Zoledronic Acid vs Placebo in Pediatric Glucocorticoid-induced Osteoporosis: A Randomized, Double-blind, Phase 3 Trial
| Autor: | Sarfaraz Sayyed, R. Paul Aftring, Nathalie Alos, Leanne M Ward, Mikhail Kostik, Ekaterina Alexeeva, Anne Marie Sbrocchi, Nazih Shenouda, Kebashni Thandrayen, Craig F Munns, Gangadhar Sunkara, Nick Shaw, Jacob L. Jaremko, David A. Cabral, Éva Hosszú, Shayne Taback, Celia Rodd, Raja Padidela, Anup Choudhury |
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| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Endocrinology Diabetes and Metabolism Clinical Biochemistry Osteoporosis Context (language use) Placebo Biochemistry Zoledronic Acid Endocrinology Double-Blind Method Internal medicine Clinical endpoint medicine Humans Adverse effect Child Glucocorticoids Bone mineral Bone Density Conservation Agents business.industry Biochemistry (medical) medicine.disease Prognosis Confidence interval Zoledronic acid Child Preschool Female business medicine.drug Follow-Up Studies |
| Zdroj: | The Journal of clinical endocrinology and metabolism. 106(12) |
| ISSN: | 1945-7197 |
| Popis: | Context Glucocorticoids (GCs) prescribed for chronic pediatric illnesses are associated with osteoporotic fractures. Objective This study aims to determine the efficacy and safety of intravenous (IV) zoledronic acid (ZA) compared with placebo to treat pediatric GC-induced osteoporosis (GIO). Methods Children aged 5 to 17 years with GIO were enrolled in this multinational, randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov NCT 00799266). Eligible children were randomly assigned 1:1 to 6 monthly IV ZA 0.05 mg/kg or IV placebo. The primary end point was the change in lumbar spine bone mineral density z score (LSBMDZ) from baseline to month 12. Incident fractures and safety were assessed. Results Thirty-four children were enrolled (mean age 12.6 ± 3.4 years [18 on ZA, 16 on placebo]), all with low-trauma vertebral fractures (VFs). LSBMDZ increased from −2.13 ± 0.79 to −1.49 ± 1.05 on ZA, compared with −2.38 ± 0.90 to −2.27 ± 1.03 on placebo (least squares means difference 0.41 [95% CI, 0.02-0.81; P = .04]); when corrected for height z score, the least squares means difference in LBMDZ was 0.75 [95% CI, 0.27-1.22; P = .004]. Two children on placebo had new low-trauma VF vs none on ZA. Adverse events (AEs) were reported in 15 of 18 children (83%) on ZA, and in 12 of 16 (75%) on placebo, most frequently within 10 days after the first infusion. There were no deaths or treatment discontinuations due to treatment-emergent AEs. Conclusion LSBMDZ increased significantly on ZA compared with placebo over 1 year in children with GIO. Most AEs occurred after the first infusion. |
| Databáze: | OpenAIRE |
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