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 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:14] 

Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT04152551November 201911 November 2019Effects of Bisphosphonates on OI-Related Hearing LossEffects of Bisphosphonates on OI-Related Hearing Loss: A Pilot StudyOsteogenesis ImperfectaDrug: Risedronate Oral TabletHospital for Special Surgery, New YorkThe New York Community Trust;Weill Cornell Medicine;Northwell HealthNot recruiting6 Years100 YearsAll100Phase 4
2NCT04009733October 3, 20194 November 2019Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI StudyEpigenetic Regulation of Osteogenesis Imperfecta Severity : miROI StudyOsteogenesis ImperfectaBiological: Blood sampleHospices Civils de LyonRecruiting18 YearsN/AAll100N/AFrance
3NCT03706482August 12, 201926 August 2019Boost Brittle Bones Before BirthAn Exploratory, Open Label, Multiple Dose, Multicentre Phase I/II Trial Evaluating Safety and Efficacy of Postnatal or Prenatal and Postnatal Intravenous Administration of Allogeneic Expanded Fetal Mesenchymal Stem Cells for the Treatment of Severe Osteogenesis Imperfecta Compared With a Combination of Historical and Untreated Prospective ControlsOsteogenesis ImperfectaBiological: BOOST cellsCecilia GötherströmKarolinska University Hospital;Great Ormond Street Hospital for Children NHS Foundation Trust;University College, London;Universitätsklinikum Köln;UMC Utrecht;Leiden University Medical Center;Lund UniversityRecruitingN/A12 MonthsAll210Phase 1/Phase 2Sweden
4EUCTR2015-003699-60-SE28/09/201815 October 2018Treatment of severe congenital Brittle bone disease after or before and after birth.An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with a combination of historical and untreated prospective controls.Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Product Name: Expanded human first trimester fetal liver-derived mesenchymal stem cells
Product Code: BOOST cells
Pharmaceutical Form: Infusion
Karolinska InstitutetAuthorisedFemale: yes
Male: yes
210Phase 1;Phase 2Sweden
5NCT03638128July 26, 201828 October 2019Open-label Extension Denosumab Study in Children and Young Adults With Osteogenesis ImperfectaMulticenter, 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 ImperfectaOsteogenesis Imperfecta (OI)Drug: DenosumabAmgenRecruiting5 Years20 YearsAll150Phase 3United States;Belgium;Canada;Germany;Hungary;Italy;Poland;United Kingdom
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6EUCTR2018-000550-21-HU06/07/201823 July 2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaOsteogenesis 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 IncAuthorisedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
7JPRN-UMIN0000312902018/04/012 April 2019Efficacy of pamidronate for adult osteogenesis imperfecta: uncontrolled study.Osteogenesis imperfectaPamidronate disodium intervenous for drip use; 15mg/day (available up to 30mg/day), 1 infection/day x 3 dats, every 4 months, total 16 months.Kobe University HospitalNot Recruiting20years-oldNot applicableMale and Female10Not applicableJapan
8NCT03064074November 15, 201728 January 2019Safety of Fresolimumab in the Treatment of Osteogenesis ImperfectaMulticenter Study to Evaluate Safety of Fresolimumab in Adults With Moderate-to-severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: FresolimumabBaylor College of MedicineGenzyme, a Sanofi Company;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 FloridaRecruiting18 YearsN/AAll16Phase 1United States
9NCT03216486October 31, 20178 January 2018An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaA Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: BPS804Mereo BioPharmaICON Clinical ResearchNot recruiting18 YearsN/AAll0Phase 2United States
10NCT03118570September 11, 201725 March 2019A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804).Osteogenesis Imperfecta, Type I;Osteogenesis Imperfecta Type III;Osteogenesis Imperfecta Type IVDrug: BPS804Mereo BioPharmaICON Clinical ResearchNot recruiting18 Years75 YearsAll100Phase 2United States;Canada;Denmark;France;United Kingdom
No.TrialIDDate_
enrollement
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11EUCTR2016-005096-27-DK23/06/201723 July 2018A study of test product setrusumab in adults with brittle bone syndrome.A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804).Osteogenesis imperfecta
MedDRA version: 20.0 Level: PT Classification code 10031243 Term: Osteogenesis imperfecta System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: setrusumab
Product Code: BPS804
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.AuthorisedFemale: yes
Male: yes
100Phase 2France;United States;Canada;Denmark;United Kingdom
12NCT03169192June 1, 201716 December 2017Diagnosis of Osteogenesis Imperfecta in ChildrenMolecular Genetic Study of Suspected Cases of Osteogenesis Imperfecta Attending Assiut University Children HospitalBone Disease, MetabolicDrug: Zoledronic AcidAssiut UniversityNot recruiting1 Month18 YearsAll40N/AEgypt
