Phase
Condition
Connective Tissue Diseases
Musculoskeletal Diseases
Bone Neoplasm
Treatment
Bisphosphonate
Romosozumab
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participant has provided informed consent/assent prior to initiation of any studyspecific activities/procedures.
OR
Participant's legally authorized representative has provided informed consent whenthe participant is legally too young to provide informed consent and the participanthas provided written assent based on local regulations and/or guidelines prior toany study-specific activities/procedures being initiated.
Ambulatory male and female children and adolescents, age 5 to <18 years, includingambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI)population.
Clinical diagnosis of OI, defined as clinical history consistent with type I, III,or IV OI as determined by presence of expected phenotype (examples include: facialshape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features,fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis). o If familial, also must be autosomal dominant.
Meets at least one of the following:
3 or more fractures within the previous 2 years, or
1 or more nonvertebral fracture(s) within the previous 2 years and at least 1prevalent vertebral fracture, or
2 or more prevalent vertebral fractures.
Exclusion
Exclusion Criteria:
Disease Related
History of an electrophoresis pattern inconsistent with type I, III or IV OI.
History of known mutation in a gene other than collagen type I alpha 1/collagen typeI alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
History of congenital dislocation of the radial head, interosseous membranecalcification, or exuberant callus formation.
Study Design
Connect with a study center
Monash Childrens Hospital
Clayton, Victoria 3168
AustraliaActive - Recruiting
Perth Childrens Hospital
Nedlands, Western Australia 6909
AustraliaActive - Recruiting
Kepler Universitaetsklinikum GmbH
Linz, 4020
AustriaActive - Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
BelgiumActive - Recruiting
Childrens Hospital of Eastern Ontario
Ottawa, Ontario K1H 8L1
CanadaActive - Recruiting
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec H3T 1C5
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux Cedex, 33076
FranceActive - Recruiting
Hopital Necker Enfants Malades
Paris Cedex 15, 75743
FranceActive - Recruiting
Universitaetsklinikum Koeln
Koeln, 50937
GermanyActive - Recruiting
Universitaetsklinikum Wuerzburg
Wuerzburg, 97074
GermanyActive - Recruiting
Semmelweis Egyetem
Budapest, 1094
HungaryActive - Recruiting
Okayama Saiseikai Outpatient Center Hospital
Okayama-shi, Okayama 700-0013
JapanActive - Recruiting
Okayama University Hospital
Okayama-shi, Okayama 700-8558
JapanActive - Recruiting
Osaka Womens and Childrens Hospital
Izumi-shi, Osaka 594-1101
JapanActive - Recruiting
National Center for Child Health and Development
Setagaya-ku, Tokyo 157-8535
JapanActive - Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
PolandActive - Recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds
Lodz, 91-738
PolandActive - Recruiting
Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia
Tychy, 43-100
PolandActive - Recruiting
Narodny ustav detskych chorob
Bratislava, 833 40
SlovakiaActive - Recruiting
Hospital Sant Joan de Deu
Esplugues De Llorbregat, Cataluña 08950
SpainActive - Recruiting
Hospital Universitario de Getafe
Getafe, Madrid 28905
SpainActive - Recruiting
Hospital de Cruces
Baracaldo, País Vasco 48903
SpainActive - Recruiting
Hospital Universitario Infantil Niño Jesus
Madrid, 28009
SpainActive - Recruiting
Universitaets-Kinderspital beider Basel
Basel, 4031
SwitzerlandActive - Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
SwitzerlandActive - Recruiting
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06500
TurkeyActive - Recruiting
Gazi Universitesi Tip Fakultesi
Ankara, 06500
TurkeyActive - Recruiting
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890
TurkeyActive - Recruiting
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100
TurkeyActive - Recruiting
Karadeniz Teknik Universitesi Hastanesi
Trabzon, 61080
TurkeyActive - Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
United KingdomActive - Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Indiana University
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Kennedy Krieger Institute
Baltimore, Maryland 21287
United StatesActive - Recruiting
Boston Childrens Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Mayo Clinic Childrens Center
Rochester, Minnesota 55905
United StatesTerminated
Gillette Childrens Hospital and Clinic Saint Paul
Saint Paul, Minnesota 55101
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37212-3157
United StatesActive - Recruiting
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