Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

Exclusion Criteria

• •1. Previous treatment with a bisphosphonate, or other osteoporosis medication.
• •2. Metabolic bone disorders besides glucocorticoid-induced osteoporosis; other disorders treated with systemic glucocorticoids (inflammatory bowel disease, severe pulmonary disease, nephrotic syndrome, etc.).
• •3. Intent to treat with a tumor necrosis factor inhibitor or Interleukin 6 receptor antagonist during the first 6 months.
• •4. Glomerular filtration rate \< 30ml/min \[pediatric estimated glomerular filtration rate = 0.413\*(height/serum creatinine)\] 75
• •5. Planned orthopedic or other major surgery during the course of the study (at the time of enrollment)
• •6. Significant dental caries, or plans to undergo invasive oral procedures during the subsequent 12 months.
• •7. Known allergy to latex (drug packaging includes a natural rubber stopper), fructose intolerance or other denosumab contraindication.
• •8. 25-hydroxyvitamin D (25OHD) level \< 32 ng/dl. Subjects with 25OHD \<32 ng/ml may be given cholecalciferol and rescreened.
• •9. Hypocalcemia at screening (total serum calcium \< 8.5 mg/dl after correction for albumin level).
• •10. Chronic ventilator dependence, or other conditions increasing risk of participation.
• •11. Pregnancy, or refusal to use acceptable contraception or abstain during the protocol (post-pubertal female).