RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-22
Study Completion:2027-05-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05972551

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.

Ages Eligible for Study:5 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  2. * 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.
  3. * 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.
  4. * 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).
  5. * Meets at least one of the following:
  6. * 3 or more fractures within the previous 2 years, or
  7. * 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or
  8. * 2 or more prevalent vertebral fractures.
  1. * History of an electrophoresis pattern inconsistent with type I, III or IV OI.
  2. * 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.
  3. * History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21287
United States
Boston Childrens Hospital
Boston, Massachusetts, 02115
United States
Mayo Clinic Childrens Center
Rochester, Minnesota, 55905
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-3157
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22
Study Completion Date2027-05-27

Study Record Updates

Study Start Date2024-04-22
Study Completion Date2027-05-27

Terms related to this study

Keywords Provided by Researchers

  • Osteogenesis Imperfecta
  • Romosozumab
  • EVENITY®
  • Bisphosphonates

Additional Relevant MeSH Terms

  • Osteogenesis Imperfecta