Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Osteoporosis, Juvenile Rheumatoid Arthritis, Dermatomyositis, Polyarthritis, Systemic Lupus Erythematosis, Vasculitis, Glucocorticoid-induced Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT02418273
- Run by
- Indiana University
- People needed
- 0
- Starts
- 2019-08-01
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2019-12-06
Who can join
Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 4 to 16 years of age.
- Diagnosis of one of the following by a rheumatologist using standard criteria: juvenile dermatomyositis, juvenile idiopathic arthritis, systemic arthritis, seronegative or seropositive polyarthritis, psoriatic arthritis, systemic lupus or systemic vasculitis.
- Within 1 month of initiating glucocorticoids ≥0.5 mg/kg prednisone equivalent daily, planned for ≥ 6 months.
- BMD by DXA with Z-score < 0.0 on screening at lumbar spine or total body less head (TBLH).
You may not qualify if…
- Previous treatment with a bisphosphonate, or other osteoporosis medication.
- Metabolic bone disorders besides glucocorticoid-induced osteoporosis; other disorders treated with systemic glucocorticoids (inflammatory bowel disease, severe pulmonary disease, nephrotic syndrome, etc.).
- Intent to treat with a tumor necrosis factor inhibitor or Interleukin 6 receptor antagonist during the first 6 months.
- Glomerular filtration rate < 30ml/min [pediatric estimated glomerular filtration rate = 0.413*(height/serum creatinine)] 75
- Planned orthopedic or other major surgery during the course of the study (at the time of enrollment)
- Significant dental caries, or plans to undergo invasive oral procedures during the subsequent 12 months.
- Known allergy to latex (drug packaging includes a natural rubber stopper), fructose intolerance or other denosumab contraindication.
- 25-hydroxyvitamin D (25OHD) level < 32 ng/dl. Subjects with 25OHD <32 ng/ml may be given cholecalciferol and rescreened.
- Hypocalcemia at screening (total serum calcium < 8.5 mg/dl after correction for albumin level).
- Chronic ventilator dependence, or other conditions increasing risk of participation.
- Pregnancy, or refusal to use acceptable contraception or abstain during the protocol (post-pubertal female).
Where it is running
- Indiana University School of Medicine — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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