Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02418273
Study type	Interventional
Source	Indiana University
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	August 1, 2019
Completion date	June 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06287502` - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis	N/A
Completed	`NCT03822078` - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women	Phase 1
Recruiting	`NCT05845021` - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04736693` - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Completed	`NCT02922478` - Role of Comorbidities in Chronic Heart Failure Study
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting	`NCT02616627` - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Active, not recruiting	`NCT02617303` - Prevention of Falls and Its Consequences in Elderly People	N/A
Completed	`NCT02566655` - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis	Phase 1
Completed	`NCT02559648` - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis	Phase 2
Completed	`NCT03420716` - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women	N/A
Not yet recruiting	`NCT02223572` - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture	N/A
Unknown status	`NCT01913834` - Nasally and sc Administered Teriparatide in Healthy Volunteers	Phase 1
Completed	`NCT02003716` - DeFRA Questionnaire as an Anamnestic Form	N/A
Not yet recruiting	`NCT01854086` - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday	N/A
Completed	`NCT01401556` - C-STOP Fracture Trial	N/A
Completed	`NCT01757340` - Calorie Restriction With Leucine Supplementation	N/A
Completed	`NCT02143674` - Muscle Strengthening Exercises and Global Stretching in Elderly	N/A