13NCT03208582April 1, 201717 September 2018Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?Osteogenesis ImperfectaDrug: Risedronate Sodium;Dietary Supplement: Calcichew tabletsSheffield Children's NHS Foundation TrustNot recruiting4 Years16 YearsAll13Phase 2United Kingdom
14EUCTR2016-003606-14-GB31/01/20173 April 2017Brittle bones - do they react normally after treatment with bisphosphonates?Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta? - BAMES studyOsteogenesis 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 TrustAuthorisedFemale: yes
Male: yes
Phase 2United Kingdom
15NCT03735537November 1, 201619 November 2018Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidTreatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic AcidOsteogenesis ImperfectaDrug: Teriparatide Pen Injector;Drug: Zoledronic AcidUniversity of EdinburghNHS LothianRecruiting18 YearsN/AAll380Phase 4Ireland;United Kingdom
No.TrialIDDate_
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PhaseCountries
16EUCTR2014-000184-40-CZ11/09/201423 October 2017Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaOsteogenesis 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 RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
17NCT02172885April 20148 April 2019Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis ImperfectaMesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis ImperfectaOsteogenesis ImperfectaBiological: Mesenchymal Stem CellsHospital de CrucesHospital Universitario Getafe;Hospital Infantil Universitario Niño Jesús, Madrid, SpainNot recruiting6 Months12 YearsAll2Phase 1Spain
18EUCTR2012-002553-38-ES09/08/20139 September 2013Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfectaMesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta - TERCELOIOsteogenesis 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 AguirreAuthorisedFemale: yes
Male: yes
Spain
19NCT04115774June 28, 201322 October 2019Registry of Osteogenesis ImperfectaRegistry of Osteogenesis Imperfecta That Collects Clinical, Functional, Genetic, Genealogical, Imaging, Surgical, Quality of Life Data. Data Are Linked to Patients Biological SampleOsteogenesis ImperfectaDrug: bisphosphonatesLuca SangiorgiRecruitingN/AN/AAll5000N/AItaly
20JPRN-UMIN0000106152013/04/302 April 2019Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)osteogenesis imperfectaEighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient's BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient's BMD does not reach to the normal range for age, alendronate will be continued for another 6 months.Tohoku University School of Medicine, Department of PediatricsRecruitingNot applicable15years-oldMale and Female10Not applicableJapan
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21EUCTR2012-002887-29-DE13/02/201316 November 2015New therapeutic approach in OI with the antibody DenosumabTranslational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AKIn 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 CologneNot RecruitingFemale: yes
Male: yes
Germany
22NCT01799798February 201319 February 2015Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody DenosumabTRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMABOsteogenesis ImperfectaDrug: DenosumabUniversity of CologneNot recruiting5 Years11 YearsBoth10Phase 2Germany
23NCT01679080November 20127 October 2019The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaThe Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic acid;Drug: Teriparatide;Other: No active treatmentUniversity of AarhusNot recruiting22 Years70 YearsAll80Phase 2Denmark
24NCT01713231September 201219 February 2015Effect of High-Dose Vitamin D on Bone Density in Osteogenesis ImperfectaEffect of High-Dose Vitamin D on Bone Density in Osteogenesis ImperfectaOsteogenesis ImperfectaDietary Supplement: standard-dose vitamin D (400IU per day);Dietary Supplement: high-dose vitamin D (2000 IU per day)Louis-Nicolas Veilleux Ph.D.Not recruiting6 Years19 YearsBoth60Phase 4Canada
25EUCTR2011-002811-27-DK07/11/20111 February 2016The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis ImperfectaThe Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta - OI-treatmentOsteogenesis 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, DMScAuthorisedFemale: yes
Male: yes
Denmark
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26EUCTR2011-001465-41-BE20/07/201121 August 2017Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfectaA randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NAPatients 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 AGNot RecruitingFemale: yes
Male: yes
15Phase 1;Phase 2Canada;Belgium;Germany
27NCT01061099February 20104 May 2015Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis ImperfectaA Pilot Study to Assess the Safety and Feasibility of Repeated Infusions of Mesenchymal Stromal Cells (MSC) in Children With Osteogenesis ImperfectaOsteogenesis Imperfecta Type II;Osteogenesis Imperfecta Type IIIBiological: Mesenchymal Stromal CellsNationwide Children's HospitalNot recruitingN/A19 YearsBoth5Phase 1United States
28NCT00982124October 20072 May 2016An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaAn International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidShriners Hospitals for ChildrenNovartisNot recruitingN/A12 MonthsBoth14Phase 3Canada
