An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

• Status: Completed
• Trial end date: 2018-03-05
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Glucocorticoids; Zoledronic Acid

Criteria

Key Inclusion Criteria:

• A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within 12 months prior to screening

• Lumbar Spine BMDZ-score of -0.5 or worse

• Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or higher (or radiographic signs of vertebral fracture) within 1 month from Screening visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years PRECEDING enrollment in the study OR Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years PRECEDING enrollment in the study

• Consent/assent to study participation

Key Exclusion Criteria:

• History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis, Rickets/Osteomalacia)

• Any medical condition that might have interfered with the evaluation of lumbar spine BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of interest lumbar 1 (L1) to lumbar 4 (L4),

• Hypocalcemia and hypophosphatemia

• Serum 25-hydroxy vitamin D concentrations of <20 ng/mL or <50 nmol/L

• estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2

• serum creatinine increase between Visit 1 and Visit 2 >0.5 mg/dL (44.2 μmol/L)

• Uncontrolled symptoms of cardiac failure or arrhythmia

• Any prior use of bisphosphonates, or high dose sodium fluoride