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Набира участници Фаза 3 NCT05972551

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Фаза 3 – широко изпитване преди одобрение
Заболявания: Osteogenesis Imperfecta

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
Кой може да участва
Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. OR * Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * Ambulatory male and female children and adolescents, age 5 to \<18 years, including ambulatory 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: facial shape, 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 1 prevalent vertebral fracture, or * 2 or more prevalent vertebral fractures. 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 type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease. * History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
Места на провеждане 17
Австралия (1)
Monash Childrens Hospital
Clayton , Victoria
Белгия (1)
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Канада (1)
Childrens Hospital of Eastern Ontario
Ottawa , Ontario
Китай (1)
Peking Union Medical College Hospital
Beijing , Beijing Municipality
Франция (1)
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux
Германия (1)
Universitaetsklinikum Koeln
Cologne
Унгария (1)
Semmelweis Egyetem
Budapest
Италия (1)
IRCCS Istituto Giannina Gaslini
Genova
Япония (1)
Okayama Saiseikai Outpatient Center Hospital
Okayama , Okayama-ken
Полша (1)
Centermed Krakow Sp zoo
Krakow
Saudi Arabia (1)
King Faisal Specialist Hospital and Research Centre
Riyadh
Словакия (1)
Narodny ustav detskych chorob
Bratislava
Испания (1)
Hospital de Cruces
Barakaldo , Basque Country
Швейцария (1)
Universitaets-Kinderspital beider Basel
Basel
Турция (1)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara
Великобритания (1)
Queen Elizabeth University Hospital
Glasgow
САЩ (1)
Childrens Hospital of Alabama
Birmingham , Alabama
TERMINATED
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
5 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
22.04.2024
Крайна дата
25.08.2027
Регистрационен номер
NCT05972551
Източник
anzctr
Запитване за медицински туризъм

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