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Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

NCT02352753•Amgen

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

Detailed Description

To evaluate the effect of denosumab in lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age (at the time of screening) on a 3-Month Dosing Regimen with osteogenesis imperfecta (OI)

Eligibility

Age

2 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility criteria relates to initial enrollment into this study (6-Month Dosing Regimen). Subjects reconsenting to a 3-Month Dosing Regimen will not repeat eligibility assessments
•Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI Clinical severity of OI as defined by 2 or more prevalent vertebral compression fractures; OR1 prevalent vertebral compression fracture and 1 or more nonvertebral fractures within the previous 2 years; OR 3 or more fractures within the previous 2 years.

Exclusion Criteria

•Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover
•Currently unhealed fracture or osteotomy as defined by orthopedic opinion
•Osteotomy within 5 months of screening
•Evidence of untreated oral cavities or oral infections
•Recent or planned invasive dental procedure
•Surgical tooth extraction which has not healed by screening
•History of an electrophoresis pattern inconsistent with type I to IV OI
•History of genetic testing results inconsistent with type I to IV OI
•Abnormalities of the following per central laboratory reference ranges at screening: Serum albumin corrected calcium \< lower limit of normal (LLN) Serum vitamin D \< 20 ng/mL; re-screening for Vitamin D level \< 20 ng/mL will be allowed, after adequate supplementation
•Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 1.5 x upper limit of normal (ULN)
+25 more criteria

Locations (49)

Research Site

Los Angeles, California, United States

Research Site

Torrance, California, United States

Research Site

Aurora, Colorado, United States

Research Site

New Haven, Connecticut, United States

Research Site

Wilmington, Delaware, United States

Research Site

Decatur, Georgia, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Iowa City, Iowa, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Key Dates

Start Date

June 24, 2015

Primary Completion Date

March 26, 2022

Completion Date

March 26, 2022

Last Updated

December 28, 2022

Enrollment

153

ACTUAL participants

Conditions

Osteogenesis Imperfecta

Interventions

Denosumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

Inclusion Criteria

Exclusion Criteria

Effects of Bisphosphonates on OI-Related Hearing Loss

Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708

Boost Brittle Bones Before Birth

Evaluation and Intervention for the Effects of Osteogenesis Imperfecta

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid