Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
Status:
Withdrawn
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in
children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2,
randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone
resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age 4
to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen.
Primary outcomes include suppression of bone turnover markers and safety assessments.
Secondary outcomes include changes in bone density as measured by dual energy X-ray
absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) densitometry at
the radius and tibia.