An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

  • End date
    Feb 19, 2023
  • participants needed
  • sponsor
Updated on 18 September 2022


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).

Condition Osteogenesis Imperfecta
Treatment Vitamin D, calcium, Romosozumab
Clinical Study IdentifierNCT04545554
Last Modified on18 September 2022


Yes No Not Sure

Inclusion Criteria

Ambulatory male or female children 5 to 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

Exclusion Criteria

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/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 acide with in 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
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