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

Description

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.

Conditions

Osteogenesis Imperfecta

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Study Overview

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Study Details

Study 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.

A Phase 3, Open-Label, Multicenter, Randomized Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

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

Condition
Osteogenesis Imperfecta
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Baltimore

Kennedy Krieger Institute, Baltimore, Maryland, United States, 21287

Boston

Boston Childrens Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic Childrens Center, Rochester, Minnesota, United States, 55905

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212-3157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • * 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).
  • * 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.
  • * 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.

Ages Eligible for Study

5 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-05-27