | |
| 28 | NCT00982124 | October 2007 | 2 May 2016 | 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 | Not recruiting | N/A | 12 Months | Both | 14 | Phase 3 | Canada |
| 29 | NCT00655681 | September 2007 | 19 February 2015 | 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 | Not recruiting | 4 Years | 18 Years | Both | 24 | N/A | United States |
| 30 | NCT02303873 | March 2007 | 19 February 2015 | 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 | Not recruiting | N/A | 18 Years | Both | 99 | Phase 4 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2004-000485-13-FI | 28/03/2006 | 19 March 2012 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One-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 of One-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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: risedronic acid CAS Number: 115436-72-1 Current Sponsor code: NE-58095 Concentration unit: mg milligram(s) Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Actonel/Optinate 5mg film-coated tablets Product Name: Risedronate sodium 5mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: risedronic acid CAS Number: 115436-72-1 Current Sponsor code: NE-58095 Concentration unit: mg milligram(s) Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Procter & Gamble Ltd | Not Recruiting | Female: yes Male: yes | 124 | Hungary;Finland;Czech Republic;Denmark;Spain | ||||
| 32 | NCT00131469 | June 2005 | 25 March 2019 | 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) | Oregon Health and Science University | Eli Lilly and Company;Osteogenesis Imperfecta Foundation;National Institutes of Health (NIH);National Center for Research Resources (NCRR) | Not recruiting | 18 Years | 85 Years | All | 79 | Phase 4 | United States |
| 33 | EUCTR2004-005275-42-IT | 21/03/2005 | 19 March 2012 | 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) Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Somatropin CAS Number: 12629-01-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.3- Trade Name: NERIXIA*INFUS IV CONC 2F 100MG Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: VARI Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 34 | EUCTR2004-001666-40-HU | 01/02/2005 | 1 May 2012 | An international, multicenter, randomized, open-label, safety and efficacy trial of intravenous zoledronic acid administered either once or twice yearly in children with severe osteogenesis imperfecta, a 1-year extension to CZOL446H2202 - 2202E | An international, multicenter, randomized, open-label, safety and efficacy trial of intravenous zoledronic acid administered either once or twice yearly in children with severe osteogenesis imperfecta, a 1-year extension to CZOL446H2202 - 2202E | Osteogenesis Imperfecta | Product Name: zoledronic acid Product Code: ZOL446 Pharmaceutical Form: Solution for infusion | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 130 | Hungary;United Kingdom | ||||
| 35 | NCT00106028 | November 2004 | 19 October 2017 | 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 | Not recruiting | 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 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT00131118 | July 2004 | 16 December 2017 | 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 | Not recruiting | 1 Year | 17 Years | All | 127 | Phase 2 | United States | |
| 37 | NCT00187018 | March 2004 | 16 March 2015 | 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 | Not recruiting | N/A | N/A | Both | 9 | N/A | United States | |
| 38 | NCT00063479 | June 2003 | 16 December 2017 | Bisphosphonate Treatment of Osteogenesis Imperfecta | Bisphosphonate Treatment of Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: Zoledronic Acid | Novartis Pharmaceuticals | Not recruiting | 3 Months | 17 Years | All | 158 | Phase 2 | United States;Germany | |
| 39 | NCT00005901 | June 2000 | 19 October 2017 | 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) | Not recruiting | N/A | 16 Years | All | 34 | Phase 3 | United States;Canada |
| 40 | NCT00159419 | August 1999 | 16 December 2017 | 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 | Not recruiting | 3 Years | 21 Years | All | 18 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT00705120 | November 1995 | 19 February 2015 | 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 | Not recruiting | 3 Years | N/A | Both | 9 | Phase 1 | United States | |
| 42 | NCT00001305 | November 5, 1991 | 16 December 2017 | 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;Other: Growth hormone;Drug: Nutropin;Drug: GRH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 3 Years | 16 Years | All | 52 | Phase 3 | United States |