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Recruiting Phase 3 NCT05972551

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

Phase 3 – large-scale trial before approval
Conditions: Osteogenesis Imperfecta

Sponsor: Amgen

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 17
Australia (1)
Monash Childrens Hospital
Clayton , Victoria
Belgium (1)
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Canada (1)
Childrens Hospital of Eastern Ontario
Ottawa , Ontario
China (1)
Peking Union Medical College Hospital
Beijing , Beijing Municipality
France (1)
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux
Germany (1)
Universitaetsklinikum Koeln
Cologne
Hungary (1)
Semmelweis Egyetem
Budapest
Italy (1)
IRCCS Istituto Giannina Gaslini
Genova
Japan (1)
Okayama Saiseikai Outpatient Center Hospital
Okayama , Okayama-ken
Poland (1)
Centermed Krakow Sp zoo
Krakow
Saudi Arabia (1)
King Faisal Specialist Hospital and Research Centre
Riyadh
Slovakia (1)
Narodny ustav detskych chorob
Bratislava
Spain (1)
Hospital de Cruces
Barakaldo , Basque Country
Switzerland (1)
Universitaets-Kinderspital beider Basel
Basel
Turkey (1)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara
United Kingdom (1)
Queen Elizabeth University Hospital
Glasgow
United States (1)
Childrens Hospital of Alabama
Birmingham , Alabama
TERMINATED
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
5 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
22.04.2024
Completion date
25.08.2027
Registry ID
NCT05972551
Source
anzctr
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