Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Completed · Phase 1

Conditions studied: Osteogenesis Imperfecta

In brief

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).

Key facts

Study ID

NCT04545554

Run by

Amgen

People needed

25

Starts

2021-01-21

Expected to finish

2023-03-30

Last updated by the study team

2024-04-15

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ambulatory male or female children 5 to less than 18 years of age upon entry into screening
• Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI as determined by presence of expected phenotype and lack of additional features unrelated to type I-IV OI

You may not qualify if…

• History of an electrophoresis pattern inconsistent with type I to type IV OI
• History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1AI/COL1A2) causing OI or other metabolic bone disease
• History of other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
• History of Kawasaki disease, rheumatic myocarditis, ischemic cardiomyopathy, inherited cardiomyopathies, nephrotic syndrome, familial hypercholesterolemia, stroke, or any thromboembolic disorder
• Unhealed fracture as defined by orthopedic opinion
• Symptoms associated with skull abnormalities such as basilar invagination, basilar impression or Chiari malformation
• Prior treatment with anti-sclerostin antibody, fluoride or strontium, parathyroid hormone (PTH) within 12 months prior to screening, denosumab within 12 months or zoledronic acid within 6 months prior to first dose
• Less than 2 evaluable vertebrae by DXA evaluation in the region of interest, L1 - L4, as confirmed by the central imaging laboratory.
• Clinically significant valvular heart disease based on local echocardiogram (ECHO) results.

Where it is running

• Riley Hospital for Children — Indianapolis, Indiana, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Kepler Universitaetsklinikum GmbH — Linz, Austria
• Uniklinik Köln — Cologne, Germany
• General Children Hospital Panagioti and Aglaias Kyriakou — Athens, Greece
• Semmelweis Egyetem — Budapest, Hungary
• IRCCS Ospedale Pediatrico Bambino Gesu — Roma, Italy
• Hospital de Cruces — Barakaldo, Basque Country, Spain
• Hospital Sant Joan de Deu — Esplugues de Llobregat, Catalonia, Spain
• Hospital Universitario de Getafe — Getafe, Madrid, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain
• Gazi Universitesi Tip Fakultesi — Ankara, Turkey (Türkiye)
• Koc Universitesi Hastanesi — Istanbul, Turkey (Türkiye)
• Ege Universitesi Ilac Gelistirme ve Farmakokinetik Arastirma Uygulama Merkezi (ARGEFAR) — Izmir, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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