DDrare: Database of Drug Development for Rare Diseases

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

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

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	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
2	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
3	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

No.

TrialID

Date_
enrollment

Date_
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Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

Canada;Germany

EUCTR2011-001465-41-BE
(EUCTR)

20/07/2011

23/05/2011

Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta

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

Phase 1;Phase 2

Canada;Belgium;Germany