29NCT00655681September 200719 February 2015Prevention of Post Operative Bone Loss in ChildrenPrevention of Post Operative Bone Loss in ChildrenOsteoporosis;Cerebral Palsy;Spina Bifida;Osteopenia;Osteogenesis ImperfectaDrug: pamidronate;Other: salineUniversity of New MexicoThrasher Research FundNot recruiting4 Years18 YearsBoth24N/AUnited States
30NCT02303873March 200719 February 2015Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis ImperfectaEfficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective StudyOsteogenesis ImperfectaDrug: AlendronatePeking Union Medical College HospitalNational Natural Science Foundation of ChinaNot recruitingN/A18 YearsBoth99Phase 4
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31EUCTR2004-000485-13-FI28/03/200619 March 2012A 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. - POISEA 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. - POISEOsteogenesis ImperfectaProduct 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 LtdNot RecruitingFemale: yes
Male: yes
124Hungary;Finland;Czech Republic;Denmark;Spain
32NCT00131469June 200525 March 2019Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis ImperfectaA Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI)Osteogenesis ImperfectaDrug: Teriparatide (FORTEO)Oregon Health and Science UniversityEli Lilly and Company;Osteogenesis Imperfecta Foundation;National Institutes of Health (NIH);National Center for Research Resources (NCRR)Not recruiting18 Years85 YearsAll79Phase 4United States
33EUCTR2004-005275-42-IT21/03/200519 March 2012Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis ImperfectaStudy on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis ImperfectaOsteogenesis 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 VERONANot RecruitingFemale: yes
Male: yes
Italy
34EUCTR2004-001666-40-HU01/02/20051 May 2012An 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 - 2202EAn 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 - 2202EOsteogenesis ImperfectaProduct Name: zoledronic acid
Product Code: ZOL446
Pharmaceutical Form: Solution for infusion
Novartis Pharma AGNot RecruitingFemale: yes
Male: yes
130Hungary;United Kingdom
35NCT00106028November 200419 October 2017Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenSafety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in ChildrenOsteogenesis ImperfectaDrug: risedronate sodium (Actonel);Drug: PlaceboWarner ChilcottNot recruiting4 Years15 YearsAll143Phase 3United States;Australia;Belgium;Chile;Czech Republic;Finland;Germany;Hungary;Italy;Poland;South Africa;Spain;United Kingdom
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36NCT00131118July 200416 December 2017Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaEfficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNot recruiting1 Year17 YearsAll127Phase 2United States
37NCT00187018March 200416 March 2015Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot StudyMarrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot StudyOsteogenesis ImperfectaBiological: Bone marrow transplantSt. Jude Children's Research HospitalNot recruitingN/AN/ABoth9N/AUnited States
38NCT00063479June 200316 December 2017Bisphosphonate Treatment of Osteogenesis ImperfectaBisphosphonate Treatment of Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Zoledronic AcidNovartis PharmaceuticalsNot recruiting3 Months17 YearsAll158Phase 2United States;Germany
39NCT00005901June 200019 October 2017Pamidronate to Treat Osteogenesis Imperfecta in ChildrenA Trial of Pamidronate in Children With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Pamidronate (Aredia)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institutes of Health Clinical Center (CC)Not recruitingN/A16 YearsAll34Phase 3United States;Canada
40NCT00159419August 199916 December 2017Bisphosphonate Therapy for Osteogenesis ImperfectaBisphosphonate Therapy for Osteogenesis ImperfectaOsteogenesis Imperfecta;Osteoporosis;Paget Disease of BoneDrug: Alendronate;Drug: PamidronateIndiana University School of MedicineNot recruiting3 Years21 YearsAll18Phase 4United States
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41NCT00705120November 199519 February 2015Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationTreatment of Severe (Types II and III) Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationOsteogenesis ImperfectaOther: Bone Marrow Cell Transplantation;Radiation: Irradiation, Total Body;Drug: Cyclophosphamide;Drug: Cyclosporin;Procedure: Mesenchymal Stem Cell Transplantation;Drug: BusulfanSt. Jude Children's Research HospitalNot recruiting3 YearsN/ABoth9Phase 1United States
42NCT00001305November 5, 199116 December 2017Growth Hormone Therapy in Osteogenesis ImperfectaStudies of Growth Deficiency and Growth Hormone Treatment in Children With Osteogenesis Imperfecta Types III and IVOsteogenesis ImperfectaDrug: Humatrope;Other: Growth hormone;Drug: Nutropin;Drug: GRHEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting3 Years16 YearsAll52Phase 3United States

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