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Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis

NCT03164928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-07-19

Study results available
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Summary

To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).

Conditions

  • Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With
  • Glucocorticoid-induced Osteoporosis

Interventions

DRUG

Denosumab

1mg/kg BW (up to a maximum of 60 mg) SC Q6M

OTHER

Placebo

SC Q6M placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2021-12-13
Completion
2023-12-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • India
  • Italy
  • Mexico
  • Peru
  • Russia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03164928 on ClinicalTrials.gov