NCT02418273

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to evaluate denosumab as a novel treatment for bone loss in children treated with glucocorticoids for rheumatic disorders. Children with rheumatic disorders are at risk for low bone density and fractures from the inflammatory effects of the underlying disease, and also from direct effects of glucocorticoids on bone. 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 BMD in children with rheumatic disorders, age 4 to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen. Two different sequential doses will be administered to the intervention group and evaluation for safety and efficacy will be conducted at study visits. 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.

Conditions

• Osteoporosis
• Juvenile Rheumatoid Arthritis
• Dermatomyositis
• Polyarthritis
• Systemic Lupus Erythematosis
• Vasculitis
• Glucocorticoid-induced Osteoporosis

Interventions

Type	Name	Description
DRUG	denosumab	These subjects will receive two doses of denosumab.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2015-04-16
• Last updated: 2019-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study